THE DRUGS AND COSMETICS ACT, 1940 AND RULES, 1945

By Dr. Bhaskar Chaurasia M.Pharma, Phd Director, Rajiv Institute, Barigarh, Chhatarpur (M.P.)

THE DRUGS AND COSMETICS ACT, 1940 AND RULES, 1945 INTRODUCTION In 1937 a Bill was introduced in the Central Legislative Assembly to give effect to the recommendations of the Drugs Enquiry Committee to regulate the import of drugs into British India. This Bill was referred to the Select Committee and the Committee expressed the opinion that a more comprehensive measure for the uniform control of manufacture and distribution of drugs as well as of imports was desirable. The Central Government suggested to the Provincial Governments to ask the Provincial Legislatures to pass resolutions empowering the Central Legislature to pass on Act for regulating such matters relating to control of drugs as fall within the Provincial sp here. Provincial Governments got the resolution passed from the Provincial Legislatures and sent them to the Central Government for getting through the Bill to regulate the import, manufacture, distribution and sale of Drugs and Cosmetics. Thereupon the Drugs and Cosmetics Bill was introduced in the Central Legislative Assembly. Statement of Objects and Reasons In order to give effect to the recommendations of the Drugs Enquiry Committee, in so far as they relate to matters with which the Central Government is primarily concerned, a Bill to regulate the import of drugs into British India was introduced in the Legislative Assembly in 1937. The Select Committee appointed by the Legislative Assembly was of the opinion that a more comprehensive measure providing for the uniform control of the manufacture and distribution of drugs as well as of import was desirable. The Government of India accordingly asked Provincial Governments to invite the Provincial Legislatures to pass resolutions under section 103 of the Government of India Act, 1935, empowering the Central Legislature to pass an Act for regulating such matters relating to the control of drugs as fall within the Provincial Legislative List. Such resolutions have now been passed by all Provincial Legislatures. The Bill establishes a Board of Technical Experts to advise the Central and Provincial Governments on technical matters. Provides for the control of the import of drugs into British India. The executive power under this chapter will accordingly be exercised by the Central Government. Relates to control of the manufacture, sale and distribution of drugs and contains the provisions which it is proposed should be enacted in exercise of the powers conferred by the resolutions under section 103 of the Government of India Act passed by the Provincial Legislatures. The executive power under Chapter IV will be exercised by the Provincial Government. The First Schedule prescribes the standards to be complied with by imported drugs and the Second Schedule prescribes the standards to be complied with the drugs manufactured, sold or distributed in India. The standards prescribed in the two Schedules are identical. The Central Government will have power to amend the First Schedule, but power to amend the Second Schedule will rest with Provincial Government. The Government of India have considered to what extent provision can be made to secure the maintenance of uniformity in standards and in other important matters in which uniformity is desirable. They understand that

it would be ultra vires of Central Legislature to assign to any authority other than the Provincial Government's authority conferred by the Bill in respect of matters falling within the Provincial Legislative field. For this reason it is not possible to assign the power to fix standards and to make rules to any single authority. In order to assure that before any action is taken due consideration is given to the desirability of maintaining uniformity, provision has been made in Chapter VI for a single Technical Advisory Board which both Central and Provincial Government will be required to consult before modifying the standards set up by the Bill or before making rules under the Bill. THE DRUGS AND COSMETICS ACT, 1940 The Indian Legislature passed the Drugs and Cosmetics Act 1940 with the object to regulate the import, manufacture and distribution and sale of drugs. It is applicable on Allopathic, Homeopathic, Unani and Siddha drugs as well on contraceptives, mosquito repellents, creams, lotions, cosmetics and devices used for internal and external use for diagnosis. Under the Drugs and Cosmetics Act 1940, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the state Authorities while the Central Authorities are responsible for approval of New Drugs, clinical trials in the country, laying down standards for Drugs, control over the quality of imported drugs, coordination of the activities of Drug Control Organization and providing expert advice with a view of bringing about uniformity in the enforcement of Drug and Cosmetic Act. Aims An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics. Whereas it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics. Objectives o The Drugs and Cosmetics Act 1940 provides the central legislation, which regulates import, manufacture, distribution & sale of drugs & cosmetics in the country. o The main objective of the Act is to ensure that the drugs available to the people are safe and efficacious and the cosmetics marketed are safe for use. o The D &C Act regulate the import of drugs into India so that no substandard or spurious drugs get imported in India. o This Act regulates the manufacture of drugs so that no substandard or spurious drugs get manufactured in the country. o This Act provides the regulation of sale and distribution of drugs and cosmetics whereby only qualified and trained persons can undertake their handling, compounding and distribution. o This Act also provides the regulation of manufacture and sale and distribution of Ayurveda, Siddha, Unani and Homeopathic drugs.

o This Act enables to have regular inspection of licence premises by Drug inspectors. o This Act enables to have control over the standerds over the drugs and cosmetics by taking samples and by getting them tested and analysed in the Drug Control Laboratories of State and Centre. o To provide special provisions to regulate the preparations, standardizations and storage of biological and other special products. o To prescribe the manner of labeling and packaging of various classes of drugs and cosmetics. This Act also provides for constitution of two Boards namely The Drugs Technical Advisory Board and Ayurvedic and Unani Drugs Technical Advisory Board to advice the Central and State Governments on technical matters and to carry out the other functions assigned to it by this Act. It also provides for the establishment of two Drugs Consultative Committees, one for the Allopathic and other for the Ayurvedic, Siddha and Unani Drugs to advice the various Governments and Boards on Matters tending to secure uniformity throughout the country in the administration of the act. There are two schedules to the Drug and Cosmetic Act and more than thirty schedules to the rules. Brief History o The Drugs Act was enacted in 1940 o The Drugs Rules were promulgated in December 1945 and the enforcement started in 1947. o The Act as enacted in 1940 has since been amended several times. o It is now titled as Drugs and Cosmetics Act and Rules. The Central Drug Standard Control Organisation o The Central Drugs Standard Control Organisation (CDSCO) headed by the Drugs Controller General India (DCGI) discharges the functions allocated to Central Government. o The CDSCO is attached to the office of the Director General of Health Services in the Ministry of Health and Family Welfare. Schedules to the Act 1940. Drugs Controller General India The DCGI (Drugs Controller General India) is a statutory authority under the Act and has port offices, zonal offices with drug inspectors and drug testing laboratories functioning under him. Functions of the Central Government The main functions of the central government are; o Approval of new drugs introduced in the country. o Permission to conduct clinical trials.

o Registration and control on the quality of imported drugs. o Laying down regulatory measures and amendment of Acts and Rules. o Laying down standards for drugs, cosmetics, diagnostics and devices and updating IP. o Approval of Licenses as Central License Approving Authority for manufacture of large volume parenterals and vaccines and operation of blood banks and also of such other drugs as may be notified by Govt. from time to time. o Coordinating the activities of the States and advising them on matters relating to uniform administration of the Act and Rules in the country. DEFINITIONS (a) Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani (Tibb) systems of medicine, specified in the First Schedule; (aa) The Board means (i) in relation to Ayurvedic, Siddha or Unani drug, the Ayurvedic, Siddha or Unani Drugs Technical Advisory Board constituted under section 33C (Ayurvedic, Siddha and Unani Drugs Technical Advisory Board); and (ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted under section 5 (The Drugs Technical Advisory Board); (aaa) Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applicated to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. (b) Drug includes (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances other than food intended to affect the structure or any function of human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (iii) all substances intended for use as components of a drug including empty gelatin capsules; and (iv)such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board ; (c) Government Analyst means-

(i) in relation to Ayurvedic, Siddha or Unani drug, a Government Analyst appointed by Central Government or a State Government under section 33F (Government Analysts); and (ii) in relation to any other drug or cosmetic , a Government Analyst appointed by the Central Government or a State Government under section 20(Government Analysts); (d) Inspector means (i) in relation to Ayurvedic, Siddha3 or Unani drug, an Inspector appointed by the Central Government or a State Government under section 33G(Inspectors); and (ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central Government or a State Government under section 21; (e) Manufacture in relation to any drug or cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business; and to manufacture shall be construed accordingly; (f) To import, with its grammatical variations and cognate expressions means to bring into India; (g) Patent or proprietary medicine means, -(i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books; (ii) in relation to any other systems of medicine, a drug which is a remedy or (i) prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5(The Drugs Technical Advisory Board); (h) Homoeopathic medicines include any drug which is recorded in Homoeopathic proving or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route. (i) Central Licence Approving Authority means the Drugs Controller, India, appointed by the Central Government. (j)Director means the Director of the Central Drugs Laboratory; (k) Laboratory means the Central Drugs Laboratory; (l) Registered Homeopathic medical practitioner means a person who is registered in the Central Register or State Register of Homeopathy; (ll) Registered medical practitioner means a person__

(ii) (i)holding a qualification granted by an authority specified or notified under Section 3 of the Indian Medical Degrees Act, 1916, or specified In the Schedules to the Indian Medical Council Act, 1956; or (iii) registered or eligible for registration in a medical register of a State meant for the registration of persons practicing the modern scientific system of medicine excluding the Homoeopathic system of medicine; or (iv)registered in a medical register, other than a register for the registration of Homoeopathic practitioner, of a State, who although not falling within subclause (i) or sub-clause (ii) declared by a general or special order made by the State Government in this behalf as a person practicing the modern scientific system of medicine for the purposes of this Act; or (v) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948; or (vi)who is engaged in the practice of veterinary medicine and who possesses qualification approved by the State Government. (m) Retail sale means a sale whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person] other than a sale by way of wholesale dealing; (n) Sale by way of wholesale dealing means sale to a person for the purpose of selling again and includes sale to a hospital, dispensary, medical, educational or research institution. (o) Schedule means a Schedule to these Rules. (p) Poisonous substance means a substance specified in Schedule E. SCHEDULLES SCHEDULLES OF THE DRUGS AND COSMETICS ACT, 1940: The D & C Act has two schedules. First schedule of the act List of authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicines.

Second Schedule of the Standards to be complied with by imported drugs manufactured for Act sale, stocked or exhibited for sale or distributed. SCHEDULLES TO THE RULES, 1945: Schedule A Schedule B - Specimens of the prescribed forms for making application for licences, issue & renewal of licences, for sending memorandum etc.

-Rates of fee for test or analysis by the CDL or State drug laboratories. Eg. Pyrogen Test INR 500/- Bioassay of Antibiotic INR 400/- etc. Schedule C & -List of biological products & other special products whose import,

C1 Schedule C Schedule CI

manufacture, sale & distribution are governed by special provision. -List of biological and special products like Ophthalmic preparations, Parenteral preparations and Sterile disposable Devices, whose import, manufacture, sale and distribution are governed by special provisions. -List of other Special products, Liver special products like Digitalis, Adrenaline, Liver extract preparations and Vitamins, Antibiotics, Hormones preparations other than injections, whose import, manufacture, sale and distribution are governed by special provisions. -List of drugs that are exempted from certain provisions that are applicable to the import of drugs. -Registration of the manufacturer or his authorized agent for import of drugs and to use further in manufacturing. -Registration of bulk drugs/Formulations/Special products for its import in India. - (Omitted in June 1982) List of exemption to certain allopathic poisonous substances. -List of poisonous substances under Ayurvedic, Siddha & Unani System. Drugs of plant origin Drugs of animal origin Drugs of mineral origin -Special provisions applicable to the production, testing, storage, packing & labeling of biological & other special products. Schedule F: Equipment, supply, GMP/SOP, Sterile air classification, Master formula, Quality Assurance for Blood Banks, Blood donation. Schedule F1: Special provisions applicable to vaccines, Antiseras and Diagnostic Antigens in respects of production, testing, storing labeling and packing. -Standards for surgical dressing. -Standards for umbilical tapes. -Details of the standards - ophthalmic preparations -List of substances that are required to be used under medical supervision & which are labelled to be accordingly. Eg. Aminopterin, Ethosuximide, Pheniramine etc. -List of substances that should be sold by retail only on the prescription of a registered medical practitioner (List of prescription drugs). Eg.- Diclofenac, ciprofloxacin, Inj.Ranitidine, etc -(Omitted in June 1982) Particulars regarding calculation of proportions of poisons. -Diseases or ailments which a drug may not purport or cure or make claims to prevent or cure. Eg. - AIDS, Angina pectoris.

Schedule D Schedule D1 Schedule D2 Schedule E Schedule E1

Schedule F & F1

Schedule F2 Schedule F3 Schedule FF/F4 Schedule G

Schedule H

Schedule I Schedule J

Schedule K Schedule L Schedule M Schedule MI Schedule MII Schedule MIII Schedule N Schedule O Schedule P Schedule P1 Schedule Q Schedule R Schedule R1 Schedule S Schedule T Schedule U Schedule UI Schedule V Schedule W Schedule X

-List of drugs that are exempted from certain provisions relating to the manufacture of the drugs. -(Omitted in June 1982) List of certain prescription drugs. -GMP & requirements of Factory premises, plants & equipments. For manufacture of Homoeopathic drugs. For manufacture of Cosmetics. - For manufacture of medical devices. -List of minimum equipments (apparatus) and books which a pharmacy should possess. -Classification and Standards for disinfectant fluids. -Life periods and storage conditions for certain drugs. -Pack sizes of drugs for marketing. -List of Coal Tar Dyes, coloring agents & pigments permitted to be used to be used in cosmetics & soaps. -Sampling, testing and Standards for Condom and mechanical contraceptives. -Standards for medical devices. -Standards for Cosmetics. -GMP for Ayurvedic, Siddha & Unani medicines. -Particulars to be shown in manufacturing, raw materials & analytical records of drugs. -Particulars to be shown in manufacturing, raw materials & analytical records of drugs. -Standards for patent & proprietary medicines. - (Omitted in Feb 2000) List of drugs which shall be marketed under generic names. -List of drugs whose import, manufacture & sale, labelling & packaging are governed by special provisions.

Schedule Y

-Requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials

ADMINISTRATION OF THE ACT AND RULES Advisory 1. The Drugs Technical Advisory Board. 2. The Drugs Consultative Committee. Analytical 1. The Central Drugs Laboratory 2. Drug Control Laboratories in State 3. Government Analyst Executive 1. Licensing Authorities 2. Controlling Authorities 3. Drug Inspectors 4. Customs Collectors THE DRUGS TECHNICAL ADVISORY BOARD A. The Drugs Technical Advisory Board (DTAB) Constitution and Composition: DTAB is constituted by Central Government Under section 5 of the Act. (1) The Central Government shall constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act. (2) The Board shall consist of 18 members, of whom 8 are ex-officio, 5 nominated and 5, elected members, as followsEx-officio Members(i) (ii) (iii) (iv) (v) (vi) The Director General of Health Services, ex officio, who shall be Chairman; The Drugs Controller, India ex-officio; The Director of the Central Drugs Laboratory, Calcutta, ex-officio; The Director of the Central Research Institute, Kasauli, ex-officio; The Director of the Indian Veterinary Research Institute, Izatnagar, ex-officio; The President of the Medical Council of India, ex-officio;

(vii) (viii)

The President of the Pharmacy Council of India, ex-officio; The Director of the Central Drug Research Institute, Lucknow, ex-officio; Elected and Nominated Members(ix) Two persons to be nominated by the Central Government from among persons who are in charge of drugs control in the States; (x) One person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college affiliated thereto; (xi) One person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto; (xii) One person to be nominated by the Central Government from the pharmaceutical industry; (xiii) One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research; (xiv) One person to be elected by the Central Council of the Indian Medical Association; (xv) One person to be elected by the Council of the Indian Pharmaceutical Association; (xvi) Two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government. (3) The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election. (4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it. (5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, not exceeding three years, as it may decide, or temporarily for the consideration of particular matters, persons who are not members of the Board. (6) The functions of the Board may be exercised notwithstanding any vacancy therein. (7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary. B. Function of DTAB o To advise the Central and State Government on the technical matters arising out of the administration of the Act.

o To carry out such other functions as may be intrusted to it by the Central Government. THE CENTRAL DRUGS LABORATORY A. The Central Drugs Laboratory (CDL) CDL established by Central Government under section 6. (1) The Central Government shall establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act. If the Central government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or cosmetic or class of cosmetics shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or cosmetic or class of cosmetics shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be. (2) The Central Government may, after consultation with the Board, make rules prescribing (i) The functions of the Central Drugs Laboratory; (ii) The procedure for the submission of the said Laboratory of samples of or cosmetics for analysis or test, the forms of the Laboratorys reports thereon and the fees payable in respect of such reports ; (iii) Such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions; (iv)The matters necessary to be prescribed for the purposes of the proviso to subsection (1). B. Functions of CDL:(1) It shall be the function of the Laboratory(i) to analyse or test such samples of drugs as may be sent to it by Custom officers under the law related to the sea customs, or test such samples submitted by Government Analyst under this act; (ii) to carry out such other duties as may be entrusted to it by the Central Government or, with the permission of the Central Government, by a State Government after consultation with the Drugs Technical Advisory Board. (2) The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute:-(1) Sera (2) Solution of serum proteins intended for injection (3) Vaccines (4) Toxins (5) Antigens

(6) Anti-toxins (7) Sterilized surgical ligature and sterilized surgical suture. (8) Bacteriophages. Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central Research Institute, Kasauli only. (2A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes and the functions of the Director in respect of the said drugs shall be exercised by Director of the respective Institutes :-(a) Pasteur Institute of India, Coonoor. (b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute Compound, Parel, Bombay-400012. (c) The National Institute of Biologicals, NOIDA. (3) The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes. (1) Anti-sera for veterinary use. (2) Vaccines for veterinary use. (3) Toxoids for veterinary use. (4) Diagnostic Antigens for veterinary use. (4) The functions of the laboratory in respect of condoms shall be carried out at the Central Indian Pharmacopoeia Laboratory, Ghaziabad, and the functions of the Director in respect of the said condoms shall be exercised by the Director of the said Laboratory. (5) The functions of the Laboratory in respect of the following drug shall be carried out at the Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta and the functions of the Director in respect of the said drug shall be performed by the Serologist and Chemical Examiner of the said Laboratory: __ (6) The function of the Laboratory in respect of Intra-Utrine Devices and falope Rings shall be carried out at the Central Drug Testing Laboratory, Thane, Maharashtra and the functions of the Director in respect of the said devices shall be exercised by the Director of the said Laboratory. (7) The functions of the Laboratory in respect of human blood and human blood products including components, to test for freedom of HIV antibodies, shall be carried out by the following Institutes, Hospitals and the functions of the Director in respect of the above mentioned products shall be exercised by the head of the respective Institutes, namely:-(a) National Institutes of Communicable Disease, Department of Microbiology, Delhi. (b) National Institute of Virology, Pune (c) Centre of Advanced Research in Virology, Christian Medical College, Vellore. (8) The functions of the Laboratory in respect of Homoeopathy shall be carried out at the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad and the function of the director in respect of the Homeopathic medicine shall be exercised by the Director of the laboratory. (9) The functions of the Laboratory in respect of Blood Grouping reagent and diagnostic kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C

Virus shall be carried out at the National Institute of Biologicals, NOIDA and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said laboratory. Dispatch of samples for test or analysis to CDL: Samples for test or analysis under shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director. The packet as well as the outer cover shall be marked with a distinguishing number. A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director. Recording of condition of seals: On receipt of the packet, it shall be opened by an officer authorized in writing in that behalf by the Director who shall record the condition of the seal on the packet. Report of result of test or analysis: After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2. Fees: The fees for test and analysis shall be those specified in Schedule B. Signature of certificates: Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorized by the Central Government by notification in the official Gazette to sign such certificates. THE DRUGS CONSULTATIVE COMMITTEE A. The Drugs Consultative Committee (DCC) The Central Government may constitute an advisory committee to be called "the Drugs Consultative Committee". The Drugs Consultative Committee (DCC) is constituted under section 7 of the Act. B. Constitution of DCC o The Drugs Consultative Committee shall consist of two representatives of the Central Government to be nominated by Central Government, and o One representative of each State Government to be nominated by the State Government. C. Power of DCC The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure. D. Functions of DCC o To advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any matter tending to secure uniformity throughout India in the administration of this Act.

o To carry out such other functions as may be entrusted to it by the Central Government. Nothing discusses above in respect of The Drugs Technical Advisory Board and the The Drugs Consultative Committee applies to Ayurvedic, Siddha and Unani drugs. GOVERNMENT ANALYSTS A. Government Analysts Government Analysts appointed by Central or State Government under section 20 of the Act. (1) The State Government may, by notification in the Official Gazette, appoint such persons, having the prescribed qualifications, to be Government Analysts for such areas in the state and in respect of such drugs or classes of drug or such cosmetics or classes of cosmetics as may specified in the notification. (2) The Central Government may also appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts in respect of such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be specified in the notification. (3) Notwithstanding anything contained in above sub-sections neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving. (4) No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be a Government Analyst under this Act. B. Qualifications of Government Analyst A person appointed as a Government Analyst under the Act shall be (a) A person who is a graduate in medicine or science or pharmacy or pharmaceutical chemistry of a University established in India by law or has an equivalent qualification recognized by the Central Government for such purpose and has had not less than five years post-graduate experience in the testing of drugs in a laboratory under control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority, or has Completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory, or (b) A person who possesses a post-graduate degree in medicine or science or pharmacy or Pharmaceutical chemistry of a University established in India by law or has an equivalent qualification recognized by the Central Government for such purpose or possesses the Associateship Diploma of the Institution of Chemists (India) obtained by passing the said examination with Analysis of Drugs and Pharmaceuticals as one of the subjects and has had after obtaining the said postgraduate degree or diploma not less than three years experience in the testing of drugs in a laboratory under the control ofa Government Analyst appointed under the Act, or

(i)

(ii)

the head of an Institution or testing laboratory approved for the purpose by the appointing authority or has completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory; Provided that(i) for purpose of examination of items in Schedule C, -(ia) the persons appointed under above clauses and having degree in Medicine, Physiology, Pharmacology, Microbiology, Pharmacy should have experience or training in testing of said items in an institution or laboratory approved by the appointing authority for a period of not less than six months; (ib) the person appointed under above clause but not having degree in the above subjects should have experience or training in testing of said Schedule C drugs for a period of not less than three years in an institution or laboratory approved by the appointing authority or have completed two years training on testing of drugs including items stated in Schedule C in Central Drugs Laboratory; (ii) for a period of four years from the date on which this part of the Act takes effect in the States, persons whose training and experience are regarded by the appointing authority as affording, subject to such further training, if any, as may be considered necessary, a reasonable guarantee of adequate knowledge and competence, may be appointed as Government Analysts. The persons so appointed may, if the appointing authority so desires, continue in service after the expiry of the said period of four years. (iii) no person who is engaged directly or indirectly in any trade or business connected with the manufacture of drugs shall be appointed as a Government Analyst for any area. Provided further that for the purpose of examination of Anti-sera, Toxoid and Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a person who is a graduate in Veterinary Science, or general science, or medicine or pharmacy and has had not less than five years experience in the standardization of biological products or person holding a post-graduate degree in Veterinary Science, or general science, or medicine or pharmacy or pharmaceutical chemistry with an experience of not less than three years in the standardization of biological products. Provided also that persons, already appointed as Government Analysts may continue to remain in service, if the appointing authority so desires, notwithstanding the fact that they do not fulfil the qualifications. C. Duties of Government Analysts (1) The Government Analyst shall cause to be analysed or tested such samples or drugs and cosmetics as may be sent to him by Inspectors or other persons under this Act and shall furnish reports of the results of test or analysis. (2)A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government. D. PROCEDURE I. Procedure followed by Government Analyst on receipt of sample:

On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet or on portion of sample or container with the specimen impression received separately and shall note the condition of the seals on the packet or on portion of sample or container. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied: It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of protocols of the tests or analysis applied, if---(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report; (2)for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report; (3)for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report; (4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report; (5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report. II. Reports of Government Analysts (1) The Government Analyst to whom a sample of any drug or cosmetic has been submitted for test or analysis, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form. (2)The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed, and shall retain the third copy for use in any prosecution in respect of the sample. (3)Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence to the facts stated therein, and such evidence shall be conclusive unless the person from whom the sample was taken or the person whose name, address and other particulars have been disclosed has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report. (4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analysts report, the Court may, of its own

motion or in its discretion at the request either of the complainant or the accused, cause the sample of the drug or cosmetic produced before the Magistrate to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by, or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein. (5) The cost of a test or analysis made by the Central Drugs Laboratory under subsection (4) shall be paid by complainant or accused as the Court shall direct. III. Report of result of test or analysis An application from a purchaser for test or analysis of a drug under Section 26 of the Act shall be made in Form 14-A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14-B. IV. Fees The fees to be paid by a person submitting to the Government Analyst under Section 26 of the Act for test or analysis of a drug purchased by him shall be those specified in Schedule B. LICENSING AUTHORITY A. Licensing Authority Any application for the grant or renewal of a licence for import, manufacturing, sale, etc. of any drug or cosmetic is to be made to the Licensing Authority. The qualification of Licensing Authority has been recently prescribed under the new Rule 50A by D & C (9th Amendment) Rules, 1989. B. Qualification of a Licensing Authority No person shall be qualified to be a Licensing Authority under the Act unless:-(i) He is a graduate in Pharmacy on Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and (ii) He has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years. Provided that the requirements as to the academic qualification shall not apply to those inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989. C. Power & Functions The licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licences and Registration Certificate and such other powers as may be specified in the order to any other person under his control. D. Procedure of Licensing Authority or Central Licence Approving Authority (1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the Rules under the Act have been

complied with and that the conditions of the licence and the Rules under the Act will be observed, he shall issue a licence under this Part. (2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted and shall supply the applicant with a copy of the inspection report CONTROLLING AUTHORITY A. Controlling Authority (1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central government. (2) All Inspectors appointed by the State Government shall be under the control of an officer appointed in this behalf by the State Government. (3) For the purposes of these rules an officer appointed by the Central Government, or as the case may be, an officer appointed by the State Government, shall be a controlling authority. The qualification of controlling authority has been recently prescribed under the new Rule 50A by D & C (9th Amendment) Rules, 1989. B. Qualification of a Controlling Authority (1) No person shall be qualified to be a controlling Authority under the Act unless.-(i) He is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical Pharmacology or microbiology from a University established in India by law and (ii) He has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years. Provided that the requirements as to the academic qualifications shall not apply to those Inspectors and the Government Analysts, who were holding those positions on the 12th day of April, 1989. C. Power The power of a person or an organized assemblage of persons to manage, direct, superintend, restrict, regulate, govern, administer or oversee. DRUGS INSPECTORS A. Drugs Inspectors Drugs Inspectors appointed by Central or State Government under section 21 of the Act. (1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such person, having the prescribed qualification, to be Inspectors for such areas as may be assigned to them by the Central Government or State Government, as the case may be. (2) The powers which may be exercised by an Inspector and the duties which may be performed by him, the drugs or classes of drugs or cosmetics or classes of cosmetics in

relation to which and the conditions, limitations or restrictions subject to which, such powers and duties may be exercised or performed shall be such as may be prescribed. (3) No person who has any financial interest in the import, manufacture or sale of drugs or cosmetics shall be appointed to be an Inspector under this section. (4) Every Inspector shall be deemed to be public servant within the meaning of section 21 of the Indian Penal Code, 1860, and shall be officially subordinate to such authority having the prescribed qualification as the Government appointing him may specify in this behalf. B. Qualifications A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in clinical Pharmacology or Microbiology from a University established in India by law: Provided that only those Inspectors: -(i) Who have not less than 18 months experience in the manufacture of atleast one of the substances specified in Schedule C, or (ii) Who have not less than 18 months experience in testing of atleast one of the substances in Schedule C in a Laboratory approved for this purpose by the licensing authority, or (iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspector; shall be authorised to inspect the manufacture of the substances mentioned in Schedule C. Provided further that the requirement as to the academic qualification shall not apply to the persons appointed as Inspectors on or before the 18th day of October, 1993. C. Powers of Inspectors (1) Subject to the provisions of procedure of Inspectors and of any rules made by the Central Government in this behalf, within the local limits of the area for which an Inspector is appointed, (a) an Inspector may, inspect, (i) any premises wherein any drug or cosmetic is being manufactured and the means employed for standardizing and testing the drug or cosmetic; (ii) any premises wherein any drug or cosmetic is being sold, or stocked or exhibited or offered for sale, or distributed ; (b) an Inspector may, take samples of any drug or cosmetic,(i) which is being manufactured or being sold or is stocked or exhibited or offered for sale, or is being distributed; (ii) taking samples from any person who is in the course of conveying, delivering or preparing to deliver such drug or cosmetic to a purchaser or a consignee; (c) at all reasonable times, with necessary assistance-(i) an Inspector may, search any person, who, he has reason to believe, has secreted about his person, any drug or cosmetic in respect of which an offence under this part of the act has been, or is being, committed; or

(ii) an Inspector may, enter and search any place in which he has reason to believe an offence under this Act has been, or is being committed; or (iii) an Inspector may, stop and search any vehicle, vessel, or other conveyance which, he has reason to believe, is being used for carrying any drug or cosmetic in respect of which an offence under this Act has been, or is being, committed, and order in writing the person in possession of the drug or cosmetic in respect of which the offence has been, or is being, committed, not to dispose of any stock of such drug or cosmetic for a specified period not exceeding twenty days, or, unless the alleged offence is such that the defect may be removed by the possessor of the drug or cosmetic, seize the stock of such drug or cosmetic and any substance or article by means of which the offence has been ,or is being, committed or which may be employed for the commission of such offence; (cc) an Inspector may, examine any record, register, document or any other material object found with any person, or in place, vehicle, vessel or other conveyance referred to in clause (c), and seize the same if he has reason to believe that it may furnish evidence of the commission of an offence punishable under this Act or the Rules made thereunder; (cca) an Inspector may ,require any person to produce any record, register, or other document relating, to the manufacture for sale or for distribution, stocking, exhibition for sale, offer for sale or distribution of any drug or cosmetic in respect of which he has reason to believe that an offence under this Act has been, or is being, committed; (2) The provisions of the Code of Criminal Procedure, shall, so far as may be, apply to any search or seizure under this part of the act as they apply to any search or seizure made under the authority of a warrant issued under section 94 of the said Code. (2A) Every record, register or other document seized or produced shall be returned to the person, from whom they were seized or who produce the same, within a period of twenty days of the date of such seizure or production, as the case may be, after copies thereof or extracts there from certified by that person, in such manner as may be prescribed, have been taken. (3) If any person willfully obstructs an Inspector in the exercise of the powers conferred upon him by or under this act or refuses to produce any record, register or other document when so required, he shall be punishable with imprisonment which may extend to three years, or with fine, or with both. D. Procedure of Inspectors (1) Where an Inspector takes any sample of a drug or cosmetic under this par of the act, he shall tender the fair price thereof and may require a written acknowledgement therefor. (2) Where the price tendered is refused, or where the Inspector seizes the stock of any drug or cosmetic, he shall tender a receipt therefore in the prescribed form. (3) Where an Inspector takes a sample of a drug or cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in the prescribed form to the person from whom he takes it and, in the presence of such person unless he willfully absents himself, shall divide the sample into four portions and effectively seal and suitably mark the same and permit such person to add his own seal and mark to all or any of the portions so sealed and marked. Provided that where the sample is taken from premises whereon the drug or cosmetic is being manufactured, it shall be necessary to divide the sample into three portions only. Provided further that where the drug or cosmetic is made

up in containers of small volume, instead of dividing a sample as aforesaid, the Inspector may, and if the drug or cosmetic be such that it is likely to deteriorate or be otherwise damaged by exposure shall, take three or four, as the case may be, of the said containers after suitably marking the same and, where necessary, sealing them. (4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall retain the remainder and dispose of the same as follows: -(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis; (iv)the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug or cosmetic; (v) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A(Disclosure of the name of the manufacturer). (5) Where an Inspector takes any action under the provision related to his powers -(i) he shall use all dispatch in ascertaining whether or not the drug or cosmetic contravenes any of the provisions related to the Prohibition of manufacture and sale of certain drugs and cosmetics under section 18 and, if it is ascertained that the drug or cosmetic does not so contravene, forthwith revoke the order passed under the said clause or, as the case may be take, such action as may be necessary for the return of the stock seized; (ii) if he seizes the stock of the drug or cosmetic, he shall as soon as may be, inform a Judicial Magistrate and take his orders as to the custody thereof; (iii) without prejudice to the institution of any prosecution, if the alleged contravention be such that the defect may be remedied by the possessor of the drug or cosmetic, he shall, on being satisfied that the defect has been so remedied, forthwith revoke his order under the said clause. (6) Where an Inspector seizes any record, register, document or any other material object under clause power of Inspectors according to this act,he shall, as soon as may be, inform a Judicial Magistrate and take his orders as to the custody thereof. Persons bound to disclose place where drugs or cosmetics are manufactured or kept: Every person for the time being in charge of any premises whereon any drug or cosmetic is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, be legally bound to disclose to the Inspector the place where the drug or cosmetic is being manufactured or is kept, as the case may be. E. Duties of Inspectors I. Duties of Inspectors of premises licensed for sale: Subject to the instructions of the controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for the sale of drugs(1) to inspect not less than once a year all establishments licensed for the sale of drugs within the area assigned to him; (2) to satisfy himself that the conditions of the licences are being observed;

(3) to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules thereunder; (4) to investigate any complaint in writing which may be made to him; (5) to institute prosecutions in respect of breaches of the Act and Rules thereunder; (6) to maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and the seizure of stocks, and to submit copies of such record to the controlling authority; (7) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention to the Act; (8) when so authorized by the State Government, to detain imported packages which he has reason to suspect contain drugs, the import of which is prohibited. II. Inspection of Manufacture of Drugs: Duties of Inspectors specially authorized to inspect the manufacture of drugs or Cosmetics:Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs--(1) to inspect not less than once a year, all premises licensed for manufacture of drugs or cosmetics within the area allotted to him to satisfy himself that the conditions of the licence and provisions of the Act and Rules thereunder are being observed; (2) in the case of establishments licensed to manufacture products specified in Schedule C and C(1) to inspect the plant and the process of manufacture, the means employed for standardizing and testing the drugs or cosmetics, the methods and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the product; (3) to send forthwith the controlling authority after each inspection a detailed report indicating the conditions of the licence and provisions of the Act and Rules thereunder which are being observed and the conditions and provisions, if any, which are not being observed. (4) to take samples of the drugs or cosmetics manufactured on the premises and send them for test or analysis in accordance with these Rules; (5) to institute prosecutions in respect of breaches of the Act and Rules thereunder. III. Prohibition of sale; No person in possession of a drug or cosmetic in respect of which an Inspector has made an order according to the provision of his power under this Act shall in contravention of that order sell or otherwise dispose of any stock of such drug or cosmetic. IV. Forms of receipts for seized drug, cosmetic, record register, document or any other material object; A receipt by an Inspector for the stock of any drug or cosmetic or for any record, register, document or any other material object seized by him according to the provision of his power under this Act shall be in Form 16. V. Manner of certifying copies of seized documents;

The Drugs Inspector shall return the documents , seized by him under this act or produced before him according to the provision of his power under this Act, within a period of twenty days of the date of such seizure or production, to the person from whom they have seized or, as the case may be, the person who produced them, after copies thereof extracts therefrom have been singed by the concerned Drug Inspector and the person from whom they have seized , or, as the case may be , who produced such records. VI. Form of intimation of purpose of taking samples; When an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it. VII. Form or receipt for samples of drugs where fair price tendered is refused; Where the fair price, for the samples of drugs taken for the purpose of test or analysis, tendered under section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17-A; VII. Procedure for dispatch of sample to Government Analyst; The portion of sample or the container sent by an Inspector to the Government Analyst for test or analysis under Section 23(Procedure of Inspectors) of the Act shall be sent by registered post or by hand in a sealed packet, enclosed together with a memorandum in Form 18, in an outer cover addressed to the Government Analyst. A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the Government Analyst separately by registered post or by hand. IX. Procedure for disposal of confiscated drugs; (1) The Court shall refer the confiscated drugs to the Inspector concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the Rules in any respect. (2) If the Inspector, on the basis of Government Analysts report finds the confiscated drugs to be not of standard quality or to contravene any of the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. The Court shall thereupon order the destruction of the drugs. The destruction shall take place under the supervision of the Inspector in the presence of such authority, if any, as may be specified by the Court. (3) If the Inspector finds that the confiscated drugs are of standard quality and do not contravene the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. The Court may then order the Inspector to give the stocks of confiscated drugs to hospital or dispensary maintained or supported by the Government or by Charitable Institution. IMPORT OF DRUGS AND COSMETICS Import and Registration: Government of India, Ministry of Health and Family Welfare has published a Gazette Notification GSR no. 604 (E) dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules, thereby introducing a new provision for the registration of the manufacturing premises of foreign drug manufacturer and the

individual drugs prior to their import into the country. The notification has also introduced few other provisions viz. enhanced import licence fees, increased validity period of licence, deletion of exemption from requirement of import licence for bulk drugs for actual users, requirement of minimum 60% of retained shelf life for imported drugs and provisions for import of small quantities of new drugs by Govt. hospitals for treatment of their own patients etc. Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. The applications can be made by authorized agents of foreign firms in India. The documents required for registration certificates have been clearly specified in the amendments. The validity of registration certificates will be 3 years from the date on which these are issued. A fee of 1500 USD is to be charged for the registration of overseas manufacturer's premises and fee of 1000 USD will be charged for every individual drug. The rules provide now for inspection of the premises of a foreign manufacturer by Indian Drug Authorities, whenever so required. In such cases, an additional fee of 5000 USD is to be charged. The rules also provided for payment of testing charges by registration holders. The foreign manufacturer or his authorised agent in India shall be liable to report any change in the manufacturing and testing process of a drug. However, no registration certificate shall be insisted in respect of an inactive bulk substance to be used as pharmaceutical aid for manufacture of drug formulation. The registration may be suspended or cancelled in the event any violation of the conditions for registration comes to notice. The new registration and import licence scheme shall also cover diagnostic kits viz. HIV I & II, HBsAg, HCV and blood group reagents. According to new rules, import licence will be required for all types of drugs instead of existing import licence requirements for Schedule C & C (1) and Schedule X drugs only. Import licence in Form 10 would be granted after completing the registration of overseas manufacturers and their specific drugs to be imported. The import licence for specific drugs will be valid for 3 years from the date on which these are granted. The import licence fee has been kept Rs. 1000/- for a single drug and at the rate of Rs.100/- for additional drug. The fee of import licences for test and analysis of a drug has been kept Rs. 100/- for a single drug and at the rate of Rs. 50/- for each additional drug. The exemption from import licences for the import of bulk drugs by the formulations for actual use under Schedule D has been deleted. A provision has been made that only drugs with minimum 60% of retained shelf life shall be allowed to be imported in the country. A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their owm patients. The fee for such import licences has been kept Rs. 100/- for a single drug and the rate of Rs. 50/- for each additional drug. The notification will come into operation with effect from 1st January 2003. In order to enable a smooth change over the new import requirements, it is proposed that all manufacturers/importers who are to obtain registration certificates for drugs, and import licences in January 2003, should submit their applications for registration certificates on or before 31.3.2002 and import licence applications not later than 30.9.2002, thereby giving minimum lead time to process their applications. Existing import of drugs under Form 10 licences will continue up to 31.12.2002. Since the existing validity of Form 10

Licences extends upto the end of next calendar year, it will be stipulated in Form 10 Licences issued w.e.f. 1.1.2002 that validity of such licences will terminate automatically on 31.12.2002. The new scheme would take care of a long felt need for laying down import registration requirements similar to those adopted by various other countries. The drug and Cosmetic Act and Rules provide for the import of drugs and cosmetics. In general, drugs or cosmetics may be imported into India under the authority of a licence excepting whose import is prohibited. Some drugs and cosmetics can be imported without any permit provided they are of atandered quality and statement that they comply with the provisions relating to import, has been given to the Customs Collector by the manufacture of importer. The term "import" is derived from the conceptual meaning as to bring in the goods and services into the port of a country. The buyer of such goods and services is referred to an "importer" who is based in the country of import whereas the overseas based seller is referred to as an "exporter". Thus an import is any good (e.g. a commodity) or service brought in from one country to another country in a legitimate fashion, typically for use in trade. It is a good that is brought in from another country for sale. Import goods or services are provided to domestic consumers by foreign producers. An import in the receiving country is an export to the sending country. Imports, along with exports, form the basis of international trade. Import of goods normally requires involvement of the customs authorities in both the country of import and the country of export and are often subject to import quotas, tariffs and trade agreements. When the "imports" are the set of goods and services imported, "Imports" also means the economic value of all goods and services that are imported. In this Part:(a) Import licence means a licence in Form 10 to import drugs, excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X. (b) Licensing authority means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22; (c) Licence for examination, test or analysis means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis. (d) Manufacturer includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drug manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and /or in other major countries: (e)Registration Certificate means a certificate issued under rule 27A by the licensing authority in Form- 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.

 QUALITY OF DRUGS: As per drugs & Cosmetics Act quality of drugs are given as follows: STANDARDS OF QUALITY (under Section 8) (1) Standard quality means (a) in relation to a drug, that the drug complies with the standard set out in the Second Schedule, and (b) in relation to a cosmetic, that the cosmetic compiles with such standard as may be prescribed. (2) The Central Government, after consultation with the Board and after giving by notification in the Official Gazette not less than three months notice of its intention so to do, may by a like notification add to or otherwise amend the Second Schedule, for the purpose of this part of the act, and thereupon the Second Schedule shall be deemed to be amended accordingly. MISBRANDED DRUGS (under Section 9) A drug is termed as misbranded; (a) if it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or (b) if it is not labelled in the prescribed manner; or (c) if its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular; Misbranding should, as well, be as such can not be detected by a lay purchaser with the ordinary deligence. A phonetic similarly in two trade mark like Cocogem and Kotogem is not sufficient. There should be reasonable probability of deception. ADULTERATED DRUGS (under Section 9A) A drug is termed as adulterated,-(a) if it consists, in whole or in part, of any filthy, putrid or decomposed substance; or (b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health; or (c) if its container is composed in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or (e) if it contains any harmful or toxic substance which may render it injurious to health; or (f) if any substance has been mixed therewith so as to reduce its quality or strength. SPURIOUS DRUGS (under Section 9B) A drug is termed as spurious (a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or (c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or (d) if it has been substituted wholly or in part by another drug or substance; or (e) if it purports to be the product of a manufacturer of whom it is not truly a product . MISBRANDED COSMETICS (under Section 9C) A cosmetic shall be deemed to be misbranded--(a) if it contains a colour which is not prescribed ; or (b) if it is not labelled in a prescribed manner; or (c) if the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. SPURIOUS COSMETICS (under Section 9D) A drug shall be deemed to be spurious, -(a) if it is imported under the name which belongs to another cosmetic; or (b) if it is an imitation of, or is a substitute for, another cosmetic or resembles another cosmetic in a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic, unless it is plainly or conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or (c) if the label or the container bears the name of an individual or company purporting to be the manufacturer of the cosmetic, which individual or company is fictitious or does not exist; or (d) if it purports to be the product of a manufacturer of whom it is not truly a product. IMPORT OF DRUGS For the purposes of import, which is deemed to be the process of a bringing a material from a place outside India to a place in India. The details of import of drugs can be discussed below: o Classes of drugs whose import is prohibited. o Classes of drugs which may be imported under licence or permit. o Classes of drugs which can be imported without any licence. A. DRUGS WHOSE IMPORT IS PROHIBITED Prohibition Of Import Of Certain Drugs Or Cosmetics: Prohibition of import of certain drugs or cosmetics under section Section 10 of the Act. From such date as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import (a) any drug or cosmetic which is not of standard quality; (b) any misbranded drug or misbranded or spurious cosmetic; (bb) any adulterated or spurious drug;

(c) any drug or cosmetic for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence; (d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it, together with the quantities thereof; (e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed; (ee) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended; (f) any drug or cosmetic the import of which is prohibited by rule made under this act; Nothing in this section shall apply to the import, subject to prescribed conditions, of small quantities of any drug for the purpose of examination, test or analysis or for personal use. The Central Government may, after consultation with the Board (DTAB), by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the import of any drug or class of drugs not being of standard quality. B. IMPORT OF DRUGS UNDER LICENCE The following classes of drugs may be imported under the licence or permission granted by the Licensing Authority-o Drugs specified in schedule C and C1 excluding those specified in schedule X. o Drugs specified in schedule X. o Import of drugs for examination, test or analysis. o Import of drugs for personal use covered by a prescription of Registered Medical Practitioner. o Any new drug. An application for import licence should be made to proper authority in the prescribed form. A licence remains valid up to 31st December of the year in which it is granted, unless earlier suspended or cancelled. Any person who is not satisfied by a suspention or cancellation order passed by the licensing authority may appeal in the High Court. A separate licence is necessary in respect of drugs from each manufacture. A separate import licence is required in respect of drugs manufactured at each premises when a single manufacture abroad has more than one factory situated at different places. Licences for import of drugs manufactured by one manufacturer: A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer. The drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit. If a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of the drugs manufactured by each such factory.

FORM NO. FOR THE GRANT OF VARIOUS IMPORT LICENCE Form 8: Application for licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945. Form 8- Application for licence to import drugs specified in Schedule X to the A: Drugs and Cosmetics Rules, 1945. Form 9: Form of undertaking to accompany an application for an import licence. Form 10: Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetic Rules, 1945. Form 10- Licence to import drugs specified in Schedule X to the Drugs and A: Cosmetic Rules, 1945. Form 11: Licence to import drugs for the purpose of examination, test or analysis. Form 11- Licence to import drugs by a Government Hospital or Autonomous A: Medical Institution for the treatment of patients. Form 12: Application for licence to import drugs for purpose of examination, test or analysis. Form 12- Application for the issue of a permit to import small quantities of A: drugs for personal use. Form12A: Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients. Form 12- Permit for the import of small quantities of drugs for personal use. B: Form 40: Application for issue of Registration Certificate for import of drugs into India under the Drugs and Cosmetics Rules, 1945. Form 41: Registration Certificate to be issued for import of drugs into India under Drugs and Cosmetics Rules, 1945.

I. IMPORT OF SCHEDULE C, C1 AND X DRUGS An import licence is required for the import of any biological or other special products specified in Schedule C, C1 excluding X, and specified in schedule X. In addition to the general conditions for the import licence one special condition for import of schedule C and C1 drugs is that the Licensing Authority must be satisfied that the premises where the imported substances will be stocked by the importer are equipped with proper accommodation for preserving the properties of imported drug. The licencing authority also takes into consideration the occupation, trade or business ordinarily carried out by the importer. The licensee should inform the licensing authority about any change in the constitution of licensed firm. The licence of schedule C and C1 rugs must comply with the undertaking given in Form 9. The import licence is liable to be cancelled or suspended if conditions are not met. Form and Manner of Application for Import Licence

(1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8-A for drugs specified in Schedule X, either by manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these rules, or by the manufacturers agent in India either having a valid licence under the rules to the manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by a licence fee of one hundred rupees for a single drug and an additional fee at the rate of one thousand rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer. In the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug. (2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under rule 27-A. In case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10-A, as the case may be, without the issuance of Registration Certificate under rule 27-A, for reasons to be recorded in writing. (3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this rule, if the original is defaced, damaged or lost. Import Licences The licensing authority may with the approval of the Central Government by an order in writing delegate the power to sign licences and Registration Certificate and such other powers as may be specified in the order to any other person under his control. An import licence in Form 10 shall be required for the import of drugs, excluding those specified in Schedule X, and an import licence in Form 10 A shall be required for the import of drugs specified in Schedule X. Condition to be satisfied before a licence in Form 10 or Form 10-A is granted (1) A licence in Form 10 or in Form 10-A shall be granted by the licensing authority having regard to the premises, where the imported substances will be stocked are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and the occupation, trade or business ordinarily carried out by the applicant. The licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,-that the applicant has not complied with the provisions of the Act or these rules or that by reasons of (i) his conviction under the Act or these rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 or the rules made thereunder. (ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted. (2)Any person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry in to the matter as it considers

(a) (b)

necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit. Conditions of import licence An import licence shall be subject to the following conditions; (i) The manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9; (ii) The licensee shall allow any Inspector authorized by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples; (iii) The licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied. (iv) If the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding subrule until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the licensing authority; (v) The licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed under this Act, or the Rules thereunder and on being directed so to do withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall the issues already made from that batch; (vi) The licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorised in that behalf by the licensing authority; In respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain separate record or register showing the following particulars, namely; Name of the Drug, Batch number, Name and address of the manufacturer, Date of transaction, Opening stock on the business day, Quantity of drug received, if any, and the source from which received, Name of the purchaser, his address and licence number, Balance quantity of drug at the end of the business day, Signature of the person under whose supervision the drugs have been supplied. (vii) The licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any Rules, subsequently made under this part of the act of the Act and of which the licensing authority has given to him not less than four months notice.

1. 2. 3. 4. 5. 6. 7. 8. 9.

Grant of import licence On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 or From 10-A, as the case may be. Duration of import licence A licence unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue. If application for a fresh licence is made 3 months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application. Suspension and Cancellation of Import Licence If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, suspend or cancel it for such period as it thinks fit, either wholly or in respect of some of the substances to which it relates. Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter, as it considers necessary and after giving the said appellant an opportunity for representing his views, pass such orders in relation thereto as it thinks fit. IMPORT OF SMALL QUANTITIES OF DRUGS o Import of drugs for examination, test or analysis. o Import of drugs for personal use. o Import of drugs by a government hospital or autonomous medical institution for the treatment of patient. II. IMPORT OF DRUGS FOR EXAMINATION, TEST OR ANALYSIS Small quantities of drugs the import of which is otherwise prohibited may be imported for the purpose of examination, test or analysis. A licence is necessary for the import of small quantities of drugs for analytical purposes. For which application has to be made to the licensing authority duly signed by the Head of the Institution where the drugs are to be analysed or tested. The issue of the licence is subject to the following conditions:a) Drug can be imported only under a licence in Form 11; b)the licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorize;

c) the licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substance are being used and to take samples thereof; d)the licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer; e) the licensee shall comply with such further requirements, if any applicable to the holders of licences for examination, test or analysis as may be specified in any rules subsequently made under the provision related to import of drugs and cosmetics of this Act and of which the licensing authority has given to him not less than one months notice. Application for licence for examination, test or analysis; (1) An application for a licence for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director or the company or firm by which the examination, test or analysis will be conducted. (2)The licensing authority may require such further particulars to be supplied as he may consider necessary. (3) Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees or each additional drug. (4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210-Medical and Public Health, 04- Public Health, 104Fees and Fines. Licence An import licence for the purpose of examination, test or analysis shall be made in Form 11. Cancellation of licence for examination, test or analysis; (1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued. (2) A licensee whose licence has been cancelled may appeal to the Central Government within 3 months of the date of the order III. IMPORT OF DRUGS FOR PERSONAL USE Small quantities of drugs, the import of which is otherwise prohibited, can be imported for personal use subject to the following conditions: (i) the drugs shall form part of a passengers bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger; (ii) the drugs shall be declared to the Customs authorities if they so direct; (iii) the quantity of any single drug so imported shall not exceed one hundred average Doses.

The licensing authority may in an exceptional case in any individual case sanction the import of a large quantity. Any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:-(i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use; (ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and (iii) the licensing authority grants a permit in respect of the said drug in Form 12B. IV. IMPORT OF NEW DRUG BY A GOVERNMENT HOSPITAL OR AUTONOMOUS MEDICAL INSTITUTION Import of drugs by a government hospital or autonomous medical institution for the treatment of patient; Small quantities of new drug, as defined in rule 122-E, the import of which is otherwise prohibited under this Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:(a) No new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin; (b) The licence shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorize; (c) The licencee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof; (d)The licencee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease; (e) The licencee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under thisct and of which the licensing authority has given to him not less than one months notice;

(f) The drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist; (g) The quantity of any single drug so imported shall not exceed 100 average dosages per patient. Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug a large quantity. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients; An application for an import licence for small quantities of a new drug for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be. The licensing authority may require such further particulars to be supplied, as he may consider necessary. Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug. The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210- Medical and Public Health, 04- Public Health, 104Fees and Fine. Licence: An import licence to import drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients shall be made in Form 11A. Cancellation of licence for import of small quantities of new drugs: A licence for import of small quantities of a new drug, for the purpose of the treatment of patients suffering from life threating diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder. A licencee whose licence has been cancelled may appeal to the Central Governmentn within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit. V. IMPORT OF NEW DRUGS Drugs whose composition is not recognized as safe or used by experts and not been used widely for any appreciable period of t5ime and regarded as new drugs. Permission for the import of these may be obtained after giving the detailed of the standards of quality,

purity and strength etc. should be supplied to the licencing authority as provided in Schedule Y. C. IMPORT OF DRUGS WITHOUT LICENCE OR PERMISSION Drugs, excepting those discussed above, may be imported without any permit or licence. However, before such drugs are imported into the country, their importers or manufacturers should submit a declaration to the Customs Collector that they comply with all the provisions of Chapter III (Provisions related to the Import of Drugs and Cosmetics) of this Act and Rules made under the same. PROCEDURE FOR THE IMPORT OF DRUGS (1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions related to the import of the drugs and Rules thereunder he may, and if requested by an officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the Director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the Director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government, on such samples is received. Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall make over the consignment to the importer. (2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required by the Customs Collector to return the consignment or any portion thereof he shall return the consignment or portion thereof within ten days of receipt of the notice. (3) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government, reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Import of Drugs and Cosmetics of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall cause them to be destroyed. Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs Collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final. (4) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Import of Drugs and Cosmetics of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer

and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorized in this behalf by the Central Government. OTHER PROVISIONS REGARDING IMPORT OF DRUGS I. STANDARD FOR CERTAIN IMPORTED DRUGS No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall be applicable for determining whether any such imported drug complies with the said standard. The drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F1 and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F1 for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary. That the licensing authority shall not allow the import of any drug having less than sixty percent residual shelf-life period as on the date of import. Provided that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow, the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug. II. PLACE THROUGH WHICH DRUGS MAY BE IMPORTED INTO INDIA No drug shall be imported into India except through one of the following places, namely: (under Section 43A). 1.Freozepore Cantonment and Amritsar Railway Stations: In respect of drugs imported by rail across the frontier with Pakistan. 2. Ranaghat, Bongaon and Mohiassan Railways Stations: In respect of drugs imported by rail across the frontier with Bangladesh. 3. Raxaul: In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal. 4. Chennai, Kolkata, Mumbai and Cochin, Nhava Sheva and Kandla: In respect of drugs imported by sea into India. 5. Chennai, Kolkata, Mumbai, Delhi, Ahemdabad and Hyderabad: In respect of drugs imported by air into India. Consignments of drugs in transit through India to foreign countries and which are not intended to be sold or distributed in India are exempted from the provisions regulating the import of drugs. However, if the consignments are covered by import licences granted by countries of destination, the importer has to produce such licences at the time of import. III. POWER OF CENTRAL GOVERNMENT TO PROHIBIT IMPORT OF DRUGS AND COSMETICS IN PUBLIC INTEREST- (under Section 10A)

If the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the import of such drug or cosmetic. IV. APPLICATION OF LAW RELATING TO SEA CUSTOMS AND POWERS OF CUSTOMS OFFICERS (under Section-11) The law for the time being in force relating to sea customs and to goods, the import of which is prohibited by section 18 of the Sea Customs Act, 1878 shall, subject to the provisions of section 13 of this Act, apply in respect of drugs and cosmetics the import of which is prohibited under this act, and officers of Customs and officers empowered under that Act to perform the duties imposed thereby on a Customs Collector and other officers of Customs, shall have the same powers in respect of such drugs and cosmetics as they have for the time being in respect of such goods as aforesaid. The Customs Collector or any other officer of the Government authorized by the Central Government in this behalf, may detain any imported package which he suspects to contain any drug or cosmetic the import of which is prohibited under this act and shall forthwith report such detention to the Drugs Controller, India, and, if necessary, forward the package or sample of any suspected drug or cosmetic found therein to the Central Drugs Laboratory for analysis. V. PROHIBITION OF IMPORT AFTER EXPIRY OF POTENCY No biological or other special product specified in Schedule C or C (1) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test. VI. PROHIBITION OF IMPORT OF CERTAIN DRUGS No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis. OFFENCES AND PANELTIES (1) Whoever himself or by any other person on his behalf imports,(a) any drug deemed to be adulterated or deemed to be a spurious drug or any spurious cosmetic or any cosmetic of the nature shall be punishable with imprisonment for a term which may extend to 3 years and a fine which extend to five thousand rupees (5,000 Rs.); (b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the import of which is prohibited, or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to 6 months, or with fine which extend to five thousand rupees (5,000 Rs.) or both; (c) any drug or cosmetic in contravention of the provision of any notification issued, shall be punishable with imprisonment for a term which may extend to 3 years, or with fine which extend to five thousand rupees (5,000 Rs.), or both;

(2) Whoever having been convicted of an offence (a) under clause (a) or clause (c) of sub-section (1), is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to ten thousand rupees(10,000 Rs.), or with both; (b) under clause (b) of sub-section (1),is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees, or with both (3) The punishment provided by this section shall be in addition to any penalty to which the offender may be liable under the provision of section 11. MISCELLANEOUS PROVISIONS RELATED TO THE IMPORT OF DRUGS I. Drugs Exempted from Import Provisions The drugs specified in Schedule D are exempted from the provisions related to Import of drugs. II. Confiscation Where any offence punishable has been committed, the consignment of the drugs or cosmetics in respect of which the offence has been committed shall be liable to confiscation. III. Consignments Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of provision related to the import of the drugs of the Drugs and Cosmetics Act, 1940 and the rules made thereunder. Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences. IV. Confiscation of drugs, implements, machinery etc. Where any person has been convicted for contravening any of the provisions related to the manufacture, sale and distribution of drugs and cosmetics (Chapter IV) of the Act or any rule made thereunder, the stock of the drug in respect of which the contravention has been made shall be liable to confiscation. Where any person has been convicted for the manufacture of any drug deemed to be misbranded under this Act, or adulterated drug under this Act, or for manufacture for sale, or stocking or exhibiting for sale or distribution of any drug without a valid licence as required under the Act, any implements or machinery used in such manufacture, sale or distribution and any receptacle, packages, or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation. V. Procedure for disposal of confiscated drugs The Court shall refer the confiscated drugs to the Inspector concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the Rules

in any respect. If the Inspector, on the basis of Government Analysts report finds the confiscated drugs to be not of standard quality or to contravene any of the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. The Court shall thereupon order the destruction of the drugs. The destruction shall take place under the supervision of the Inspector in the presence of such authority, if any, as may be specified by the Court. If the Inspector finds that the confiscated drugs are of standard quality and do not contravene the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. The Court may then order the Inspector to give the stocks of confiscated drugs to hospital or dispensary maintained or supported by the Government or by Charitable Institution. VI. Power of Central Government to make rules The Central Government may, after consultation with or on the recommendation of the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Act. Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS Manufacturing is the use of machines, tools and labor to make things for use or sale. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be used for manufacturing other, more complex products, such as household appliances or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users - the "consumers". "Manufacturing" means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by large volume extraction from substances of natural origin, or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of a substance or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices. "Manufacturing" also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacists to anyone other than a patient via a prescription, practitioners, or other persons. "Manufacture" in relation to any drug, includes any process or part of a process for making, altering, finishing, packing, labeling, breaking or otherwise treating or adapting any drug with a view its sale and distribution, but does not include the compounding or dispensing of any drug or the packing of any drug in the ordinary course of retail business, and "to manufacture" shall be construed accordingly. "Manufacturer" means any person who manufactures a drug.

Following licence are granted for the manufacturing of drugs under the D & C Act and rules thereunder: o Drugs other than those specified in Schedules C and C (1). o Drugs specified in Schedule X not specified in Schedules C and C (1). o Drugs specified in Schedule C, C1 excluding those specified in Schedule X. o Drugs specified in Schedules C, CI & X. o Manufacture of large volume parenterals/sera and vaccines specified in Schedules C. and C (I) excluding those specified in Schedule X. o Drugs for the purpose of examination, test or analysis. o Loan Licence; Drugs other than those specified in Schedules C and C (1). Drugs specified in Schedules C and C (1). o Repacking Licence; Drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X. o Licence to manufacture of whole human blood & components for sale or distribution; Licence to operate a Blood Bank for collection, storage and processing of whole human blood and/or its components for sale or distribution. Licence to manufacture and store blood products for sale or distribtion. o Any new drugs If drugs are manufactured on more than one set of premises, separate licences are required in respect of each such set of premises. There are two types of conditions which are required to be satisfied for all manufacturing licence, Conditions which are required to be satisfied before a licence is granted (Conditions precedent) and conditions which are required to be satisfied after the grant of licence (Conditions subsequent). MANUFACTURE APPLICATIONS, LICENCES, FEES AND PENALTY

Licenc Fees for Category of Application e S.No. Grant / drugs Form No. Form Renewal No. Drugs other than those specified in Schedule 24-B upto C&C (1)& 10 items for 25-B excluding each those category specified in X (i)Repacking of drugs (ii)Drugs specified in Schedule X 24-F upto 10 items for 25-F each category

Fee for addl. Item for Fee+ Penalty after more than expiry but within 10 item for six months each category

1.

Lic. Fees of Rs.500+Insp. Rs.500+Rs.250p.m. Fee of Rs. 200 or part thereof in Rs.100 for for every addition to an each addl. inspection or for inspection fee of Rs. item, renewal of 200 licence R-69(2) (a) Lic. Fee of Rs. 6000+ Insp. Fee Rs.6000+Rs.1000 of Rs.1500 for p.m. or part thereof Rs.300 per every inspection in addition to insp. item or for renewal ofFee of Rs. 1000. licence. R: 69(2)(b) Lic. Fee of Rs. 6000+ Insp. Fee Rs.6000+Rs.1000 of Rs.1500 for p.m. or part thereof Rs.300 per every inspection in addition to insp. item or for renewal ofFee of Rs. 1500. licence. R: 69(2)(c)

(iii) Any other drugs (drugs other 24 upto 10 than those items for 25 specified in each Schedules C category and C(1))

(iv) Loan Lic. Fee of Rs. Licence 24-A upto 6000+ Insp. Fee Rs.6000+Rs.1000 (drugs other 10 items for of Rs.1500 for p.m. or part thereof Rs.300 per than those 25-A each every inspection in addition to insp. item specified in category or for renewal ofFee of Rs. 1500. Schedules C licence. and C (1)) R: 69A(1) Drugs specified in Schedule 27 upto 10 C&C (1) items for excluding 28 each those category specified in Sch.X (i)Own unit (ii) Loan Licence 27-A upto drugs 10 items for 28-A specified in each Schedules C category and C (1)

2.

Lic. Fee of Rs. 6000+ Insp. Fee Rs.6000+Rs.1000 of Rs.1500 for p.m. or part thereof Rs.300 per every inspection in addition to insp. item, or for renewal ofFee of Rs. 1500. licence. R: 75(1) Lic. Fee of Rs. 6000+ Insp. Fee Rs.6000+Rs.1000 of Rs.1500 for p.m. or part thereof Rs.300 per every inspection in addition to insp. item or for renewal ofFee of Rs. 1500. licence. R: 75A(1)

 PROHIBITION OF MANUFACTURE AND SALE Prohibition of manufacture and sale of certain drugs and cosmetics; From such date as may be fixed by the State Government by notification in the Official Gazette in this behalf, no person shall himself or by any other person on his behalf (a) Manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale (i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious; (iii) any cosmetic which is not of a standard quality or is misbranded or spurious; (iv)any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof; (v) any drug which by means of any statement, design or device accompanying it or by any other means ,purport or claims to prevent ,cure or mitigate any such disease or ailment ,or to have any such other effect as may be prescribed; (vi)any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended; (vii) any drug or cosmetic in contravention of any of the provisions of this Chapter or any rule made thereunder; (b) Sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic which has been imported or manufactured in contravention of any of the provisions of this Act or any rule made thereunder; (c) Manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosmetic, except under, and in accordance with the conditions of, a licence issued for such purpose under this Act. Nothing in this section shall apply to the manufacture, subject to prescribed condition of small quantities of any drug for the purpose of examination, test or analysis. The Central Government may, after consultation with the Board, by notification in the Official Gazette, permit, subject to any conditions specified in the notification, the manufacture for sale, or for distribution, sale, stocking or exhibiting or offering for sale or distribution of any drug or class of drugs not being of standard quality. MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF DRUGS Manufacture on more than one set of premises; If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises. Grant or Renewal of Licences by the Central Licence Approving Authority; (1) Notwithstanding anything contained in this part, on and from the commencement of the Drugs and Cosmetics (Ninth Amendment) Rules.1992, a licence for the manufacture for sale or distribution of drugs as specified from time to time by the Central Government by notification in the Official Gazette, for the purpose of this rule, shall be granted or renewed, as the case maybe, by the Central Licence Approving Authority (appointed by the Central Government. Provided that the application for the grant or renewal of such licence shall be made to the licensing Authority.

(2) On receipt of the application for grant or renewal of a licence, the licensing authority shall,-(i) verify the statement made in the application Form; (ii) cause the manufacturing and testing establishment to be inspected in accordance with the provisions of rule 79; and (iii) in case the application is for the renewal of licence, call for the informations of the past performance of the licensee. (3) If the licensing authority is satisfied that the applicant is in a position to fulfill the requirements laid down as in these rules, he shall prepare a report to that effect and forward it along with the application and the licence (in triplicate) to be granted and renewed , duly completed to the Central Licence Approving Authority. If the licensing authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence as the case may be. (4) If on receipt of the application and the report of the licensing authority referred to in subrule-(3) and after taking such measures including inspection of the premises by the Inspector,appointed by the Central Government under section 21 of the Act, with or without an expert in the concerned field if deemed necessary, the Central Licence Approving Authority, is satisfied that the applicant is in a position to fulfill the requirements laid down in these rules, he may grant or renew the licence, as the case may be. If the Central Licence Approving Authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules, he may, not withstanding the report of the licensing authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of licence as the case may be. I. MANUFACTURE OF DRUGS OTHER THAN THOSE SPECIFIED IN SCHEDULES C AND C (1) AND MANUFACTURE OF DRUGS SPECIFIED IN SCHEDULE X AND NOT SPECIFIED IN SCHEDULES C AND C (1) Application for the grant or renewal of licence for the manufacture of drugs other than those specified in Schedule C, C1 and X should be made to the licensing authority in Form 24 and for the manufacture of drugs specified in Schedule X but not specified in Schedule C and C1 in Form 24F. The Respective Licence shall be issued in Form 25 and 25F. Application For Licences Application for licence to manufacture drugs other than those specified in Schedules C and C (1) to the Drugs and Cosmetics Rules--(1) Application for grant or renewal of licence to manufacture for sale or for distribution of drugs, other than those specified in Schedule C and C (1) shall be made to the licensing authority appointed by the State Government for the purpose of this part and shall be made-in the case of manufacture of drugs included in Schedule X in Form 24-F; in any other case, in Form 24.

a)

b)

(2) (a) Every application in Form 24F shall be made up to ten items for each category of drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every subsequent inspection or for the purpose of renewal of licence. (b) Every application in Form 24 shall be made up to ten items for each category of drugs catogarised in Schedule M and Schedule M-III and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of one thousand and five hundred for every inspection or for the purpose of renewal of the licence; (3) If a person applies for the renewal of a licence after the expiry thereof but within 6 months of such expiry the fee payable for the renewal of such licence shall be:-(i) in the case of Form 24-F a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand; (ii) in the case of Form 24 a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand and five hundred; (4) A fee rupees one thousand shall be paid for a duplicate copy of the licence issued, if the original is defaced, damaged or lost. (5) Applications by licensees to manufacture additional items of drugs shall, in the case of a licence to manufacture for sale and distribution for repacking and other than those specified in Schedule C and Schedule C (1), be made to the licensing Authority. Such applications shall, if the additional items of drugs applied for belong to categories which are not already included in the licence, be accompanied by an additional fee at the rate of rupees one hundred for each additional items of drug for repacking and rupees three hundred per additional item of drugs categorized in Schedule M and Schedule M-III. (6) Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drug, such application shall also be accompanied with approval, in writing in favour of the applicant, from the licensing authority. Form of Licences:A licence for the grant or renewal of licence for the manufacture of drugs other than those specified in Schedule C, C1 and X shall be issued in Form 25 and for the manufacture of drugs not specified in Schedule C and C1 but specified in Schedule X in Form 25F. Conditions for the grant or renewal of a licence; Before a licence in Form 25 or Form 25-F is granted or renewed, the following conditions shall be complied with by the applicant.(1)The manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a wholetime employee and who is____ (a) a graduate in Pharmacy or Pharmaceutical Chemistry of a University established in India by law or have an equivalent qualification recognized and notified by the Central Government for such purpose of this rule and has had at least eighteen months practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has

undergone training in manufacture of drugs for a period of six months during his University course; or (b) a graduate in Science of a University established in India by law or have an equivalent qualification recognized and notified by the Central Government for such purpose of his degree has studied Chemistry as a principal subject and has had at least three years practical experience in the manufacture of drugs after his graduation; or (c) a graduate in Chemical Engineering or Chemical Technology or Medicine of a University established in India by law or have an equivalent qualification recognized and notified by the Central Government for such purpose with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or (d) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b) or clause (c) and is permitted to work as competent technical staff under this rule by the Central Government. Any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any licence granted in Form 25 or Form 25-F as it existed before the date shall be deemed to be qualified for the purposes of this rule. Provided further that for drugs other than those specified in Schedule C, C(1) and X and meant for veterinary use, the whole-time employee under whose supervision the manufacture is conducted shall be graduate in veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years practical experience in the manufacture of drugs excluding graduate in Pharmacy who shall have at least eighteen months practical experience in the manufacture of drugs. Provided also that the Licensing Authority may, in the matter of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non chemical contraceptives, plaster of Paris and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included in clauses (a), (b) or (c) of this rule, has, in the opinion of the Licensing Authority, adequate experience in the manufacture of such substance. (2)The factory premises shall comply with the conditions prescribed in Schedule M. (3)The applicant shall provide adequate space, plant and equipment for the manufacturing operations; the space, plant and equipment recommended for various operations are given in Schedule M. (4)The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit, which shall be separate from the manufacturing unit and the head of the testing unit shall be independent of the head of the manufacturing unit. The manufacturing units, which, before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions

approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements upto the 30th June, 1977. Provided that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it under Part XV (A) of these rules for this purpose. (4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate. (5)The applicant shall make adequate arrangements for the storage of drugs manufactured by him. (6)The applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines____ (i) contain the constituent ingredients in therapeutic / prephylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful; (ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation and under the conditions in which the ormulation for administration and use are recommended; (iii) are stable under the conditions of storage recommended; and (iv)contain such ingredients and in such quantities for which there is therapeutic ustification. (v) have the approval, in writing, in favour of the applicant to manufacture drugs formulations falling under the purview of new drug, from the Licensing Authority. (7) The licensee shall comply with the requirements of Good Manufacturing practices as laid down in Schedule M. Conditions of licence: A licence in Form 25 and Form 25-F shall be subject to the conditions stated therein and to the following further conditions, namely: ____ (a) the licensee shall provide and maintain staff, premises and the equipment as specified in rule 71; (b) the licensee shall comply with the provisions of the Act and of these Rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the rules, these would come into force, four months after publication in the official Gazette; (c) the license shall either in his own laboratory or in any other laboratory approved by the Licensing Authority under Part XV (A) of these rules test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of 5 years from the date of manufacture;

(d) the licensee shall keep records of the details of manufacture as per particulars given in Schedule U of each batch of the drugs manufactured by him and such records shall be retained for a period of 5 years; (e) the licensee shall allow an Inspector appointed under the Act, to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture and the means employed in standardizing and testing the drugs; (f) the licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules thereunder have been observed; (g) the licensee shall, from time to time, report to the Licensing Authority any changes in the expect staff responsible for the manufacture or testing of the drugs and any material alterations in the premises or plant used for the purpose which have been made since the date of the last inspection made on behalf of the licensing authority; (h) the licensee shall, on request, furnish to the Licensing Authority, the Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct from every batch, or batches of drugs as the Licensing Authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of tests which have been applied; (i) if the Licensing Authority or the Controlling Authority so directs and if requested by the licensee who had also furnished prima facie reason for such directions, the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under clause (h) until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the Licensing Authority or the Controlling Authority; (j) the licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch of the drug has been found by the Licensing Authority or the Controlling Authority not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already from that batch; (k) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed; (l) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture. (m) The licensee, who has been granted a licence in Form 25-F, shall(i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing-homes and Registered Medical Practitioners every three months;

1. 2. 3. 4. 5. 6. 7. 1. 2. 3. 4. 5. 6. 7. 8. 1. 2. 3. 4. 5. 6. 7. 8. 9.

(ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of 5 years or one year after the expiry of potency, whichever is later:A. Accounts of the drugs specified in Schedule X used for the manufacture:Date of issue Name of the drug Opening balance of stock on the production day. Quantity received, if any, and source from where received. Quantity used in manufacture. Balance quantity on hand at the end of the production day. Signature of the person in charge. B. Accounts of production:Date of manufacture, Name of the drug, Batch Number Quantity of raw material used in manufacture. Anticipated yield. Actual yield, Wastage, Quantity of the manufactured goods transferred. C. Accounts of the manufactured drugs:Date of manufacture, Name of the drug, Batch Number, Opening Balance, Quantity manufactured, Quantity sold, Name of the purchaser and his address, Balance quantity at the end of the day, Signature of the person in charge. (n) The licensee shall store drugs specified in Schedule X in bulk from and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person. (o) The licensee shall comply with the requirements of Good Manufacturing Practices as laid down in Schedule M. II. MANUFACTURE OF DRUGS SPECIFIED IN SCHEDULE C, C1 EXCLUDING THOSE SPECIFIED IN SCHEDULE X AND MANUFACTURE OF DRUGS SPECIFIED IN SCHEDULES C, CI & X AND MANUFACTURE OF LARGE VOLUME PARENTERALS/SERA AND VACCINES SPECIFIED IN SCHEDULES C AND C (I) EXCLUDING THOSE SPECIFIED IN SCHEDULE X Application for the licence the licence to manufacture drugs specified in Schedule C, C1 excluding those specified in schedule X should be made to the licensing authority in Form-27 and for drugs specified in schedule C, C1 and X in Form 27B. Application to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccines

shall be issued in Form 27-D. The Respective Licence shall be issued in Form 27 and 27B and Form 27-D. Form of Application for Licences Form of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C (1) and X; (1) Applications for the grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C and C(1) excluding those specified in Schedule X, shall be made to the Licensing Authority in Form 27 and shall be made upto 10 items for each category of drugs catagorised in Schedule M and Schedule M-III and shall be accompanied by a licence of rupees six thousand and an inspection of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licence. (2)Application for grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C, C (1) and X shall be made to the licensing authority in Form 27-B, and shall be made up to 10 items for each category of drugs categorized in Schedule M and Schedule M-III and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purpose of renewal of licences. (3) The application for grant or renewal of licence to manufacture for sale or for distribution of drugs in Large Volume Parenterals and Sera and Vaccines shall be made to the licensing authority appointed under this Part in Form 27-D and shall be made up to 10 items for each category of drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purposes of renewal of licences: If the application for renewal of these licences are made after its expiry but within 6 months of such expiry, the fee payable for renewal of the licence shall be rupees six thousand plus an additional fee of one thousand per month or a part thereof in addition to the inspection fee of rupees one thousand and five hundred. (4) A fee of rupees one thousand shall be paid for duplicate copy of the licence issued if the original licence is defaced, damaged or lost. (5) If the licence applies for manufacture of more than 10 items of each category of drugs, the application shall be accompanied by an additional fee at the rate of rupees three hundred (300 Rs.) for each additional item of drugs categorized in Schedule M and Schedule M-III. (6) Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drugs, such application shall also be accompanied with approval, in writing, in favour of the applicant, from the licensing authority. Form of Licence A licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) (other than Large Volume Parenterals, Sera and Vaccines), drugs specified in Part X-B and Schedule X shall be issued in Form 28 and a licence to manufacture for sale or distribution of drugs specified under Schedules C and C (1) (other than Large Volume Parenterals, Sera and Vaccines, drugs specified in Part XB) and Schedule X shall be issued in Form 28-B. A licence to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccines shall be issued in Form 28-D.

The Conditions for the Grant or Renewal of Such Licences Before a licence in Form 28 or Form 28-B or Form 28-D is granted or renewed, the following conditions shall be complied with by the applicant:(1) The manufacture will be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole time employee and who is____ (a) a graduate in Pharmacy or Pharmaceutical Chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose of this rule and has had at least eighteen months practical experience after the graduation in the manufacture of drugs to which this licence applies; this period of experience may however be reduced by six months if the person has undergone training in manufacture of drugs to which the licence applies for a period of six months during his University course; or (b) a graduate in Science of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose of his degree has studied Chemistry or Microbiology as a principal subject and has had at least three years practical experience in the manufacture of drugs to which this licence applies after his graduation; or (c) a graduate in Medicine of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose with at least three years experience in the manufacture and pharmacological testing of biological products after his graduation; or (d) a graduate in Chemical Engineering of a University recognized by the Central Government with at least three years practical experience in the manufacture of drugs to which this licence applies after his graduation; or (e) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b), clause (c) or clause (d) and is permitted to work as competent technical staff under this rule by the Central Government. Any person who was approved by the licensing authority as an expert responsible for the manufacture of drugs for the purpose of rule 76 read with rule 78 as these rules were in force immediately before the 29th June, 1957, shall be deemed to be qualified for the purposes of this rule. For the drugs specified in Schedules C and C (1) meant for veterinary use, the whole time employee under whose supervision the manufacture is conducted may be a graduate in Veterinary Science or general science or medicine or pharmacy of a University, recognized by the Central Government and who has had at least three years experience in the manufacture of biological products. Provided also that for the medical devices specified in Schedule C, the whole time employee under whose supervision the manufacture is conducted may be a Graduate in Science with Physics or Chemistry or Microbiology as one of the subjects; or graduate in

Pharmacy; or Degree/Diploma holder in Mechanical or chemical or Plastic Engineering of a University recognized by the Central government for such purposes. (2) The factory premises shall comply with the conditions prescribed in Schedule M and Schedule M-III in respect of medical devices. (3) The applicant shall provide adequate space, plant and equipment for any or all the manufacturing operations; the space, plant and equipment recommended for various operations are given in Schedule M and Schedule M-III. (4)The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out such tests of the strength, quality and purity of the substances as may be required to be carried out by him under the provisions of Part X of these rules including proper housing for animals used for the purposes of such tests, the testing unit being separate from the manufacturing unit and the head of the testing unit being independent of the head of the manufacturing unit. The manufacturing units which before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements upto the 30th June, 1977. For tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it under Part XV (A) of these rules for this purpose. (4-A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the Licensing authority is considered adequate. (5) The applicant shall make adequate arrangements for the storage of drugs manufactured by him. (6)The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be printed on the labels of such drugs on the basis of the data so furnished. (7)The applicant shall, while applying for licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines :____ (i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful; (ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended; (iii) are stable under the conditions or storage recommended; and (iv)contain such ingredients and in such quantities for which there is therapeutic justification. (v) have the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug, from the licensing authority. (8) The licensee shall comply, with the requirements of Good Manufacturing Practices as laid down in Schedule M.

Conditions of Licences A licence in Form 28, Form 28-B or form 28-D shall be subject to the special conditions, if any, set out in Schedule F or Schedule F(1), as the case may be, which relate to the substance in respect of which the licence is granted and to the following general conditions(a) (i) The licence shall provided and maintain an adequate staff and adequate premises and plant for the proper manufacture and storage of the substances in respect of which the licence is issued; (ii) Without prejudice to the generality of the foregoing requirement, every holder of a licence who for any purpose engaged in the culture or manipulation of pathogenic sporebearing micro-organisms shall provide to the satisfaction of the Licensing Authority separate laboratories and utensils and apparatus required for the culture or manipulation of such micro-organisms, the laboratories, utensils and apparatus so provided not being used for the manufacture of any other substance; (b) The licensee shall provide and maintain staff, premises and equipment; (c) (i) The licensee shall maintain records of manufacture as per particulars given in Schedule U. (ii) The licensee shall either in his own laboratory or in any laboratory approved by the Licensing Authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained in the case of a substance for which a potency date is fixed for a period of 2 years from the expiry of such date, and in the case of other substances for a period of five years from the date of manufacture. (d) The licensee shall allow an Inspector appointed under the Act to enter, with or without prior notice, any premises where the manufacture is carried on and to inspect the premises, and in the case of substances specified in Schedules C and C (1), to inspect the plant and the process of manufacture and the means employed for standardizing and testing the substance; (e) The licensee shall allow an Inspector appointed under the Act, to inspect all registers and records maintained under these rules and to take samples of the manufactured product and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed; (f) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the substance and any material alterations in the premises or plant used for that purpose which have been made since the date of the last inspection made on behalf of the Licensing Authority before the issue of the licence; (g) the licensee shall on request furnish to the Licensing Authority, Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct, from every batch of drug as the licensing authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish, full protocols of the tests which have been applied.

(h) If the Licensing Authority or the Controlling Authority so directs, the licensee shall not sell or offer for sale any batch in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the Licensing Authority or the Controlling Authority. (i) The licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch of the substance has been found by the Licensing Authority or the Controlling Authority not to conform with the standards of strength, quality or purity specified in these Rules and on being directed so to do, withdraw the remainder of that batch from sale and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch; (j) No drug manufactured under the licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture; (k) The licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette. (l) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and defects noticed. (m) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry is specified on the label the reference samples shall be maintained for a period of three years from the date of manufacture. (n)The licensee, who has been granted a license in Form 28-B shall(i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months (ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later:A. Accounts of the drugs specified in Schedule X used for the manufacture:1. Date of issue, 2. Name of the drug, 3. Opening balance of stock on the production day, 4. Quantity received, if any, and source from where received, 5. Quantity used in manufacture, 6. Balance quantity on hand at the end of the production day, 7. Signature of the person in charge. B. Accounts of Production.:1. Date of manufacture, 2. Name of the drug, 3. Batch Number, 4. Quantity of raw material used in manufacture, 5. Anticipated yield, 6. Actual yield, 7. Wastage, 8. Quantity of the manufactured goods transferred, C. Accounts of the manufactured drugs:-

1. Date of manufacture, 2. Name of the drug, 3. Batch Number, 4. Opening Balance, 5. Quantity manufactured, 6. Quantity sold, 7. Name of the purchaser and his address, 8. Balance quantity at the end of the day, (o) The licensee shall store drugs specified in Schedule X in bulk from and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person. (p) The licensee shall comply with the requirements of Good Manufacturing Practices as laid down in Schedule M. Duration of Licence An original licence in Form 28, Form 28-B and form 28-D or renewed licence in forms 26, 26-F, and Form 26-H or a renewed licence in Form 26, unless sooner suspended or cancelled shall be valid for a period of 5 years on and from the date on which it is granted or renewed. If the application for the renewal of a licence is made before its expiry, or if the application is made within 6 months of its expiry after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within 6 months of its expiry. III. MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS Manufacture of Drugs for the purpose of examination, test or analysis: A licence is required to the manufacture of any drug in small quantity for the purpose of examination, test or analysis. If a person proposing to manufacture does not hold a licence to manufacture drugs specified in schedule C and C1 or to manufacture drugs other than those specified in Schedule C, C1 and X, he shall obtain a licence in Form 29 before commencing such manufacture. In case of drugs not specified as safe for use, a licence in form 29 can be granted only on producing a no objection certificate from the licencing authority appointed by the Central Government. Application should be made by or countersigned by the head of institution or director of the firm or company which proposes to undertake manufacture. The licence remains valid for periods of one year at a time. Any drug manufactured for the purpose of examination, test or analysis shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. If any drug manufactured for the purpose of examination, test or analysis is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the substance if known, or if not known a reference which will enable the substance to the identified and the purpose for which it has been manufactured. The provisions related to the Prohibition of manufacture and sale of certain drugs and cosmetics (under Section 18) of the Act shall not apply to the manufacture of any drug in small quantities for the purpose of examination, test or analysis if the conditions prescribed in this Part are fulfilled. Form of application An application for a licence in Form 29 shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereafter in this Part

referred to as the Licensing Authority) in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured. Every application in Form 29 shall be accompanied by a fee of rupees two hundred fifty (250 rupees). Form of Licence If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29. In the case of a drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the Licensing Authority mentioned in rule 21, to the effect that there would be no objection to such licence being granted. Duration of licence A licence in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time. Conditions of licence A licence in Form 29 shall be subject to the following conditions____ (a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence; (b) the licensee shall allow any 1Inspector appointed under the Act to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted; (c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied; (d) the licensee shall comply with such further requirements, if any, applicable to the holders of licences in Form 29 as may be specified in any Rules subsequently made under the Act and of which the Licensing Authority has given him not less than one months notice; (e) the licensee shall maintain an Inspection Book to enable an Inspector to record his impressions and defects noticed. Cancellation of licences The Licensing Authority may after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the persons therefore, cancel a licence issued under this Part, either wholly or in respect of some of the substances to which it relates, if, in his opinion, the licensee has failed to comply any of the conditions of the licence or with any provisions of the Act or Rules thereunder. A licensee whose licence has been suspended or cancelled may appeal to the State Government within three months of the date of the order.

o o

IV. LOAN LICENCE A loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25. For the purpose of issuing Loan Licences to manufacture for sale or for distribution of drugs are divided in to following categories:Drugs other than those specified in Schedules C and C (1) the licence shall be issued in Form 25-A. Drugs specified in Schedules C and C (1) the licence shall be issued in Form 28-A. A. DRUGS OTHER THAN THOSE SPECIFIED IN SCHEDULES C AND C (1) There are provisions in the Act for the grant of licence for the manufacture of drugs to applicant who do not have their own arrangements for the manufacture of drugs, who wish to avail of the facilities existing with another person licenced to manufacture drugs. Loan licences are issued for the manufacture for sale or distribution of drugs other than those specified in Schedule C,C1 & X. Application for grant or renewal of such loan licence shall be made in Form 24-A and the licence shall be issued in Form 25-A. Application for the Grant or Renewal of Loan Licences; (1) Application for the grant or renewal of loan licences to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C (1) and Schedule X shall be made up to ten items for each category of drugs categorised in Schedule M and Schedule M-111 and shall be made in Form 24-A accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority. If the applicant applies for the renewal of a licence after, its expiry but within 6 months of such expiry, the fee payable for renewal of such licence shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or part thereof. (2) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence. (3) subject to the provisions of sub-rule (2), application for manufacture of more than ten items for each category of drug on a loan licence shall be accompanied by an addition fee of rupees three hundred per additional item specified in Schedule M and Schedule M-111 (4)If the Licensing Authority is satisfied that a loan licence is defaced, damaged or lost or otherwise rendered useless, he may, on payment of a fee of rupees one thousand issue a duplicate licence. Conditions for the Grant of Renewal of A Licence in Form 25-A; A loan licence to manufacture for sale or for distribution or drugs other than those specified in Schedules C, C(1) and X shall be issued in Form 25-A. Before a licence in form 25-A is granted or renewed, the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and date justifying that the patent or proprietary medicines:

(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful; (ii) are safe for use in the context of the vehicles, recipients, additives and pharmaceutical aids used in the formulations and under conditions in which the formulations for administration and use are recommended; (iii) are stable under the conditions of storage recommended; and (iv)contain such ingredients and in such quantities for which there is therapeutic justification. Conditions of Licence in Form 25-A (1) The licence in Form 25-A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25, whose manufacturing facilities have been availed of by the licensee, is cancelled or suspended, as the case may be, under these rules. (2)The licensee shall comply with the provisions of the Act and of these Rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette. (3)The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed. (4) The licensee shall either(i) provide and maintain to the satisfaction of the Licensing Authority adequate staff and adequate laboratory facilities for carrying out test of the strength, quality and purity of the substances manufactured by him or (ii) make arrangements with some institution approved by the Licensing Authority under Part XV (A) of these rules for such tests to be regularly carried out on his behalf by the institution. (5) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture. (6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed. B. DRUGS SPECIFIED IN SCHEDULES C AND C (1)

Loan Licence to manufacture for sale or for distribution of drugs specified in Schedules C and C (1) shall be issued in Form 28-A. Application for the Grant or Renewal of Loan Licences; (1) Applications for the grant or renewal of loan licences for the manufacture for sale or for distribution of drugs specified in Schedules C and C(1) excluding those specified in Part X-B and Schedule X shall be made in Form 27-A to the licensing authority and shall be made upto ten items for each category of drugs categorized in Schedule M and Schedule M-III and shall be accompanied by a fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences. If the applicant applies for the renewal of a licence after its expiry but within 6 months of such expiry the fee payable for renewal of the licence shall be rupees six thousand and an inspection of fee of rupees one thousand five hundred plus an additional fee at the rate of rupees one thousand per month or a part thereof. For the purpose of this rule a loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee in Form 28. (2) The licensing authority, shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, and capacity for manufacture and facilities for testing to undertake the manufacture on behalf of the applicant for a loan licence. (3) Subject to the provisions of sub-rule (2), the application for manufacture of more than 10 items of each category of drugs on a loan license, shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs. (4) If the licensing authority is satisfied that a loan licence is defaced, damaged or lot, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan licence Form of Loan Licence; Form of loan licence to manufacture for sale or for distribution drugs specified in Schedules C and C(1) excluding the drugs specified in Schedule X and conditions for the grant or renewal of such licence; A loan licence to manufacture for sale or for distribution drugs specified in Schedules C and C (1) excluding the drugs, specified in Schedule X shall be issued in Form 28-A, and the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and date justifying that the patent or proprietary medicines; (i) certain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful; (ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations, and under the conditions in which the formulations for administration and use are recommended; (iii) are stable under the conditions of storage recommended; and

(iv) contain such ingredients and in such quantities for which there is therapeutic justifications. Conditions of Licence in Form 28-A (1) The licence in Form 28-A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 28 whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules. (2) The licensee shall comply with the provisions of the Act, and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, those would come into force four months after publication in the official Gazette. (3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. Records or registers shall be retained, in the case of a substance for which a potency date is fixed, for a period of two years from the expiry of such date and in the case of other substances, for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed. (4) The licensee shall either provide and maintain to the satisfaction of the Licensing Authority adequate staff and adequate laboratory facilities for carrying out tests of the strength, quality and purity of the substances manufactured by him or make arrangements with some institution approved by the Licensing Authority for such tests to be regularly carried out on his behalf by the institution. (5)The licensee shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which would be printed on the labels of such drugs on the basis of the data so furnished. (6)The licensee shall maintain reference samples from each batch of the drug manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the labels, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture. (7) The licensee shall maintain an Inspection Book in form 35 to enable an Inspector to record his impressions and the defects noticed. V. REPACKING LICENCES The term repacking means the process of breaking up any drug from a bulk container into small package and the labeling of each such package with a view to its sale and distribution, but does not include the compounding or dispensing or the packing of any drug in the ordinary course of the retail business.

As stated earlier a licence is required for the repacking of drugs other than those specified in Schedule C & C1. Licence for repacking of the drugs can be had on application to the Licencing Authority just like other manufacturing licence. Licence to repack for sale or distribution of drugs being drugs other than those specified in Schedules C and C (1) excluding those specified in Schedule X shall be granted in Form-25B. Application For Licence Application for licence to manufacture drugs other than those specified in Schedules C and C (1) to the Drugs and Cosmetics Rules; (1) Application for grant or renewal of licence to manufacture for sale or for distribution of drugs, other than those specified in Schedule C and C (1) shall be made to the licensing authority appointed by the State Government for the purpose of this part and shall be made in Form 24-B for repacking of drugs excluding those specified in Schedule X for sale or distribution. (2) Every application in Form24-B shall be made up to ten items for each category of drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees five hundred plus and an inspection fee of rupees two hundred for every inspection or for the purpose of renewal of the licence. (3) If a person applies for the renewal of a licence after the expiry thereof but within 6 months of such expiry the fee payable for the renewal of such licence shall be:-(i) in the case of Form 24-B a licence fee of rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in addition to an inspection fee of rupees two hundred; (4) A fee rupees one thousand shall be paid for a duplicate copy of the licence issued if the original is defaced, damaged or lost. (5) If the additional items of drugs applied for belong to categories which are not already included in the licence, be accompanied by an additional fee at the rate of rupees one hundred for each additional items of drug for repacking and rupees three hundred per additional item of drugs categorized in Schedule M and Schedule M-111. Form of Licence Form of licence to repack or manufacture drugs other than those specified in Schedules C and C (1): Licences for repacking of drugs against application in Form 24-B shall be granted in Form 25-B. Conditions for the Grant or Renewal of a Licence in Form 25-B Before a licence in Form 25-B is granted or renewed the following conditions shall be complied with by the applicant: ____ (1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person; (2) the factory premises shall comply with the conditions prescribed in Schedule M; and (3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit;

The repacking units, which before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1977, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf, may continue such arrangements upto the 31st July, 1977; Provided that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may permit such test to be conducted by institutions approved by it under Part XV (A) of these rules for this purpose. A person who satisfies the following minimum qualifications shall be deemed to be a competent person for the purposes of rules 71-A or 74-A of these rules, namely:(f) a person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is registered under the said Act, or (g) a person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the Licensing Authority as equivalent to it; or (h) a person who has passed the Matriculation examination or an examination recognized by the Licensing Authority as equivalent to it and has had not less than four years practical experience in the manufacture, dispensing or repacking of drugs. CONDITIONS OF LICENCE A licence in Fom 25-B shall be subject to the conditions stated therein and to the following conditions: ____ (a) The repacking of drugs shall at all times be conducted under the personal supervision of at least one person who is approved as a competent person by the Licensing Authority; (b) The licensee shall either provide and maintain adequate arrangements in his own premises for carrying out tests of the strength, quality and purity of the drugs repacked or make arrangements with some institution approved by the Licensing Authority under Part XV (A) of these rules for such tests to be regularly carried out on his behalf by the institution; (c) The licensee shall make adequate arrangements for the storage of drugs; (d) the licensee shall comply with the provisions of the Act and of these Rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act; Provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette. (e) The licensee shall allow any Inspector appointed under the Act to enter with or without notice, any premises where the packing of drugs in respect of which the licence is issued is carried on, to inspect the premises and to take samples of repacked drugs; (f) The licensee shall, either in his own laboratory or, in any other laboratory approved by the Licensing Authority, test each batch or lot of raw material used by him for repacking and also each batch of the product thus repacked and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a periodof five years from the date of repacking. The licensee shall allow the Inspector to inspect all registers and records maintained under

these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these Rules have been observed; (g) The licensee shall maintain an Inspection Book, in Form 35, to enable an Inspector to record his impressions and the defects noticed; (h) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference sample shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of 3 years from the date of manufacture. VI. MANUFACTURE OF WHOLE HUMAN BLOOD & COMPONENTS FOR SALE OR DISTRIBUTION Application for grant/renewal of licence for the operation of a Blood Bank for processing of whole blood and/or preparation of Blood Components shall be made in Form 27-C and application for grant/renewal of licence to manufacture blood products for sale or distribution shall be made in Form 27-E. The Respective Licence shall be issued in Form 28-C or Form 28-E. In this part; "Blood" means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant. "Blood component" means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor. "Blood products" means a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors. Form Of Application Form of application for licence for operation of Blood Bank/processing of whole human blood for components/manufacture or Blood Products for sale or distribution; Application for the grant and/or renewal of licence for the operation of Blood Bank/processing of Human Blood for components/manufacture of Blood Products shall be made to the Licensing Authority appointed under Part VII in Form 27-C or Form 27-E (Appendices 1 & 2) as the case may be and shall be accompanied by licence fees of rupees six thousand and an inspection fees of rupees one thousand and five hundred for every inspection thereof or for the purpose of renewal of licence. If the applicant applies for renewal of licence after the expiry but within 6 months of such expiry the fee payable for the renewal of the licnece shall be rupees six thousand and inspection fees of rupees one thousand and five hundred plus an additional fees at the rate of rupees one thousand per month or a part thereof in additional to the inspection fee. A licence holding a licence in Form 28 C or Form 28 E (Appendices 3 & 4) as the case may be for operation of blood bank/processing of whole human blood for components/manufacture of blood products shall apply for grant of licence for renewal under sub-rule (1) before the expiry of the said licenece on Form 27-C or Form 27-E as

the case may be and he shall continue to operate the same till the orders on his application are communicated to him. 1. Blood bank means a place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations, for collections, apheresis, storage, processing and distribution of blood drawn from donors and /or for preparation, storage and distribution of blood components. 2. A fee of rupees one thousand shall be paid for a duplicate copy of licence issued under this rule, if the original is defaced, damaged or lost. 3. Application by licensee to manufacture additional drugs listed in the application shall be accompanied by a fee of rupees three hundred for each drug listed in the application. 4. On receipt of the application for the grant or renewal of such licence, the Licensing Authority shall,(i) Verify the statements made in the application form. (i) Inspect the manufacturing and testing establishment in accordance with the provisions of rules 122-I. (i) In case the application is for renewal of licence, information of past performance of the licensee shall be verified. 5. If the Licensing Authority is satisfied that the applicant is in position to fulfill the requirements laid down in the rules, he shall prepare a report to that effect and forward it along with the application and the licence (in triplicate) to be granted or renewed, duly completed to the Central Licence Approving Authority. If the Licensing Authority is of the opinion that the applicant is not in a position to fulfill the requirements laid down in these rules, he may, by order, for reason to be recorded in writing, refuse to grant or renew the licence, as the case may be. Form Of Licence Form of licence for the operation of a Blood Bank/Processing of Whole Human Blood for components and manufacture of Blood products and the conditions for the grant or renewal of such licence; A licence for the operation of a Blood Bank or for processing Whole Human Blood for components and manufacture of blood products shall be issued in Form 28-C or Form 28-E or Form 26-G or Form 26-1. Before a licence in Form 28-C or Form 28 E or Form 26-G or Form 26-I is granted or renewed the following conditions shall be complied with by the applicant1. The operation of the Blood Bank and/or processing of whole human blood for components/ manufacture of blood product shall be carried out under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole time employee and who is a Medical Officer and possessing a) Post Graduate degree in Medicine-M.D. (Pathology/Transfusion Medicines); or b) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicine having adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; or c) Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also has adequate knowledge and experience in blood group serology,

blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components, The degree or diploma being from a university recognized by the Central Government Explanation- For the purpose of this condition, the experience in Blood Bank for one year shall not apply in the case of persons who are approved by licensing Authority and/or Central Licence Approving Authority prior to the commencement of the Drugs & Cosmetics ( Amendment) Rules,1999. 2. The applicant shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. The space, plant and equipment required for various operation is given in Schedule 'F', Part XII-B and / or XII-C. 3. The applicant shall provide and maintain adequate technical staff as specified in Schedule 'F', Part XII-B and/or XII-C. 4. The applicant shall provide adequate arrangements for storage of Whole Human Blood, Human Blood Components and blood products. 5. The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of Whole Human Blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished. Duration of Licence An original licence in Form 28-C or Form 28 -E or a renewed licence in Form 28-G or Form 28- I unless sooner suspended or cancelled shall be valid for a period of five years from the date on which the year in which it is granted or renewed. Conditions Of Licence "A licence in Form 28-C, Form 28-E shall be subject to the special conditions set out in Schedule F, Part XII-B and Part XII-C, as the case may be, which relate to the substance in respect of which the licence is granted or renewed and to the following general conditions, namely":(i)(a) The licensee shall provide and maintain adequate staff, plant and premises for the proper operation of a Blood Bank for processing whole human blood, its components and/or manufacture of blood products. (b) The licensee shall maintain staff, premises and equipments as specified in Rule 122G. The licensee shall maintain necessary records and registers as specified in Schedule F, Part XII-B and XII-C. (c) The licensee shall test in his own laboratory whole human blood, its components and blood products and maintain records and registers in respect of such tests as specified in Schedule F, Part XII-b and Part XII-C. The records and registers shall be maintained for a period of 5 years from the date of manufacture. (d) The licensee shall maintain/preserve reference sample and supply to the Inspector the reference sample of the whole human blood collected by him in adequate quantity to conduct all the prescribed tests. (i) The licensee shall allow an inspector appointed under the Act to enter, with or without prior notice, any premises where the activities of the Blood Bank are being carried out, for the processing of Whole Human Blood and/or Blood Products, to inspect the premises and plant and the process of manufacture and the means employed for standardizing and

testing the substance. (ii) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and to take samples of the manufactured product and shall supply to Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed. (iii) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the operation of a blood bank/processing of whole human blood for components and/or manufacture of blood products and any material alterations in the premises or plant used for that purpose which have been made since the date of last inspection made on behalf of the Licensing Authority before the grant of the licence. (iv) The licensee shall on request furnish to the Licensing Authority, or Central Licence Approving Authority or to such Authority as the Licensing Authority, or the Central Licence Approving Authority may direct, from any batch unit of drugs as the Licensing Authority or the Central Licence Approving may from time to time specify, sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish full protocols of the test which have been applied. (v) If the Licensing Authority or the Central Licence Approving Authority so directs, the licensee shall not sell or offer for sale any batch/unit in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sales of batch/unit has been issued to him by or on behalf of the Licensing Authority or the Central Licence Approving Authority. (vii) The licensee shall on being informed by the Licensing Authority or the Controlling" Authority that any part of any batch/unit of the substance has been found by the Licensing Authority or the Central Licence Approving Authority not to conform with the standards of strength, quality or purity specified in these Rules and on being directed to do so, withdraw, from sales and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch/unit. (viii) No drug manufactured under the licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. Further no batch/unit manufactured under this licence shall be supplied/distributed to any person without prescription of Registered Medical Practitioner. (ix) The licensee shall comply with the provisions of the Act and of these Rules and with such further requirements, if any, as may be specified in any Rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the Rules, these would come in force four months after publication in the Official Gazette. (x) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed. (xi) The licensee shall destroy the stocks of batch/unit which does not comply with standard tests in such a way that it would not spread any disease/infection by way of proper disinfection method. (xii) All bio-medical waste shall be treated, disposed off or destroyed as per the provisions of The Bio-Medical Wastes (Management and Handling) Rules 1996. The licensee shall neither collect blood from any professional donor or paid donor

nor shall he prepare blood components and/or manufacture blood products from the blood drawn from such a donor. VII. Manufacture of New Drugs The application for any new drugs including their fixed dose combinations should be accompanied by data as specified in Schedule Z. SOME OTHER PROVISIONS RELATED TO THE MANUFACTURE FOR SALE OF DRUGS A. Cancellation and Suspension of Licences; (1) The Central Licence Approving Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part, or suspend it for such period as he thinks fit either wholly or in respect of any of the drugs to which it relates 3[or direct the licensee to stop manufacture, sale or distribution of the said drugs and an Inspector, if in his opinion, the licensee has failed to comply with any of the conditions of the licencee or with any provisions of the Act or rules made thereunder. (2) The Licensing Authority may, for such licences granted or renewed by him, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reason therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, or direct the licensee to stop manufacture, sale or distribution of the said drugs and an Inspector if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provision of the Act or Rules thereunder. (3) A licensee whose lice has been suspended or cancelled by the Central Licence Approving Authority or Licensing Authority under sub-rule (1) or sub-rule (2), as the case maybe, may within ninety days of the receipt of a copy of the order by him prefer an appeal to the Central Government or the State Government, as the case may be, and the Central Government or the State Government may after giving the licensee an opportunity of being head, confirm, reverse or modify such order. B. Power of Central Government to prohibit manufacture of drug and cosmetic in public interest; Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic. C. Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates; No person shall manufacture for sale cyclamates and preparations containing cyclamates.

D. Disclosure of the name of the manufacturer; Every person, not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so required, disclose to the Inspector the name, address and other particulars of the person from whom he acquired the drug or cosmetic. E. Persons bound to disclose place where drugs or cosmetics are manufactured or kept; Every person for the time being in charge of any premises whereon any drug or cosmetic is being manufactured or is kept for sale or distribution shall, on being required by an Inspector so to do, be legally bound to disclose to the Inspector the place where the drug or cosmetic is being manufactured or is kept, as the case may be. F. Maintenance of records and furnishing of information; Every person holding a licence under this Act shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act. G. Confiscation of drugs, implements, machinery; Where any person has been convicted for contravening any of the provisions of Chapter IV (Provisions related to the Manufacture, Sale and Distribution of Drugs and Cosmetics) of the Act or any rule made thereunder, the stock of the drug in respect of which the contravention has been made shall be liable to confiscation. Where any person has been convicted for the manufacture of any drug deemed to be misbranded, or adulterated drug, or for manufacture for sale, or stocking or exhibiting for sale or distribution of any drug without a valid licence, any implements or machinery used in such manufacture, sale or distribution and any receptacle, packages, or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation. SALE OF DRUGS Sale of drug is a technical job, which requires persons with specialized training. A sale is the pinnacle activity involved in the selling products or services in return for money or other compensation. It is an act of completion of a commercial activity. "sale or sell" includes barter and exchange and also includes offering or attempting to sell or causing or allowing to be sold or exposing for sale or receiving or sending or delivering for sale or having in possession for sale or having in possession any drug knowing that the same is likely to be sold or offered or exposed for sale, and refers only to sale for human consumption or use. The seller - the provider of the goods or services - completes a sale in response to an acquisition or to an appropriation or to a request. "Dealer" means a person carrying on the business of purchase or sale of drugs, whether as a wholesaler or retailer and whether or not in conjunction with any other business, and includes his agent.

"Distributor" means a distributor of drugs or his agent or a stockiest appointed by a manufacturer or an importer for stocking his drugs for sale to a dealer. "Retailer" means a dealer carrying on the retail business of sale of drugs to customer. "Wholesaler" means a dealer or his agent or a stockiest appointed by a manufacturer or an importer for the sale of his drugs to a retailer, hospital, dispensary, medical, educational or research institution purchasing bulk quantities of drugs. Sale of drugs can be by way of:o Wholesale from the stockiest to the shopkeeper. o Retail sale from the shopkeepers to the patient. After the enforcement of D & C Act, 1940, the sale of drugs has become a restricted practice and only those persons who have been granted licence by the licencing authorities of the state, can engage in themselves in the wholesale, retail compounding or dispensing of drugs. For the purpose of issuing sale licence, the drugs have been divided in to the following categories:o Drugs specified in Schedule C and C1. o Drugs specified in Schedule X. o Drugs other than those specified in Schedule C and C1 and X. The licence are granted for retail or wholesale with respect to all the above categories. A licence for the sale of drugs remains valid upto 31st December of the year in which the licence is granted or renewed. Sale Applications, Licences, Fees and Penalty:

Fee+ Penalty Application Licence Fees for S.No. Category Type Sale after expiry but Form Form Grant/Renewal within six months Rs.1500+Rs.500 Whole Sale 19 20-B Rs.1500 p.m. or part thereof Drugs other than those Rs.1500+Rs.500 1 specified in Retail Sale 19 20 Rs.1500 p.m. or part Schedule thereof C&C (1)&X Rs.500+Rs.250 20-A Restricted(Gen.Store) 19-A Rs.500 R-59 (2) p.m. or part R-61 (1) thereof R-59 (4) Rs.1500+Rs.500 Drugs Whole Sale 19 21B Rs.1500 p.m. or part specified in thereof Schedule Rs.1500+Rs.500 C&C (1) but 2 Retail Sale 19 21 Rs.1500 p.m. or part excluding thereof those Rs.500+Rs.250 specified in 21-A Rs.500 R-59 (2) p.m. or part Schedule X Restricted(Gen.Store) 19-A R-61 (1) thereof R-59 (4) Rs.500+Rs.250 Whole Sale 19-C 20-G Rs.500 p.m. or part Drugs thereof 3 specified in Rs.500+Rs.250 Schedule X 20-F Retail Sale 19-C Rs.500 R-59(2) p.m. or part R-61(1) thereof R-59(4) Sale of Drugs from motor vehicles (1) Rs.500+Rs.250 Drugs other Whole Sale 19-AA 20-BB Rs.500 p.m. or part than those thereof specified in 4 Schedule C&C (1) (2) Drugs Rs.500+Rs.250 specified in 21-BB Whole Sale 19-AA Rs.500 p.m. or part Schedule R-62-D thereof C&C (1)

Fees for duplicate copy of Org. Lic.:-- Rs.150

Applications for the Grant A Licence Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or distribute drugs; (1) The State Government shall appoint Licensing Authorities for the purpose of sale of drugs other than homoeopathic medicines for such areas as may be specified. (2) Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or distribute drugs, other than those included in Schedule X, shall be made in Form19 accompanied by a fee of rupees one thousand and five hundred or Form 19-A. accompanied by a fee of rupees five hundred, as the case may be, or in the case of drugs included in Schedule X shall be made in Form 19-C accompanied by a fee of rupees five hundred, to the licensing authority. In the case of an itinerant vendor or an applicant who desires to establish a shop in a village or town having population of 5,000 or less, the application in Form 19-A shall be accompanied by a fee of rupees ten . (3)A fee of rupees one hundred and fifty shall be paid for a duplicate copy of a licence to sell, stock, exhibit or offer for sale or distribute drugs, other than those included in Schedule X, or for a licence to sell, stock, exhibit or offer for sale or distribute drugs, included in Schedule X, if the original is defaced, damaged or lost; In the case of itinerant vendor or an applicant who desires to established a shop in a village or town having a population of 5,000 or less, the fee for a duplicate copy of a licence if the original is defaced, damaged or lost, shall be rupees two. (4) Application for renewal of a licence to sell, stock, exhibit or offer for sale or distribute drugs, after its expiry but within six months of such expiry shall be accompanied by a fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees five hundred per month or part thereof in Form 19, rupees five hundred plus an additional fee at the rate of rupees two hundred fifty per month or part thereof in Form 19-A and rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19- C: In the case of an itinerant vendor or an applicant desiring to open a shop in a village or town having a population of 5,000 or less the application for such renewal shall beaccompanied by a fee of rupees ten, plus an additional fee at the rate of rupees eight per month or part thereof. Forms of Licences to Sell Drugs (1) a licence to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedule C, C (1) and X and by retail on restricted licence or by wholesale, shall be issued in Form 20, Form 20-A or Form 20 B, as the case may be. A licence in Form 20-A shall be valid for only such drugs as are specified in the licence. (2) A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted licence or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be. A licence in Form 21-A shall not be granted for drugs specified in Schedule C and shall be valid for only such Schedule C (1) drugs as are specified in the licence. (3)A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule X by retail or by wholesale shall be issued in Form 20-F or Form 20-G as the case may be.

 RETAIL SALE Retail sale means a sale to a purchaser for the purpose of consumption or use and not for resale. The premises that are licenced for the retail sale of drugs are: o Drugs stores (which do not have a qualified person). o Chemists and druggists (which have a qualified person). o Pharmacy, Pharmacist, Dispensing Chemist. For retail sale two types of licence are granted; o General Licence o Restricted Licence General licence is granted to persons who have premises for the business and who engage the services of a 'Qualified Persons' to supervise the sale of drugs and do the compounding and dispensing. A. GENERAL LICENCE For the purpose of issuing General Licences for retail sale the drugs are divided in to following categories:o Drugs other than those specified in Schedule C&C (1) &X in Form 20. o Drugs specified in Schedule C&C (1) but excluding those specified in Schedule X in Form 21. o Drugs specified in Schedule X in Form 20-F. Conditions for the Licence Conditions to be satisfied before a licence in Form 20, 20-F or 21 is granted; (1)A licence in Form 20, 20-F or 21 to sell, stock, exhibit or offer for sale or distribute drugs shall not be granted or renewed to any person unless the authority empowered to grant the licence is satisfied that the premise in respect of which the licence is to be granted or renewed are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs. In the case of a pharmacy a licence in Form 20 or 21 shall not be granted or renewed unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with. The licence in Form 20-F shall be granted or renewed only to a pharmacy and in areas where a pharmacy is not operating, such licence may be granted or renewed to a chemist and druggist (2)In granting a licence the authority empowered to grant it shall have regard to the average number of licences granted during the period of 3 years immediately preceding, and to the occupation, trade or business ordinarily carried on by such applicant during the period of 3 years.

The licensing authority may refuse to grant or renew a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these Rules, or the previous cancellation or suspension of any licence granted thereunder, he is not a fit person to whom a licence should be granted under this rule. Every such order shall be communicated to the licensee as soon as possible. The licencing authority shall satisfied himself that the premises in respect of which a licence is to be granted are; (i) in respect of an application for the grant of a licence in Form 20 or Form 21 or both, the licensing authority shall satisfy itself that the premises are of an area of not less than 10 square meters, and (ii) in respect of an application for the grant of a licence-(a)In Form 20 or Form 21 or both, and (b)In Form 20 B or Form 21B or both, the licensing authority shall satisfy itself that the premises are of an area not less than 15 square meter; The provisions of the preceding proviso shall not apply to the premises for which licences have been issued by the licensing authority before the commencement of the Drugs and Cosmetic (1st Amendment) Rules, 1997 (3) Any person who is aggrieved by the order passed by the licensing authority in subrule (1) may, within 30 days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, make such an order in relation thereto as it thinks fit. Licences for Retail Sale A. Drugs other than those specified in Schedule C&C (1) &X General licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in Schedules C, C(1) and X. Conditions of Licence General licence is subjected to the following conditions; 1. This licence shall be displayed in a prominent place in a part of the premises open to the public. 2. The licence shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force. 3. The licence shall report to the Licensing Authority any change in the qualified staff incharge within one month of such change. 4. No drug shall be sold unless such drug is purchased under cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. 5. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm taken place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution.

B. Drugs specified in Schedule C&C (1) but excluding those specified in Schedule X Licence to sell, stock or exhibit or offer for sale distribute by retail drugs specified in Schedules C and C(1) excluding those specified in Schedule X. Conditions of Licence 1. This licence shall be displayed in a prominent place in a part of the premises open to the public. 2. The licensee shall report to the Licensing Authority any change in the qualified staff in charge within one month of such change. 3. If the licensee wants to sell, stock or exhibit for sale or distribute, during the currency of the licence, additional categories of drugs listed in Schedules C and C (1) excluding those specified in Schedule X but not included in this licence, he should apply to the Licensing Authority for the necessary permission. This licence will be deemed to extend to the categories of drugs in respect of which such permission is given. This permission shall be endorsed on the licence by the Licensing Authority. 4. No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. 5. The licence shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place, unless in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution. C. Drugs specified in Schedule X Licence to sell stock or exhibit for sale or distribute by retail drugs specified in Schedule X Conditions of the licence 1. This licence shall be displayed in a prominent place in a part of the premises open to the public. 2. The licencee shall report to the licensing authority any change in the qualified staff incharge within one month of such change. 3. No drug shall be stocked or sold unless such drug has been purchased under cash/credit memo from a duly licensed dealer or a duly licensed manufacturer. 4. The licensee shall inform the licensing authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution. B. RESTRICTED LICENCES A restricted licence is granted to persons who deal in sale of drugs, do not require the service of a qualified person.

For the purpose of issuing Restricted Licences for retail sale the drugs are divided in to following categories(i) Drugs other than those specified in Schedules C, C (1) and X; and (ii) Drugs specified in Schedule C, C1 and excluding X. Form of licence; o Restricted Licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in Schedules C, C (1) and X for dealers who do not engage the services of a qualified person in Form 20A. o Licence to sell, stock or exhibit or offer for sale distribute by retail drugs specified in Schedule C, C1 and excluding X for dealers who do not engage the services of a qualified person in Form 21A. o No licence is granted in this category for drugs specified in Schedule X. Restricted Licences In Forms 20-A And 21-A (a) Restricted licences in Forms 20-A and 21-A shall be issued subject to the discretion of the Licensing Authority, to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person. (b)Licences to itinerant vendors shall be issued only in exceptional circumstances for bona fide traveling agents of firms dealing in drugs or for a vendor who purchases drugs from a licensed dealer for distribution in sparsely populated rural areas where other channels of distribution of drugs are not available. (c)The licensing authority may issue a licence in Form 21-A to a travelling agent of a firm but to no other class of itinerant vendors for the specific purpose of distribution to medical practitioners or dealers, samples of biological and other special products specified in Schedule C. Provided that traveling agents of licensed manufacturers, agents, of such manufacturers and importers of drugs shall be exempted from taking out licence for the free distribution of samples of medicines among members of the medical profession, hospitals, dispensaries and the medical institution or research institutions. Conditions For The Grant Of Restricted Licences Conditions to be satisfied before a licence in Form 20-A or Form 21-A is granted:(1) A licence in Form 20-A or Form 21-A shall not be granted to any person, unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are adequate and equipped with proper storage accommodation for preserving the properties of drugs to which the licence applies. Provided that this condition shall not apply in the case of licence granted itinerant vendors. (2)In granting a licence the authority empowered to grant it shall have regard to:(i) the number of licences granted in the locality during one year immediately preceding; and (ii) the occupation, trade or business carried on by such applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these Rules or the previous cancellation or suspension of any licence

granted thereunder, he is not a fit person to whom a licence should be granted under this Rule. (3) Any person who is aggrieved by the order passed by the licensing authority in subrule (1) may, within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter make such order in relation thereto as it thinks fit. Conditions of Licence in Form-20A and Form-21A-1. This licence shall be displayed in a prominent and conspicuous place in a part of the premises open to public or shall be kept on the process of the vendor who shall produce it on demand by an Inspector or an officer authorised by the State Government in this behalf. 2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force. 3. The licensee shall deal only in such drugs as can be sold without the supervision of a qualified person as defined under the Drugs and Cosmetics Rules, 1945. 4. No drug shall be sold unless such drug is purchased under cash or credit memo from duly licensed manufacturer. 5. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution. WHOLESALE OF DRUGS Wholesale means the selling of goods in relatively large quantities and usually at lower prices than at retail, esp. such selling to retailers for resale to consumers. Wholesale of drugs means sale of drugs to the hospitals, dispensaries, medical, educational and research institutions and to the person who purchases it for selling again. For the purpose of issuing sale licence by wholesale the drugs are divided in to following categories; o Drugs other than those specified in Schedule C&C (1) &X in Form-20B. o Drugs specified in Schedule C&C (1) but excluding those specified in Schedule X in Form 21-B. o Drugs specified in Schedule X in Form 21-C. Sale of Drugs from motor vehicles; o Drugs other than those specified in Schedule C&C (1) in Form-20-BB. o Drugs specified in Schedule C&C (1) in Form-21-BB. Conditions for a Licence to Sale Drugs by Wholesale Conditions to be satisfied before a licence in Form 20-B, 20-G, or 21-B is granted; (1)A licence in Form 20-B, 20-G, or 21-B to sell, stock, exhibit or offer for sale or distribute drugs shall not be granted or renewed to any person unless the authority

(i) (ii)

empowered to grant the licence is satisfied that the premise in respect of which the licence is to be granted or renewed are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs : (2)In granting a licence the authority empowered to grant it shall have regard to the average number of licences granted during the period of 3 years immediately preceding, and to the occupation, trade or business ordinarily carried on by such applicant during the period aforesaid The licensing authority may refuse to grant or renew a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these Rules, or the previous cancellation or suspension of any licence granted thereunder, he is not a fit person to whom a licence should be granted under this rule. Every such order shall be communicated to the licensee as soon as possible. In respect of an application for the grant of a licence in form 20-B or form 21-B or both, the licensing authority shall satisfy himself that the premises in respect of which a wholesale licence is to be granted are:-of an area of not less than ten square meters; and in the charge of a competent person, who (c) is a Registered Pharmacist, or, (d) has passed the matriculation examination or its equivalent examination from a recognised Board with the four years experience in dealing with sale of drugs, or; (e) holds a degree of a recognised University with one years experience in dealing with drugs. (3) Any person who is aggrieved by the order passed by the licensing authority may, within 30 days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, make such an order in relation thereto as it thinks fit. LICENCES FOR SALE OF DRUGS BY WHOLESALE 1. Drugs Other Than Specified In Schedules C, C (I) and X-Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale, drugs other than specified in Schedules C, C(I) and X. Conditions of Licence The licence is issued in Form 20B is subjected to the following conditions; 1. This licence shall be displayed in a prominent place in part of the premises open to the public. 2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules thereunder for the time being in force. 3.(i) No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer.

(ii) No sale of any drug shall be made to a person not holding the requisite licence to sell, stock or exhibit for sale or distribute the drug. Provided that this condition shall not apply to the sale of any drug to-(a) an officer or authority purchasing on behalf of Government, or (b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or (c) a manufacturer of beverages, confectional biscuits and other nonmedicinal products, where such drugs are required for processing these products. 4. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm taken place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the changes takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution. 2. Drugs specified in Schedule C&C (1) but excluding those specified in Schedule X-Licence to sell, stock or exhibitor offer for sale or distribute by wholesale drugs specified in Schedules C and C (1) excluding those specified in Schedule X. Conditions of Licence in Form 21-B The licence is issued in Form 21B is subjected to the following conditions; 1. This licence shall be displayed in a prominent place in a part of the premises open to the public. 3. If the licensee wants to sell, stock or exhibit for sale or distribute during the currency of the licence additional categories of drugs listed in Schedule C and C (1) excluding those specified in Schedule X but not included in this licence. He should apply to the Licensing Authority for the necessary permission. This licence will be deemed to extend to the categories of drugs in respect of which such permission is given. This permission shall be endorsed on the licence by the Licensing Authority. 4. (i) No drug shall be sold unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. (ii) No sale of any drug shall be made for purposes of resale to a person not holding the requisite licence to sell, stock or exhibit for sale or distribute the drug. Provided that this condition shall not apply to the sale of any drug to (a) an officer or authority purchasing on behalf of Government, or (b) a hospital, medical, educational or research institute or a registered medical practitioner for the purpose of supply to his patients, or (c) a manufacturer of hydrogenated vegetable oils, beverages, confectionary and other non-medicinal products, where such drugs are required for processing these products 3. Drugs specified in Schedule X-Licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X. Conditions of the licence

The licence is issued in Form 20G is subjected to the following conditions; 1. This licence shall be displayed in a prominent place in a part of the premises open to the public. 2. The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder. 3. No drug shall be stocked or sold unless such drug has been purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. 4. The licensee shall forward to the licensing authority copies of the invoices of sales made to the retail dealers. 5. No sale of any drug by wholesale shall be made to a person not possessing the requisite licence to sell, stock or exhibit for sale or distribute drugs specified in Schedule X : Provided that this condition shall not apply to the sale of any drug to (d) an officer or authority purchasing on behalf of Government; (e) a hospital, medical, educational or research institution, nursing home, Registered Medical Practitioner for the purpose of supply to its/his patients or manufacturer holding a licence in Form 25-E or 28-B to manufacture the drugs containing drug included in Schedule X. The licensee shall inform the licensing authority in writing in the event of any change in the constitution of the firm operating under the licence, where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution. SALE OF DRUGS FROM MOTOR VEHICLES; Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle: Application for the grant or renewal of a licence to sell by wholesale or to distribute from a motor vehicle shall be made to the Licensing Authority in Form 19-AA and shall be accompanied by a fee of rupees five hundred. If the applicant applies for the renewal of a licence after its expiry but within 6 months of such expiry, the fee payable for renewal of such licence shall be rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof. A fee of rupees one hundred fifty shall be paid for a duplicate copy of a licence issued under this rule, if the original is defaced, damaged or lost. Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicles. A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule and Schedule C (1) in Form 20BB and of drugs specified in Schedule C and Schedule C(1) in Form 21BB. Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drug. (1) Drugs other than those specified in Schedule C&C (1):--

Licence to sell, stock or exhibit or offer for sale by wholesale, or distribute drugs other thanm those specified in Schedule C and Schedule C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle. Conditions of Licence The licence is issued in Form 20BB is subjected to the following conditions; 1. This licence shall be displayed in prominent place on the vehicle. 2. The licence shall comply with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder for the time being in force. 3(i)No drugs shall be sold by wholesale or distributed unless such drug is purchased under a cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. (ii) No sale by wholesale or distribution of any drug shall be made to a person not holding the requisite licence to sell, stock, or exhibit for sale or distribute the drug: Provided that this condition shall not apply to the sale of any drug to-a) an officer or authority purchasing on behalf of the Government, or b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or c) a manufacturer of beverages, confectionary, biscuits and other nonmedical products where such drugs are required for processing these products. 4. The licensee shall inform the Licensing Authority in writing in the event of change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution. 5. The licensee shall inform the Licensing Authority in writing in the event of any change in ownership of the vehicle specified in this licence within seven days of such change. (2) Drugs specified in Schedule C&C (1):-Licence to sell by wholesale or to distribute drugs specified in Schedule C and Schedules C (1) to the Drugs and Cosmetics Rules, 1945 from a motor vehicle. Conditions of licence The licence is issued in Form 21BB is subjected to the following conditions; 1. This licence shall be displayed in a prominent place on the vehicle. 2. No drugs to which this licence applies shall be sold by the Licensing Authority from time to time in the Official Gazette has been observed throughout the period during which it has been in the possession of the licensee. 3. If the licensee wants to sell by wholesale or distribute during the currency of the licence, additional categories of drugs listed in Schedule C and C (1) not included in this licence, he shall apply to the Licensing Authority for necessary permission. This licence shall be deemed to extend to the categories of drugs in respect of which such permission is given. This shall be endorsed on the licence by the Licensing Authority. 4. (i) No drugs shall be sold by wholesale or distributed unless such drug is purchased under a cash or credit memo from a duly licensed manufacturer.

(ii) No sale for wholesale or distribution of any drug shall be made for the purpose of resale to a person, not holding the requisite licence to sell stock or exhibit for sale or distribute the drug: Provided that this condition shall not apply to the sale of any drug to. (a) an officer or authority purchasing on behalf of the Government. (b) a hospital, medical, educational or research institution or a registered medical practitioner for the purpose of supply to his patients, or (c) a manufactures of hydrogenated vegetable oils, beverages, confectionary and other non-medical products, where such drugs are required for processing their products. 5. The licensee shall inform the Licensing Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the Licensing Authority in the name of the firm with the changed constitution. 6. The licensee shall inform the Licensing Authority in writing in the event of any change in the ownership of the vehicle specified in this licence within seven days of such change. DISPENSING AND COMPOUNDING OF DRUGS: Any drug shall, if compounded or made on the licensees premises be compounded or made under the direct and personal supervision of a registered Pharmacist. 1. For the purpose of this rule the term Pharmacy shall be held to mean to include every store or shop or other place: (1) Where drugs are dispensed, that is, measured or weighed or mode up and supplied; or (2) Where prescriptions are compounded; or (3) Where drugs are prepared; or (4) Which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical Chemist; or (5) Which, by sign, symbol or indication within or. upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or (6) Which is advertised in terms referred to in (4) above. 2. The premises licenced for the retail sale of drugs may be described as; (a) The description Drugstore shall be displayed by such licensees who do not require the services of a qualified person. (b) The description Chemists and Druggists shall be displayed by such licensees who employ the services of a registered Pharmacist but who do not maintain a Pharmacy for compounding against prescriptions: (c) The description Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical Chemist shall be displayed by such licensees who employ the services of a Registered Pharmacist and maintain a Pharmacy for compounding against prescriptions: For the purpose of this rule, ---

(i) Registered Pharmacist means a person who is a registered Pharmacist as defined under the Pharmacy Act, 1948. The provisions of sub-clause (i) shall not apply to those persons who are already approved as qualified person by the Licensing authority on or before 31st December 1969. (ii) Date of Expiry of potency means the date that is recorded on the container, label or wrapper as the date up to which the substance may be expected to retain potency not less than or not to acquire toxicity greater than that required or permitted by the prescribed test. 3. In granting a licence for a pharmacy the authority empowered to grant it shall have regard--(i)to the average number of licences granted during the period of 3 years immediately preceding, and (ii)to the occupation, trade or business ordinarily carried on by such applicant during the preceding 3 years. 4. The supply of any drug other than those specified in Schedule X on a prescription of a Registered Medical Practitioner (RMP) shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription. The following particulars shall be entered in the register: _ (a) serial number of the entry, (b) the date of supply, (c) the name and address of the prescriber, (d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use (e) the name of the drug or preparation and the quantity or in the case of a medicine made up by the licensee, the ingredients and quantities thereof, (f) in the case of a drug specified in Schedule C or Schedule H the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any, (g) the signature of the registered Pharmacist by or under whose supervision the medicine was made up or supplied. In the case of drugs which are not compounded in the premises and which are supplied from or in the original containers, the particulars specified in items (a) to (g) above may be entered in a cash or credit memo book, serially numbered and specially maintained for this purpose. If the medicine is supplied on a prescription on which the medicine has been supplied on a previous occasion and entries made in the prescription register, it shall be sufficient if the new entry in the register includes a serial number, the date of supply, the quantity supplied and a sufficient reference to an entry in the register recording the dispensing of the medicine on the previous occasion. 5. It shall not be necessary to record the above details in the register or in the cash or credit memo particulars in respect of: ___ (i) any drugs supplied against prescription under the Employees State Insurance Scheme if all the above particulars are given in that prescription, and (ii) any drug other than that specified in Schedule C or Schedule H if it is supplied in the original unopened container.

 SUPPLY OF DRUGS AND RECORD OF DRUGS (1) Any drug shall, if compounded or made on the licensees premises be compounded or made under the direct and personal supervision of a registered Pharmacist. (2) The supply, otherwise than by way of wholesale dealing, of any drug supplied on the prescription of a Registered Medical Practitioner shall be affected only by or under the personal supervision of a registered Pharmacist. The supply of any drug other than those specified in Schedule X on a prescription: (3) (I)The supply of any drug other than those specified in Schedule X on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription. The following particulars shall be entered in the register: _ (a) serial number of the entry, (b) the date of supply, (c) the name and address of the prescriber, (d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use. (e) the name of the drug or preparation and the quantity or in the case of a medicine made up by the licensee, the ingredients and quantities thereof, (f) in the case of a drug specified in Schedule C or Schedule H the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any, (g) the signature of the registered Pharmacist by or under whose supervision the medicine was made up or supplied. In the case of drugs which are not compounded in the premises and which are supplied from or in the original containers, the particulars specified in items (a) to (g) above may be entered in a cash or credit memo book, serially numbered and specially maintained for this purpose: If the medicine is supplied on a prescription on which the medicine has been supplied on a previous occasion and entries made in the prescription register, it shall be sufficient if the new entry in the register includes a serial number, the date of supply, the quantity supplied and a sufficient reference to an entry in the register recording the dispensing of the medicine on the previous occasion. It shall not be necessary to record the above details in the register or in the cash or credit memo particulars in respect of: ___ (i) any drugs supplied against prescription under the Employees State Insurance Scheme if all the above particulars are given in that prescription, and (ii) any drug other than that specified in Schedule C or Schedule H if it is supplied in the original unopened container of the manufacturer and if the prescription is duly stamped at the time of supply with the name of the supplier and the date on which the supply was made and on condition that the provisions this rule are complied with.

(II)The option to maintain a prescription register or a cash or credit memo book in respect of drugs and medicines which are supplied from or in the original container, shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of the licence to sell by retail. The Licensing Authority may require records to be maintained only in prescription register if it is satisfied that the entries in the carbon copy of the cash or credit memo book are not legible. Supply of drug specified in Schedule C on prescription: (4) (I) The supply by retail, otherwise than on a prescription of a drug specified in Schedule C shall be recorded at the time of supply either: (i) in a register specially maintained for the purpose in which the following particulars shall be entered : (a) serial number of the entry, (b) the date of supply, (c) the name and address of the purchaser, (d) the name of the drug and the quantity thereof, (e) in the case of a drug specified in Schedule C, the name of the manufacturer, the batch number and the date of expiry of potency, (f) the signature of the person under whose supervision the sale was effected, or (ii) in a cash or credit memo book, serially numbered containing all the particulars. NOTE: The entries in the carbon copy of the cash or credit memo which is retained by the licensee shall be maintained in a legible manner. (II) The option to maintain a register or a cash or credit memo book shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of a licence to sell by retail. The Licensing Authority may require records to be maintained in a register if it is satisfied that the entries in the carbon copy of the cash/credit memo book are not legible. (III)(i) The supply by retail of any drug shall be made against a cash/credit memo which shall contain the following particulars: ____ Name, address and sale licence number of the dealer, Serial number of the cash/credit memo, the name and quantity of the drug supplied. (ii)Carbon copies of cash/credit memos shall be maintained by the licensee as record. (IV) Records of Purchase of a Drug Sold by Retail: (i) Records of purchase of a drug intended for sale or sold by retail shall be maintained by the licensee and such records shall show the following particulars, namely:-(a) the date of purchase, (b) the name and address of the person from whom purchased and the number of the relevant licence held by him, (c) the name of the drug, the quantity and the batch number, and (d) the name of the manufacturer of the drug. (ii) Purchase bills including cash or credit memo shall be serially numbered by the licensee and maintained by him in a chronological order,

(a) (b) (c)

(a) (b)

(c) (d) (e)

(5) The Supply of Drugs by Wholesale: (I) Subject to the other provisions of these rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act in which the following particulars shall be entered____ the date of sale. the name, address of the licensee to whom sold and his sale licence number. In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered Medical Practitioner (RMP) for the purpose of supply to his patients the name and address of the authority, institution or the Registered Medical Practitioner as the case may be, the name of the drug, the quantity and the batch number, the name of the manufacturer. the signature of the competent person under whose supervision the sale was effected. (II)Carbon copies of cash or credit memos specified in clause (1) shall be preserved as records for a period of three years from the date of the sale of the drug. (III) Records Of Purchase Of Drugs Sold By Wholesale: (i) Records of purchase of a drug intended for resale or sold by wholesale shall be maintained by the licensee and such records shall show the following particulars, namely:-(a) the date of purchase, (b) the name, address and the number of the relevant licence held by the person from whom purchased, (c) the name of the drug, the quantity and the batch number, and (d) the name of the manufacturer of the drug. (ii) Purchase bills including cash or credit memos shall be serially numbered by the licensee and maintained by him in a chronological order. (6) The licensee shall produce for inspection by an Inspector appointed under the Act on demand all registers and records maintained under these Rules, and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed. (7) Except where otherwise provided in these Rules, all registers and records maintained under these Rules shall be preserved for a period of not less than 2 years from the date of the last entry therein. (8)Notwithstanding anything contained in this Rule it shall not be necessary to record particulars in a register specially maintained for the purpose if the particulars are recorded in any other register specially maintained under any other law for the time being in force. Substances specified in schedule H or schedule X:

(9) (a) Substances specified in Schedule H or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of 2 years. (b)The supply of drugs specified in Schedule H or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of 2 years; (10) For the purposes of Schedule H or Schedule X a prescription shall____ (a) be in writing and be signed by the person giving it with his usual signature and be dated by him; (b) specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use; (c) indicate the total amount of the medicine to be supplied and the dose to be taken. (11) The person dispensing a prescription containing a drug specified in Schedule H and Schedule X shall comply with the following requirements in addition to other requirements of these Rules____ (a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once; (b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions; (c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed. (11-A) No person dispensing a prescription containing substances specified in Schedule H or X, may supply any other preparation, whether containing the same substance or not, in lieu thereof. (12) Substances specified in Schedule X kept in retail shop or premises used in connection therewith shall be stored (a) under lock and key in cupboard or drawer reserved solely for the storage of these substances ;or (b) in a part of the premises separated from the remainder of the premises and to which only responsible persons have access. (13) The Premises Related To The Retail Sale Of Drugs: The description Drugstore shall be displayed by such licensees who do not require the services of a qualified person. The description Chemists and Druggists shall be displayed by such licensees who employ the services of a registered Pharmacist but who do not maintain a Pharmacy for compounding against prescriptions. The

description Pharmacy, Pharmacist, Dispensing Chemist or Pharmaceutical Chemist shall be displayed by such licensees who employ the services of a registered Pharmacist and maintain a Pharmacy for compounding against prescriptions: (14) The license shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed. (15)Provision Related To Sale Of Drug After Expiration: No drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper. Provided that any such drugs in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks and all such drugs shall be kept in packages or cartons, the top of which shall display prominently, the words Not for sale. (16) Provision Related To The Distribution Of Drugs To The Medical Profession As Free Sample: No drug intended for distribution to the medical profession as free sample which bears a label on the container as specified in rule 96, and no drug meant for consumption by the Employees State Insurance Corporation, the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government institutions, which bears a distinguishing mark or any inscription on the drug or on the label affixed to the container thereof indicating this purpose shall be sold or stocked by the licensee on his premises. Provided that this sub- rule shall not be applicable to licensees who have been appointed as approved chemists, by the State Government in writing, under the employees State Insurance Scheme, or have been appointed as authorized agent or distributor, by the manufacturer in writing, for drugs meant for consumption under the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government Institutions for drugs meant for consumption under those schemes or have been appointed as authorized Depots or Carrying and Forwarding agent by the manufacturer in writing, for storing free samples meant for distribution to medical profession. subject to the conditions that the stock shall be stored separately from the trade stocks and shall maintain separate records of the stocks received and distributed by them. (17) The Supply By Retail Of Drugs Under The Direct Supervision Of The Registered Pharmacist: The supply by retail of any drug in a container other than the one in which the manufacturer has marketed the drug, shall be made only by dealers who employ the services of a registered Pharmacist and such supply shall be made under the direct

(a) (b) (c)

supervision of the registered Pharmacist in an envelope or other suitable wrapper or container showing the following particulars on the label: name of the drug, the quantity supplied, the name and address of the dealer. (18) Provision related to the Supply of drugs for treatment of animals: The medicines for treatment of animals kept in a retail shop or premises shall be labeled with the words Not for human use__ for treatment of animals only and shall be stored____ (a) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or (b) in a part of the premises separated from the remainder of the premises to which customers are not permitted to have access. (19) The Supply of Drugs Specified In Schedule X: (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply in a register (bound and serially page numbered) specially maintained for the purpose and separate pages shall be allotted for each drug. (b) The following particulars shall be entered in the said register, namely:-(i) Date of transaction; (ii) Quantity received, if any, the name and address of the supplier and the number of the relevant licence held by the supplier; (iii) Name of the drug; (iv) Quantity supplied; (v) Manufacturers name; (vi) Batch No. or Lot No; (vii) Name and address of the patient purchaser; (viii) Reference Number of the prescription against which supplies were made. (ix) Bill No and date in respect of purchases and supplies made by him; (x) Signature of the person under whose supervision the drugs have been supplied. OTHER PROVISIONS RELATED TO THE SALE OF DRUGS A. Power of Licensing Authority A licensing authority may with the approval of the State Government by an order in writing delegate the power to sign licences and such other powers as may be specified in the order to any other person under his control. B. Sale at more than one place If drugs are sold or stocked for sale at more than one place, separate application shall be made, and a separate licence shall be issued, in respect of each such place. Provided that this shall not apply to itinerant vendors who have no specified place of business and who will be licensed to conduct business in a particular area within the jurisdiction of the licensing authority.

C. Duration of licence An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled, shall be valid for a period of 5 years on and from the date on which it is granted or renewed. If the application for renewal of licence in force is made before its expiry or if the application is made within 6 months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry. D. Cancellation and suspension of licences (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder. Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority:___ (a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company by a partner of the firm or a director of the company, or (b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or (c) if the act or omission was a continuing act or omission, he had not or could not reasonable have had knowledge of that previous act or omission, or (d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed. (2)A licensee whose licence has been suspended or cancelled may, within 3 months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same. E. Procedure for disposal of drugs in the event of cancellation of licence (1) In case a licensee, whose licence has been cancelled, desires to dispose of drugs he has in his possession in the premises in respect of which the licence has been cancelled, he shall apply in writing to the licensing authority for this purpose, giving the following particulars, namely: (a) the name and address of the person to whom the drugs are proposed to be sold or supplied together with the number of the licence for sale or manufacture as the case may be held by him.

(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry, if any, proposed to be sold to the person mentioned in clause (a). (2) The licensing authority may, after examination of the particulars referred to in subrule (1) and, if necessary, after inspection by an Inspector of the premises where the drugs are stocked, grant the necessary permission for their disposal. OFFENCES AND PENALTIES FOR MANUFACTURES, SALES OF DRUGS AND COSMETICS I. Penalty for manufacture, sale of drugs Under Section 27 Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes, (a) any drug deemed to be adulterated or spurious or which when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code, solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be punishable with imprisonment for a term which shall not be less than 5 years but which may extend to a term of life and with fine which shall not be less than ten thousand rupees(10,000 Rs.); (b) any drug i. deemed to be adulterated, but not containing any toxic or harmful substance which may render it injurious to health , or ii. without a valid licence shall be punishable with imprisonment for a term which shall not be less than 1 year but which may extend to 3 years and with fine which shall not be less than five thousand rupees(5,000). Provided that the Court may, for any adequate and special reasons to be recorded in the judgment, impose a sentence of imprisonment for a term of less than 1 year and of fine of less than five thousand rupees (5,000); Penalty for subsequent offence; whoever having been convicted of an offence under clause (b) of this section is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than 2 years but which may extend to 6 years with fine which shall not be less than ten thousand rupees(10,000 Rs.). Provided that the Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than 2 years and of fine of less than ten thousand rupees(10,000 Rs.); (c) any drug deemed to be spurious, but not being a drug referred to in clause (a) shall be punishable with imprisonment for a term which shall not be less than 5 years and with fine which shall not be less than five thousand rupees(5,000 rupees). Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment, impose a sentence of imprisonment for a term of less than three years but not less than one year; Penalty for subsequent offence;

whoever having been convicted of an offence under clause (c) of this section, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than six years but which may extend to 10 years and with fine which shall not be less than ten thousand rupees(10,000 Rs.). (d) any drug, other than a drug referred to in clause (a) or clause (b) or clause (c), in contravention of any other provision of this Chapter or any rule made thereunder, shall be punishable with imprisonment for a term which shall not be less than 1 year but which may extend to 2 years and with fine. Provided that the Court may, for any adequate and special reasons, to be recorded in the judgment imposes a sentence of imprisonment for a term of less than 1 year. Penalty for subsequent offence; Whoever having been convicted of an offence under clause (d) of this section, is again convicted of an offence under that clause shall be punishable with imprisonment for a term which shall not be less than 2 years but which may extend to 4 years or with fine which shall not be less than five thousand rupees (5,000 Rupees), or with both; II. Penalty for manufacture, sale of cosmetics Whoever himself or by any other person on his behalf manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale (i) any cosmetic deemed to be spurious shall be punishable with imprisonment for a term which may extend to 3 years and with fine; (ii) any cosmetic other than a cosmetic referred to in clause (i) above in contravention of any provision of this Chapter or any rule made thereunder shall be punishable with imprisonment for a term which may extend to 1 year or with fine which may extend to one thousand rupees(1,000 Rupees) or with both. Penalty for subsequent offence; Whoever, having been convicted of an offence under above section is again convicted under that section, shall be punishable with imprisonment for a term which may extend to 2 years, or with fine which may extend to two thousand rupees (2,000 Rupees), or with both. III. Penalty for non-disclosure of the name of the manufacturer Whoever not disclosing the name of the manufacturer, or the place where the manufactured drug are kept shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to one thousand rupees (1,000 Rs.);, or with both. IV. Penalty for not keeping documents and for non-disclosure of information; Whoever not keeping records of manufacture or sale of drugs in the special manner shall be punishable with imprisonment for a term which may extend to 1 year or with fine which may extend to one thousand rupees (1,000 Rs.);or both.

V. Penalty for manufacture of drugs or cosmetics in contravention of section 26A; (Under Section 28B) Whoever himself or by any other person on his behalf manufactures or sells or distributes any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification shall be punishable with imprisonment for a term which may extend to 3 years and shall also be liable to fine which may extend to five thousand rupees (5,000 Rs.). VI. Penalty for use of Government Analysts report for advertising; Whoever uses any report of a test or analysis made by the Central Drugs Laboratory or by a Government Analyst, or any extract from such report, for the purpose of advertising any drug or cosmetic, shall be punishable with fine, which may extend to five hundred rupees(5,00 Rs.); Penalty for subsequent offence; Whoever, having been convicted of an offence under above section is again convicted of an offence under the same section shall be punishable with imprisonment which may extend to 10 years or with fine, or with both. MISCELLANEOUS PROVISIONS A. Confiscation (1) Where any person has been convicted under the provision related to manufacture and sale of drugs for contravening any such provision related to manufacture and sale of drugs or any rule made thereunder as may be specified by rule made in this behalf, the stock of the drug or cosmetic in respect of which the contravention has been made shall be liable to confiscation and if such contravention is in respect of (i) manufacture of any drug deemed to be misbranded, adulterated or spurious under the provision related to manufacture and sale of drugs; or (ii) manufacture for sale, or for distribution, sale, or stocking or exhibiting or offering for sale, or distribution of any drug without a valid licence as required; any implements or machinery used in such manufacture, sale or distribution and any receptacles, packages or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation. (2) Without prejudice to the provisions contained in sub-section (1) where the Court is satisfied, on the application of an Inspector or otherwise and after such inquiry as may be necessary that the drug or cosmetic is not of standard quality or is misbranded, adulterated or spurious drug or misbranded or spurious cosmetic, such drug or, as the case may be, such cosmetic shall be liable to confiscation. B. Cognizance of Offence (1) No prosecution under the provision related to manufacture and sale of drugs shall be instituted except by an Inspector or by the person aggrieved or by a recognised consumer association whether such person is a member of that association or not.

(2) No court inferior to that of a Metropolitan Magistrate or of a Judicial Magistrate of the first class shall try an offence punishable under the provision related to manufacture and sale of drugs. (3) Nothing contained in this Chapter shall be deemed to prevent any person from being prosecuted under any other law for any act or omission which constitutes an offence against this Chapter. C. Exemption The drugs specified in schedule K shall be exempted from the provisions of Chapter IV (Provisions Related to the Manufacture, Sale and Distribution of Drugs and Cosmetics) of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule. LABELLING AND PACKING OF DRUGS Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells. In many countries it is fully integrated into government, business, institutional, industrial, and personal use. Package labelling or labeling is any written, electronic, or graphic communications on the packaging or on a separate but associated label. PACKING OF DRUGS (1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P-1 to these rules. (2) The pack sizes of drugs not covered by the Schedule P-1 shall be as given below: Unless specified otherwise in Schedule P-1, (i) The pack sizes for Tablets/Capsules shall be- Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack size of Tablets/Capsules shall contain multiples of 5. (ii) The pack sizes for liquid Oral preparations shall be 30ml (paediatric only) 60 ml/100 ml/200 ml/450 ml. (iii)The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml. (iv)The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml. (v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm. Provided that the provisions of the pack sizes covered under this rule shall not apply to: 1. Pack sizes or dosage forms not covered by the foregoing provisions of this rule. 2. The imported formulations in finished form. 3. Preparations intended for Veterinary use. 4. Preparations intended for Export.

5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral forms, Unit dose (including applicaps). 6. Pack sizes of dosage form meant for retail sale to Hospitals, Registered Medic al practitioners, Nursing Homes. 7. Physicians Samples. 8. Pack sizes of large volume intravenous fluids. Provided also that pack sizes of any of the new drug as and when approved by the Licensing Authority appointed under Rule 21 and if not covered under this rule, shall be examined for the purpose of approval with the specific justification by the said Licensing Authority. Provided further that Oxytocin injection meant for sale shall be in single unit blister pack only. Packings of Drugs Specified In Schedule X The drugs specified in Schedule X shall be marketed in packings not exceeding(i) 100 unit doses in the case of tablets/capsules. (ii) 300ml in the case of oral liquid preparations. (iii) And 5 ml in the case of injections. Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that(i) such supplied are made by the manufacturers or distributors direct to the hospital/dispensaries; and (ii) hospital packs shall not be supplied to a retain dealer or to a Registered Medical Practitioner. LABELING OF DRUGS The term labelling designates all labels and other written, printed or graphic matter up on or in any package or wrapper in which it is enclosed. The label states the name of the preparation, percentage content of drug of a liquid preparation, the amount of active ingredient of a dry preparation, the volume of liquid to be added to prepare an injection or suspension from a dry preparation, the route of administration, a statement of storage condition and expiry date. Also label must indicate the name of manufacturer or distributors and carry an identifying lot number. General labeling requirments Manner of Labelling; (1) Subject to the provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering which the container is packed, namely : --(i) The name of the drug; For this purpose, the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name and shall be (a) For drugs included in the Schedule F or Schedule F (1), the name given therein;

(b) For drugs included in the India Pharmacopoeia or the official pharmacopoeia and official compendia of drug standards prescribed in the rule 124, the name or synonym specified in the respective official pharmacopoeias and official compendia of drug standards followed by the letters I.P., or, as the case may be, by the recognized abbreviations of the respective official pharmacopoeias and official compendia of drug standards; (c) For drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters N.F.I.; (d) for other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international non-proprietary name is not published, the name descriptive of the true nature or origin of the substance; (ii) A correct statement of the net content in terms of weight, measure, volume, number of units of contents, number of units of activity, as the case may be, and the weight, measure and volume shall be expressed in Metric system. (iii) The content of active ingredients. This shall be expressed--(a) for oral liquid preparations in terms of the content per single dose being indicated in 5 milliliters Provided that where the dose is below 5 milliliters the contents of active ingredients may be expressed in terms of one milliliter; or fraction thereof. Provided further that where the single dose is more than 5 milliliters, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority. (b) for liquid parenteral preparations ready for administration in terms of 1 milliliters or percentage by volume or per dose in the case of single dose container. Provided that if the preparation is contained in an ampoule it will be enough of the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale; (c) For drugs in solid form intended for parenteral administration, in terms of units or weight per milligram or gram; (d) For tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be; (e) for other preparations, in terms of percentage by weight or volume or in terms of unit age per gram or milliliter, as the case may be. Provided that clause (iii) shall not apply to the pharmacopoeial preparations where the composition of such preparation where the composition of such preparation is specified in the respective pharmacopoeia and to a preparation included in the National Formulary of India; (iv) The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured. Provided that of the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the manufacturer and his principal place of manufacture are shown; (v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words Batch No. or B. No. or Batch or Lot No. or Lot;

NOTE:(2) In the case of drugs manufactured by a continuous process, like manufacture of magnesium sulphate, pharmaceutical chemicals etc., the production resulting in one homogenous mix of the finished products shall be considered as one Batch. (3) In the case of powders, liquid orals, ointments etc., one Batch Number shall be assigned to all the containers filled from one homogenous bulk. (4) In the case of tablets, capsules, lozenges, troches, etc., one Batch Number shall be assigned to the products manufactured from one homogenous mix ready for compression or filling. (5) In the case of parenteral preparations sterilized by steam under pressure, one Batch Number shall be assigned to all containers filled from one homogenous bulk solution and sterilized in one sterilizer load. (6) In the case of containers of parenteral preparations filled from one homogenous bulk solution and sterilized in more than one sterilizer load, the Batch Number assigned to the containers in the different sterilizer loads shall be the same Batch Number as is assigned to the homogenous bulk solution, provided the samples taken from all the sterilizer loads pass the sterility test, and are kept separate from one another until the report of the sterility test is available. For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous bulk solution should be taken. (7) In the case of parenteral and other sterile products filled aseptically, a Batch Number shall be assigned to all containers filled from one homogenous mix during one filling operation, the filling operation being completed in a period of not more than a day and during which no schedule change in the filling assembly is made. When containers are filled from one homogenous mix, in a number of filling operations, the Batch Number assigned to the containers filled in individual filling operations shall be the same Batch Number as is assigned to the homogenous mix, provided the samples taken from all the different filling operations pass the sterility tests, and are kept separate from one another until the report of the sterility test is available. For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous mix should be taken. (8) In the case of medicinal gases produced by a continuous process of operation a weeks production from one tank load shall be considered as a Batch. (vi) Every drug manufactured in India shall bear on its label the number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words Manufcaturing Licence Number or Mfg. Lic. No. or M.L.; (vii) Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of manufacture, and the date of expiry of potency, and the period between the date of manufacture and the date of expiry shall not exceed that laid down in the said Schedule under the conditions of storage specified

therein. Drugs and their preparations not included in Schedule P shall bear on their labels the date of their manufacture and also the date of their expiry which shall not exceed sixty months from the date of manufacture. Provided that this period may be extended by the Licensing Authority in respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension. (viii) Drugs specified in Schedule C (1) and their preparations including combinations with other drugs shall bear on the labels (a) the date of manufacture, (b) date of expiry of potency fixed by the manufacturer, and (c) where such drugs are imported, also the number of licence under which the drug is imported, preceded by the words Import Licence. Provided that drugs in bulk form included in Schedule C(I) which are not ready for use and not included in Schedule P need not bear on the label the date of expiry of potency. Provided further that no reference shall be made to any other licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter or advertisement enclosed herewith. (ix) Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words Physicians SampleNot to be sold which shall be overprinted. (x) If any preparation contains not less than 3 % by volume of alcohol the quantity of alcohol shall be stated in terms of the average percentage by volume of absolute alcohol in the finished products. (xi)In addition to the other particulars which are required to be printed or written under these rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than 1mm in width and without disturbing the other conditions printed on the label under these rules, namely:Narcotic analgesics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anticancer drugs and all other drugs falling under Schedules G, H, and X whether covered or not in the above list. Provided that the provisions of this clause shall not apply to.(a) preparations intended for animal treatment; (b) preparations intended for external use; (c) Ophthalmic preparations and ear drops; and (d) Sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use. (2) (i) The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R. (ii) The following particulars, in addition to those specified under sub-rule (i) shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container and on every other covering in which the container of a contraceptive, other than a mechanical contraceptive, is packed, namely :---

(a) the date of manufacture; (b) the date upto which the contraceptive is expected to retain its properties; (c) the storage conditions necessary for preserving the properties of the contraceptive upto the date indicated in sub-clause (b). Provided that for oral contraceptives it shall be sufficient to display on the label of the container the date of manufacture only. (3) (i) The particulars prescribed in sub-rule (1) shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein. (ii) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper, case or other covering used solely for the purpose of packing, transport or delivery. (4) Where be any provision of these rules any particulars are required to be displayed on a label on the container, such particulars may, instead of being displayed on a label, be etched, painted or otherwise indelibly marked on the container. Provided that, except where otherwise provided in these rules, the name of the drug or any distinctive letters intended to refer to the drug shall not be etched, painted or otherwise indelibly marked on any glass container other than ampoules. LABELLING OF DISPENSED MEDICINES The label on dispensed medicines has two main functions, one is to uniquely identify the contents of the container, and other is to ensure that patients have clear and concise information. There are both legal and professional requirements, which must be complied between labeling a dispensed medicine. It is the pharmacist responsibility to ensure that these requirements are satisfied and that all labeling is accurate. The regulation indicates the standard details which must appear on even label. Standard Requirements for Labelling Dispensed Medicines All labels must be type written or computer generated. The details, which must appear on the label of a dispensed medicine are(i) The name of the preparation. (ii) The quality. (iii) Instructions for the patient. (iv) The patient name. (v) The date of dispensing. (vi) The name and address of the pharmacy. (vii) Keep out of reach of children. Instructions to the Patient There should be clear and complete instructions to the patient on how to take or use the preparation.

Direction: The phrases such as ` to be taken ` ` to be given ` or ` to be used ` are preferred to `take` `give` `use`. The direction written on the label of a dispensed medicine should be simple and without any confusion. Shake the bottle: The emulsion suspension and aerosols need to be shaken immediately before its use, in order to ensure that the preparation is homogeneous so this instruction must appear on the label of such preparation. Take with water: Mixture, which can cause gastro intestinal irritation, or mixtures for adult patients having a dose 10 ml or more should be diluted with water before taking it. Expiry Date: The expiry date is that point in time when a pharmaceutical product is no longer within acceptable specifications for potency and stability. The date of expiry shall be in terms of month and year and it shall mean that the drug is recommended till the last day of the month. The date of expiry shall be preceded by the words Expiry date. There are however specific occasions when an expiry date must be added to the label. An expiry date should always be put onto any extemporaneously prepared items. An expiry date should always be used when a product has been diluted, thereby affecting the stability and shelf life. An expiry date should always be indicated when the preparation is sterile, e.g. eye drops. Do not use after (date) are preferred methods of expressing expiry dates or EXP 7/09, Expires 7/9. Special Labelling Requirements and Drug Needing Cautionary Labelling Drugs Particulars which should appear on label Schedule G Drugs-If the container of a medicine for internal use contains a substance specified in Schedule G shall be labeled with the words; Caution: it is dangerous to take this preparation except under medical supervision conspicuously printed and surrounded by a line within which there shall be no other words. -Proper name, Manufacturing or import licence No., Batch No., Potency of unit, the date of expiry. -If the container of a medicine for internal use contains a substance specified in Schedule H shall be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words; Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. --If the container of a medicine for internal use contains a substance specified in Schedule H, and comes within the purview of the Narcotic Drugs and Psychotropic Substances Act, 1985 shall be labeled with the symbol NRx which shall be in red and

Schedule G (any Drug)-Schedule H Drugs--

conspicuously displayed on the left top corner of the label, and be also labeled with the following words; Schedule H drug -Warning: -- To be sold by retail on the prescription of a Registered Medical Practitioner only. Schedule X drug--If the container of a medicine for internal use contains a substance specified in Schedule X, shall be labeled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label and be also labeled with the words : Schedule X drug -Warning:-- To be sold by retail on the prescription of a Registered Medical Practitioner only. -Substances specified in Schedule X in bulk form shall bear a label wherein they symbol XRx shall be given conspicuously in red letters. -Proper name of substance in addition to patent or proprietary name, Licence No., Batch No., Lot No., Statements of potency in units, Name and address of the manufacturer of the final product, date of manufacture, A test for maximum toxicity is prescribed a statement that it has passed the test, if any, Date of expiry, Nature and percentage of antiseptics, if any, Precautions necessary for preserving the properties of the drugs.

Schedule X drug (Bulk Form)Schedule C Drugs--

Schedule C1 -The date of manufacture, the date of expiry, import licence no., if Drugs-any. Schedule C1 Drugs and their preparations including combinations with other drugs. Schedule F1-Schedule P Drugs (Any Drugs)-Schedule W Drugs (single Ingradients)-Medicines for Animals F, -The prescribed name. -Date of manufacture, Date of expiry of potency.

-Proper Name (No trade name).

-The container of a medicine made up ready only for treatment of an animal shall be labelled conspicuously with the words Not for

(Veterinary Drugs) Medicines containing methylated spirit Preprations for External applications Non-Sterile Surgical Ligature and Suture--

human use; for animal treatment only and shall bear a symbol depicting the head of a domestic animal. -The container of a medicine prepared for treatment of human ailments shall if the medicine contains industrial methylated spirit, indicate this fact on the label and be labelled with the words FOR EXTERNAL USE ONLY. -The container of a embrocation, liniment, lotion, ointment, antiseptic cream, liquid antiseptic or other liquid medicine for external application shall be labeled with the word in capital FOR EXTERNAL USE ONLY. -Every container of, and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words; Non-sterile surgical ligature (suture) not be used for operations upon the human body unless efficiently sterilized. -For Prophylactic use/ For Therapeutic use.

Patent or Proprietary medicine containing vitamins for prophylactic or therapeutic use--

Mechanical -Perticulars specified in Schedule R, Date of manufacture, Date up contraceptives-- to which it is expected to retain its properties, Storage conditions. Oral -Date of manufacture. ContraceptivesDisinfectants-Alcoholic Preprations (Any drug containing more than 3% v/v alcohol)-Coloured Medicaments--Grade and phenol coefficient and method of use. -Statement of quantity of alcohol as average % of absolute alcohol by volume.

-Common name and % of coloures

Drug samples--

-Drug for free distribution to the medical profession; the words Physicians Sample, Not to be sold.

Special Labelling Instructions for particular type of dispensed dosage form: Name of Preparation Aerosol inhalations Labelling Instructions Applications Capsules Creams Pressurized containers keep away from heat source. Shake before use. Do not exceed the prescribed dose follow the instructions. For external use only. Swallow with a draught of water. For external use only. Store in a cool place. For external use only. Not to be applied on open wound or to raw or weeping surface. For external use only. Shake the bottle before use. For rectal use only. Shake well before use. Warm to body temperature before use. To be used in 30 days after first opening To be used with 24 hrs after first opening. Not to be swallowed in large amounts.

Dusting powders

Ear drops Emulsions Enmos

Eye Drops Eye lotions Gargles and mouth washes

Granules Inhalations

To be dissolved or dispersed in water before taking. Not to be taken. Shake the bottle before use. Not to be swallowed. To be slipped and swallowed slowly without the addition of water. For external use only. Shake the bottle before use. Do not apply on broken skin. Shake the bottle before use. To be taken only after diluting with water. For nasal use only. For external use only. Sterile not to be used be used for injection. For external use only. For vaginal use only. Store in cool place. For external use only. For external use only. For external use only. Sterile not to be used be used for injection. For rectal use only. For rectal use only. Store in a cool place. Dissolve or dispensed in water before taking.

Insufflations Linctuses

Liniments and Lotions

Mixtures

Nasal drops Ointments

Paints Passaries

Pastes Solutions

Suppositories

Tablets

1. For soluble or dispersible tablets 2. For chewable tablets 3. For sustain release, enteric coated or unpleasant tasting tablets. Labelling of Parentrals

Chew before swallowing. Do not crush or chew.

o Parentral containers vary greatly in size from 1ml ampoules to 3 liter bags. It is difficult to put much information on a label intended for a 1ml ampoule and it is not important not to completely obligate the product from view. o The USP states that the label must leave a sufficient area of the container uncovered for its full length of circumference to permit inspection of content. o The BP requires that where appropriate the label must state the strength of the preparation in terms of amount of active ingredient in a suitable dose of volume. The label must also state the name of any added substance, the expiry date and storage conditions. o Statement of storage condition is becoming increasingly important based on the temperature at which long term stability data have been generated. o European regulating authority requires stability data o generated at 25 C and 60% relative humidity. o The FDA currently requires data at 30oC and 60% relative humidity. The requirements vary for different market depending upon the climatic condition. o USP requires more information regarding added substances. It requires the percentage content of each ingredient or the amount of each ingredient in a specified volume. The USP requires the route of administration to be stated. o The BP also has specific requirement for concentrated solution of injection. In this instance the label must state the name of the concentrated solution that the solution must be diluted and the direction for preparation of the injection or infusion. Labeling of Vitamin Containing Products o The vitamin of pharmacopoeial preparation shall be stated on the label in metric units per dose unit. The amount of vitamin A, D and E may be stated in USP units.

o The label of nutritional supplement shall bear on identifying lot number, control number or batch number. Labeling Of Electrolytes The concentration dosage of electrolytes for replacement therapy (ex: Sodium chloride or potassium chloride) shall be stated in the label in milliequivalents (mEq). The label of the product shall indicate also the quantity of ingredients in terms of weight or percentage concentration. Labeling Requirements for Eye Drop and Eye Ointment Container at the Time of Dispensing: S. No Requirement 1 State route of administration 2 Fully identify the product 3 4 5 6 7 8 Statement on preservation Direction for use Statement on in use expiry date Storage requirements Identify patient Date of dispensing Include on label For external use only The name and concentration of active ingredient(s) Confirm presence or absence of preservative Ex: Add one drop to each eye morning and evening. Day, month, year Store in cool place or Protect from light Patients name Day, month, year

Labeling Of Poisons The basic labeling requirements are

The name of the substance. The name, address and telephone number of the supplier. An indication of general nature of the risk ex: toxic, corrosive, teratogenic. The symbols specified foe the above risk ex: skull and cross bones. Risk phrases these are the general statements of properties of the substance ex: cause severe burns.

Safety phrases these contain advice on what to do to avoid problems ex: wear suitable protective clothing, Do not breathe vapor. OTHER PROVISIONS A. Use of letter I.P.; The letters I.P. and recognized abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these rules shall be entered on the label of the drug

only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognized under the Rules. B. Prohibition against altering inscriptions on containers, labels or wrappers of drug; No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug. Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the Licensing Authority. C. Prohibition of sale or distribution unless labeled; Subject to the other provisions of these Rules, no person shall sell or distribute any drug (including a patent or proprietary) unless it is labelled in accordance with these Rules. EXEMPTION Exemption of certain drugs from certain provisions of this Part; (1) Labels on packages or containers of drugs for export shall be adapted to meet the specific requirements of the law of the country to which the drug is to be exported but the following particulars shall appear in a conspicuous position on the innermost container in which the drug is packed and every other covering in which that container is packed: (a) Name of the drug; (b) The name, address of the manufacturer and the number of the licence under which the drug has Been manufactured; (c) Batch or lot number; (d) Date of expiry, if any. Provided that where a drug, not classified under Schedule F, Schedule F(1) and Schedule X, blood products, Narcotic and Psychotropic Substances is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority. (2) A medicine made up ready for treatment, whether after or without dilution, which is supplied on the prescription of a registered practitioner provided that it is labelled with the following particulars: --(a) The name and address of the supplier; (b) The name of the patient and the quantity of the medicine; (c) The number representing serial number of the entry in the prescription register; (d) The dose, if the medicine is for internal use; (e) The words FOR EXTERNEL USE ONLY if the medicine is for external application. PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS

I. AYURVEDIC,SIDDHA AND UNANI DRUGS TECHNICAL ADVISORY BOARD Ayurvedic, Siddha and Unani DTAB is constituted by Central Government Under section 33 C of the Act. (1) The Central Government shall, by notification in the Official Gazette, constitute a Board (to be called the Ayurvedic, Siddha and Unani Drugs Technical advisory Board) to advise the Central Government and the State Governments on technical matters relating to Ayurvedic, Siddha and Unani Drugs. (2) The Board shall consist of the following members, namely: -Ex-officio members(i) the Director General of Health Services, ex-officio; (ii) the Drugs Controller, India ex-officio; (iii) the principal officer dealing with Indian systems of medicine in the Ministry of Health, ex-officio; (iv) the Director of the Central Drugs Laboratory, Calcutta, ex-officio; Nominated member(v) one person holding the appointment of Government Analyst under section 33F,to be nominated by the Central Government; (vi) one Pharmacognocist to be nominated by the Central Government; (vii) one Phyto-chemist to be nominated by the Central Government; (viii) four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of the Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee; (ix)one teacher in Dravyaguna and Bhaishajya Kalpana, to be nominated by the Central Government; (x)one teacher in Ilm-Ul-Advia and Taklis-Wa-Dawa-sazi,to be nominated by the Central Government; (xi) one teacher in Gunapadam to be nominated by the Central Government; (xii) three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government; (xiii) three persons, one each from among the practitioners of Ayurvedic, Siddha and Unani Tibb system of medicine to be nominated by the Central Government. (3) The central Government shall appoint a member of the Board as its Chairman. (4) The nominated members of the Board shall hold office for three years but shall be eligible for renomination. (5) The Board may, subject to the previous approval of the Central Government, make bye- laws fixing a quorum and regulating its own procedure and conduct of all business to be transacted by it. (6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary. II. THE AYURVEDIC, SIDDHA AND UNANI DRUGS CONSULTATIVE COMMITTEE Consultative Committee: The Ayurvedic, Siddha and Unani Drugs Consultative Committee is constituted by Central Government Under section 33 D of the Act. (1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs. (2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned. (3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its own procedure. III. THE AYURVEDIC, SIDDHA AND UNANI GOVERNMENT ANALYSTS A. Government Analysts The Ayurvedic, Siddha and Unani Government Analysts appointed by Central or State Government under section 33F of the Act. (1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such person as it thinks fit, having the prescribed qualification, to be Government Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be. (2) Notwithstanding anything contained in above sub-section, neither the Central Government nor a State Government shall appoint as a Government Analyst any official not serving under it without the previous consent of the Government under which he is serving. (3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section. B. Qualifications A person who is appointed a Government Analyst under section 33 F of the Act shall be a person possessing the qualifications prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani System, as the case may be, conferred by a University, a State Government or Statitory Faculties, Councils and Boards of Indian Systems of Medicine recognized by the Central or State Government, as the case may be, for this purpose and has had not less than three years

post graduate experience in the analysis of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) a Chemical Examiner to Government, or (iii) the Head of an institution specially approved for the purpose by the appointing authority. C. Duties (1) The Government Analyst shall analyze or test or cause to be analyzed or tested such samples of Ayurvedic (including Siddha) or Unani drugs as may be sent to him by Inspectors or any other persons or authority 110uthorized by the Central Government or State Government under the provisions provisions relating to Ayurvedic, Siddha And Unani Drugs of the Act and shall furnish reports of the results of test or analysis in accordance with these rules. (2) A Government Analyst appointed under Section 33F shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publications at the discretion of the Government. D. Procedure Procedure for dispatch of sample to Government Analyst and to receipt by the Government Analyst (1) Sample for test or analysis shall be sent to the Government Analyst by registered post or by hand in a sealed package, enclosed together with a memorandum in Form 18-A in an outer addressed to the Government Analyst. (2) The package as well as the outer cover shall be marked with a distinguishing number. (3) A copy of the memorandum and a specimen impression of the seal used to seal the package shall be sent by registered post or by hand to the Government Analyst. (4) On the receipt of the package from an Inspector, the Government Analyst or an Officer 110uthorized by him in writing in his behalf shall open the package and shall also record the conditions of the seals on the package. (5) After the test or analysis has been completed, one copy of the results of the test or analysis shall be supplied forthwith to the sender in Form 13-A shall also be sent simultaneously to the Controlling Authority and to the Drugs Controller, India. Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs. The method of test or analysis to be employed in relation to an Ayurvedic (including Siddha) or Unani drug shall be such as may be specified in the Ayurvedic, Siddha or Unani Pharmacopoeia, or if no such pharmacopoeias, such tests as the Government Analyst may employ, such tests being scientifically established to determine whether the drug contains the ingredients as stated on the label. IV. THE AYURVEDIC, SIDDHA AND UNANI LICENSING AUTHORITY A. Licensing Authority Any application for the grant or renewal of a licence for import, manufacturing, sale, etc. of Ayurvedic, Siddha and Unani Drugs is to be made to the Licensing Authority.

B. Qualification Qualification of the State Drug Licensing Authority for Licensing of Ayurvdeda, Siddha and Unani drugs: (a) The Ayurvedic/ siddha/ Unani qualifications as per Schedule II of CCIM Act 1970/ B Pharma (Ayurveda of a recognized University). (b) At least 5 years experience in the Ayurveda/ Siddha/ Unani drug manufacturing or testing of Ayurvedic, siddha and Unani drugs or enforcement of provisions relating to Ayurvedic Siddha And Unani Drugs of the Drugs and Cosmetics Act,1940 and Rules made there under or teaching/ research on clinical practice of Ayurveda/ siddha/ Unani System. V. THE AYURVEDIC, SIDDHA AND UNANI INSPECTORS A. Inspectors The Ayurvedic, Siddha and Unani Inspectors appointed by Central or State Government under section 33G of the Act. (1) The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualification, to be Inspectors for such areas as may be assigned to them by Central Government or the State Government as the case may be. (2) The powers which may be exercised by an Inspector and the duties which may be performed by him and the conditions, limitations or restrictions subject to which such powers and duties may be exercised or performed shall be such as may be prescribed. (3) No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be an Inspector under this section. (4) Every Inspector shall be deemed to be a public servant within meaning of section 21 of the Indian Penal Code, 1860 and shall be officially subordinate to such authority as the Government appointing him may specify in this behalf. B. Qualifications A person who is appointed an Inspector under section 33G shall be a person who (a) has the qualifications laid down under rule 49 and shall have undergone practical training in the manufacture of Ayurvedic (including Siddha) or Unani drug, as the case may be; or (b) has a degree in Ayurvedic or Siddha or Unani System or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or State Government or a Statutory Faculty, Council or Board of Indian Systems of Medicine recognized by the Central Government or the State Government for this purpose; or (c) has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be, granted by a State Government or an Institution recognized by the Central Government or a State Government for this purpose. C. Duties Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs

Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs (i) to inspect not less than twice a tear, all premises licensed for manufacture of Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy himself that the conditions of the licence and the provisions of the Act and the Rules made thereunder are being observed; (iii) to take samples of the drugs manufactured on the premises and send them for test or analysis in accordance with these Rules; (iv) to institute prosecutions in respect of violation of the Act and the Rules made thereunder. PROHIBITION OF MANUFACTURE AND SALE OF CERTAIN AYURVEDIC, SIDDHA AND UNANI DRUG A. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug. B. Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani Drug From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall (a) manufacture for sale or for distribution-(i) any misbranded, adulterated or spurious Ayurvedic, Siddha or Unani drugs; (ii) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it; and (iii) any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions related to the Ayurvedic, Siddha or Unani drugs or any rule made thereunder; (b) sell, stock or exhibit or offer for sale or for distribution, any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions related to the Ayurvedic, Siddha or Unani drug, or any rule made thereunder; (c) manufacture for sale or for distribution, any Ayurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this act by the prescribed authority; Provided that nothing in this section apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients; Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis. C. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest

If the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ayruvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug. MANUFACTURE FOR SALE OF AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS Manufacture on more than one set of premises If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate license shall be obtained in respect of each such set of premises. Licensing authorities For the purpose of this part the State Govt. shall appoint such licensing authorities and for such areas as may be specified in this behalf by notification in the Official Gazette. MANUFACTURE LICENCE Application for license to manufacture Ayurvedic (including Siddha) or Unani Drugs (i) An application for the grant or renewal of a license to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the licensing authority along with a fee of rupees sixty. In case of renewal the applicant may apply for the renewal of the license before its expiry or within one month of such expiry. The applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case of fee payable for renewal of such license shall be rupees sixty plus additional fee of rupees thirty. (ii). A fee of rupees fifteen shall be payable for a duplicate copy of a license issued under this rule, if the original license is defaced, damaged or lost. Form of Licence A licence for the grant or renewal of licence for the manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. Conditions for the grant or renewal of a license Before a license in Form 25-D is granted or renewed in Form 26-D the following conditions shall be complied with by the applicant, namely:(i) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in schedule T. (ii) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be conducted under the direction and supervision of competent technical staff consisting at least of one person, who is a whole-time employee and who possesses the following qualifications, namely:-

(a) a degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani systems of medicine, as the case may be, conferred by a University, a State Govt. or Statutory Facilities, Councils and Boards of Indian Systems of Medicine recognized by the Central Govt. or a State Govt. for this purpose, or (b) a diploma in Ayurveda, Siddha or Unani System of medicine granted by a State Govt. or an Institution recognized by the Central Govt. for this purpose, or (c) a graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University recognized by the Central Govt. with experience of at least two years in the manufacture of drugs pertaining to the Ayurvedic or Siddha or Unani system of medicine, or (d) a Vaid or Hakim registered in a State Register of Practitioners of indigenous system of medicines having experience of at least four years in the manufacture of Siddha or Unani drugs, or (e) a qualification as Pharmacist in Ayurvedic (including Siddha) or Unani system of medicine, possessing experience of not less than eight years in the manufacture of Ayurvedic or Siddha or Unani Drugs as may be recognized by the Central Govt. The competent technical staff to direct and supervise the manufacture of Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff to direct and supervise the manufacture of Siddha drugs and Unani drugs shall have qualifications in Siddha or Unani, as the case may be. Conditions of license: A license in Form 25-D shall be subject to the conditions stated therein and to the following further conditions, namely:(a) The license shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products. (b) The license shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the license is issued is carried on, to inspect the premises, to take samples of the raw materials as well as the finished products, and to inspect the records maintained under these rules. (c) The license shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed. Duration of license: An original license in Form 25-D or a renewal license in Form 26-D, unless sooner suspended or cancelled shall be valid up to the 31st December, of the year following the year in which it is granted or renewal. If the application for the renewal of a license is made before is expiry or within one month of its expiry, or if the application is made within three months of its expiry after payment of the additional fee of rupees thirty, the license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired, if application for its renewal is not made within three months of its expiry. LOAN LICENSE

(i) An application for the grant or renewal of loan license to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25-E to the licensing authority along with a fee of rupees thirty. In the case of renewal the applicant may apply for the renewal of the license before its expiry or within one month of such expiry. In the case of renewal the applicant may apply for the renewal one month, but within three months of such expiry in which case the fee payable for renewal of such license shall be rupees thirty plus an additional fee of rupees fifteen. (ii) A fee of rupees seven and paise fifty shall be payable for a duplicate copy of a license issued under this rule, if the original license is defaced, damaged or lost. Form of loan license to manufacture Ayurvedic (including Siddha) or Unani drugs A loan license to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-E. (1) A license under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani system of medicine, as the case may be, which the State Govt. may approve in this behalf. (2) The licensing authority shall, before the grant of a loan license. Satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan license. Conditions of loan license A license in Form 25-E shall be subject to the following further conditions, namely:(a) The license in Form 25-E shall be deemed to be cancelled or suspended, if the license owned by the licensee in Form 25-D whose manufacturing facilities have been availed of by the license is cancelled or suspended, as the case may be, under these rules. (b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV-A of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette. (c) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, of the raw materials and finished products. (d) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose the ascertaining whether the provisions of the Act and the rules have been observed. (e) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed. Duration of loan license

An original loan license in Form 25-E or a renewed loan license in Form 26-E, unless sooner suspended or cancelled, shall be valid up to the 31st December of all year following the year in which it is granted or renewed. If the application for the renewal of a loan license is made in accordance with Rule 153-A, the loan license shall continue to be in force until orders are passed on the application. The license shall be deemed to have expired, if application for its renewal is not made within three months of its expiry. SALE OF AYURVEDIC, SIDDHA OR UNANI DRUGS A licence is not necessary for the sale of any Ayurvedic, Siddha or Unani drugs provide the drugs are manufactured by a person licensed to manufacture under the act. OTHER PROVISIONS RELATED TO THE AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS A. Cancellation and suspension of licenses 1) The licensing authority may, after giving the licensee an opportunity to show cause, within a period which shall not be less than fifteen days from the date of receipt of such notice, why such an order should not be passed, by an order in writing stating the reasons therefore, cancel a license issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the drugs to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the license or with any provisions of the Act or the rules made thereunder. 2) A licensee whose license has been suspended or cancelled may appeal to the State Government within a period of three months from the date of receipt of the order, which shall, after considering the appeal, decide the same. B. Identification of raw materials Raw material used in the preparation of Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are available for their genuineness, and records of such tests as are carried out for the purpose and the methods thereof shall be maintained. C. Confiscation Where any person has been convicted under the Provisions Relating to Ayurvedic, Siddha And Unani Drugs, the stock of the Ayurvedic, Siddha or Unani drug, in respect of which the contravention has been made, shall be liable to confiscation. D. Power of Central Government to make rules The Central Government may, after consultation with, or on the recommendation of, the Board and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the Provisions Relating to Ayurvedic, Siddha And Unani Drugs. Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case, the Board shall be consulted within six months of the making of the rules and the Central Government shall

take into consideration any suggestions which the Board may make in relation to the amendment of the said rules. E. Power to amend First Schedule The Central Government, after consultation with the Board and after giving, by notification in the Official Gazette, not less than three months notice of its intention so to do, may, by a like notification, add to or otherwise amend the First Schedule for the purposes of this Chapter and thereupon the said Schedule shall be deemed to be amended accordingly. OFFENCES AND PENALTIES

PENALTY FOR MANUFACTURE, SALE OF AYURVEDIC, SIDDHA OR UNANI DRUG Whoever himself or by any other person on his behalf (1) manufactures for sale or for distribution,-(a) any Ayurvedic, Siddha or Unani drugs-(i) deemed to be adulterated, or (ii) without a valid licence shall be punishable with imprisonment for a term which may extend to one year and with fine which shall not be less than two thousand rupees; Penalty for subsequent offence; Whoever being convicted of an offence under clause (a) of sub-section (1) is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which may extend to two thousand rupees (2,000 rupees). (b) any Ayurvedic, Siddha or Unani drug deemed to be spurious shall be punishable with imprisonment for a term which shall not be less than 1 year but which may extend to 3 years and with fine which shall not be less than five thousand rupees(5,000 rupees). The Court may, for any adequate and special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than one year and of fine of less than five thousand rupees; or Penalty for subsequent offence; Whoever being convicted of an offence under clause (b) of sub-section (1) is again convicted of an offence under that clause, shall be punishable with imprisonment for a term which shall not be less than 2 years but which may extend to 6 years and with fine which shall not be less than five thousand rupees(5,000 rupees). Provided that the Court may, for any adequate or special reasons to be mentioned in the judgment, impose a sentence of imprisonment for a term of less than 2 years and of fine of less than five thousand rupees (5,000 rupees); (2) contravenes any other provisions of this Chapter or any rule made under this Chapter, shall be punishable with imprisonment for a term which may extend to 3 months and with fine which shall not be less than five hundred rupees (500 rupees).

Penalty for subsequent offence; Whoever being convicted of an offence under sub-section (2) of this section is again convicted of an offence under that sub-section, shall be punishable with imprisonment for a term which may extend to 6 months and with fine which shall not be less than one thousand rupees(1,000 rupees). STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS Standards to be complied with in manufacture for sale or for distribution of Ayurvedic, Siddha and Unani Drugs.Class of Drugs Standards to be complied with 1. Single drugs included in Ayurvedic -The standards for identity, purity and Pharmacopoeia. strength as given in the editions of Ayurvedic Pharmacopoeia of India for the time being in force. 2. Asavas and Arishtas -The upper limit of alcohol as self generated alcohol should not exceed 12% v/v excepting those that are otherwise notified by the Central government from time to time. LABELLING, PACKING AND LIMIT OF ALCOHOL IN AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS LABELLING, PACKING AND LIMIT OF ALCOHOL The container and package of Ayurvedic (including Siddha) or Unani drugs should be labelled with the following particulars; (1) There shall be considerably displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients used in the manufacture of the preparation together with quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule to the Act. Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with packing and reference be made to this effect on the label. (2) The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E (1), be labelled conspicuously with the words Caution: To be taken under medical supervision both in English and Hindi language. (3) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Ayurvedic (including Siddha) or Unani drug and on any other covering in which the container is packed namely--

(i) The name of the drug. For this purpose the name shall be the same as mentioned in the authoritative books included in the Firs Schedule of the Act. (ii) A correct statement of the net content in terms of weight, measure or number as the case may be. The weight and volume shall be expressed in metric system. (iii) The name and address of the manufacturer. (iv) The number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words Manufacturing Licence Number or Mfg. Lic. No. or M.L.. (v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words Batch No. or Batch or Lot Number or Lot No. or Lot No. or Lot or any distinguishing prefix. (vi) The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue. (vii) The words Ayurvedic medicine or Siddha medicine or Unani medicine as the case may be. (viii) The words FOR EXTERNAL USE ONLY if the medicine is for external application. (ix) Every drug intended for distribution to the medical profession, as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words Physicians sample. Not to be sold which shall be over-printed. (4) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper case or other covering used solely for the purpose of packing, transport or delivery. EXEMPTION IN LABELING AND PACKING OF AYURVEDIC (INCLUDING SIDDHA) AND UNANI DRUGS Exemption in labeling and packing, provisions for export of Ayurvedic (including Siddha) and Unani drugs; (1) Labels and packages or containers of Ayurvedic, Siddha and Unani drugs for export may be adapted to meet the specific requirements of the law of the country to which the said drug is to be exported, but the following particulars shall appear in conspicuous position on the container in which drug is packed and on every other covering in which that container is packed, namely: (i) Name of the Ayurvedic, Siddha and Unani drug (Single or compound formulations; (ii) the name, address of the manufacturer and the number of licence under which the drug has been manufactured; (iii) batch or lot number; (iv) date of manufacture, along with the date for Best for use before; (v) main ingredients, if required by the import country; (vi) for export; Provided that where Ayurvedic, Siddha and Unani Single or compound drug not classified under First Schedule or Schedule E-(I), is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or

) i)

containers shall bear a code number as approved by the Licensing Authority menti9oned in Rule 152. (2) the provisions of Rule 161 shall not apply to a medicine made up ready for treatment, whether after, or without, alteration, which is supplied on the prescription of a registered medical practitioner if the medicine is labeled with the following particulars, namely:the name and address of the suppliers; the words For External Use Only, if the medicine is for external application. THE FIRST SCHEDULE A. AYURVEDIC AND SIDDHA SYSTEMS

Serial No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. 41. 42. 43.

Name of book Ayurveda Arogya Kalpadruma Arka Prakasha Arya Bhishak Ashtanga Hridaya Ashtanga Samgraha Ayurveda Kalpadruma Ayurveda Prakasha Ayurveda Samgraha Bhaishajya Ratnavali Brihat Bhaishajya Ratnakara Bhava Prakasha Brihat Nighantu Ratnakara Charaka Samihita Chakra Datta Gada Nigraha Kupi Pakva Rasayana Nighantu Ratnakara Rasa Chandanshu Rasa Raja Sundara Rasaratna Samuchaya Rasatantra Sara Va Siddha Prayoga SangrahaPart 1 Rasa Tarangini Rasa Yoga Sagara Rasa Yoga Ratnakara Rasa Yoga Samgraha Rasendra Sara Samgraha Rasa Pradipika Sahasrayoga Sarvaroga Chikitsa Ratnam Sarvayoga Chikitsa Ratnam Sharangadhara Samhita Siddha Bhaishajya Manimala Sidha Yoga Samgraha Sushruta Samhita Vaidya Chintamani Vaidyaka Shabda Sindu Vaidyaka Chikitsa Sara 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 54A 54B 54C 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84

Name of book Ayurveda Bhelasamhita Vishwanathachikitsa Vrindachikitsa Ayurvedachintamani Abhinavachintamani Ayurveda-Ratnakara Yogaratnasangraha Rasamrita Dravyagunanighantu Rasamanijari Banagasena Ayurvedic Formulary of India (PartI) Ayurveda Sara Samgraha Ayurvedic Pharmacopoeia of India Siddha Siddha Vaidya Thirattu Therayar Maha Karisal Brahma Muni Karukkadai (300) Bhogar (700) Pulippani (500) Agasthiyar Paripuranam (400) Therayar Yamagam Agasthiyar Chenduram (300) Agasthiyar (1500) Athmarakshamrutham Agasthiyar Pin (80) Agasshiyar Rathna Chrukkam Therayar Karisal (300) Veeramamuni Nasa Kandam Agasthiyar (600) Agasthiyar Kanma Soothiram 18 Siddars Chillarai Kovai Yog Vatha Kaviyam Therayar Tharu Agasthiyar Vaidya Kaviyam (1500) Bala Vagadam Chimittu Rathna (Rathna) Churukkam Nagamuni (200) Agasthiyar Chillarai Kovai Chikicha Rathna Deepam Agasthiyar Nayana Vidhi Yugi Karisal (151)

Vidya Jiwan Vasava Rajeeyam Yoga Ratnakara Yoga Tarangini Yoga Chintamani Kashyapasamhita

Agasthiyar Vallathi (600) Therayar Thaila Varkam Siddha Formulary of India (Part I)

B.UNANI TIBB SYSTEM Serial Name of book No.

Serial No.

Name of book

1 2 3 4 5 6 7

Karabadin Qadri Karabadin Kabir Karabadin Azam Ilaj-ul-Amraz Al Karabadin Biaz Kabir Vol. II Karabadin Jadid

8 9 10 11 12 13

Kithalf-ul-Taklis Sanat-ul-Taklis Mifta-ul-Khazain Madan-ul-Aksir Makhzan-ul-murabhat National Formulary of Unani Medicine (Part I)

THE SECOND SCHEDULE STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS MANUFACTURED FOR SALE, VOLD, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED; Class of drug -Patent or proprietary medicines1other than Homoeopathic medicines Standard to be complied with -The formula of list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed. -The standards maintained at the International Laboratory for Biological Standards, Stantans Serum Institute, Copenhagen and at the Central Veterinary Laboratory, Weybridge Surrey, U.K., and such other laboratories recognized by the World Health Organization from time to time, and such further standards of strength, quality and purity, as may be prescribed. -Such standards may be prescribed.

-Substances commonly known as vaccines, sera toxins, toxoids, antitoxins and antigens and biological products of such nature for human use or for veterinary use.

-Substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction or vermin or insect which cause disease in human beings or animals. - Homoeopathic Medicines : (a) Drugs included in the Homoeopathic Pharmacopacia of India.

-Standards of identity, purity and strength specified in the edition of the Homoeopathic Pharmacopoeia of the India for the time being and such other standards as may be prescribed.

(b) Drugs not included in the Homoeopathic Pharmacopoeia of India, but which are included in the Homoeopathic Pharmacopoeia of United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia. (c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America, or the United Kingdom or the German Homoeopathic Pharmacopoeia. -Other drugs (a) Drugs included in the Indian Pharmacopoeia

-Standards of identity, purity and strength prescribed for the drug in the edition of such Pharmacopoeia for the time being in which they are given and such other standards as may be prescribed. -The formula of list of ingredients displayed in the prescribed manner on the label of the container and such other standards as may be prescribed by the Central Government. -Standards of identity, purity and strength specified in the edition of the Indian Pharmacopoeia for the time being in force and such other standards as may be prescribed. In case the standards of identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian pharmacopoeia immediately preceding, the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia and such other standards as may be prescribed.

(b) Drugs not included in the Indian -Standards of identity, purity and strength Pharmacopoeia but not included in the official specified for drugs in the edition of such official Pharmacopoeia of any other country. Pharmacopoeia of any other country for the time being in force and such other standards as may be prescribed. --In case the standards of identity, purity and strength for drugs are not specified in the edition of the official Pharmacopoeia for the time being in force but are specified in the edition immediately preceding, the standards of identity, purity and strength shall be those occurring in such immediately preceding edition of the official Pharmacopoeia and such other standards as may be prescribed.

 PROVISIONS APPLICABLE TO THE HOMOEOPATHIC MEDICINES IMPORT OF HOMOEOPATHIC MEDICINES Homoeopathic system of medicine is about two hundred years old in India first time it was introduces and patronised by Raja Ranjit Singh in 19th century in 1969 first time homoeopathic got a legal status and it was introduces in Drug & Cosmetics Act 1940. The standard of homoeopathic medicines recognized and Drug & Cosmetics Act in June 1978. The Drug & Cosmetics Act regulate the import, manufacturer, distribution and sale of drugs. The Homoeopathic Acts and Rules are firmed by subcommittee of Drugs Technical Advisory Board or Homoeopathy. They government analysts, drug inspectors and import of homoeopathic medicines are governed by the same rule as applicable for modern medicine. Homoeopathic medicines: Homoeopathic medicines include any drug which is recorded in homoeopathy proving or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative homoeopathic literature of India or abroad and which is prepared according to technique of homoeopathic pharmacy and covers combination of ingredients of such homoeopathic medicines but does not include a medicine which is administered by parenteral route. Quality of Drugs: Quality of drugs for import and for manufacture is given in Chapter III (Import of Drugs and Cosmetics) & IV (Manufacture, Sale and Distribution of Drugs and Cosmetics) respectively. As per drugs & Cosmetics Act quality of drugs are given as follows: STANDARDS OF QUALITY: Standard of quality means:(a) in relation to drugs that the drug complies with the standard set out in the (Second Schedule) and, (b) in relation to a cosmetics that the cosmetics complies with such standard as may be prescribed. Standard to be followed: Second Schedule covers the standards to be complied with by imported drugs manufactured for sale, sold, stocked or exhibited for sale or distributed. Homoeopathic medicines are also covered under Second Schedule 4 (A) which are as follows: Class of Drugs (a) Drugs included in the Homoeopathic Pharmacopoeia of India. Standards to be complied with -Standards of identity, purityand strength of drugs given in the Homoeopathic Pharmacopoeia of India for the time being in force and

such other standards as may be prescribed.

(b) Drugs not included in the Homoeopathic Pharmacopoeia of India but which are included in the Homoeopathic Pharmacopoeia of the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia. (c) Drugs not included in the Homoeopathic Pharmacopoeia of India or the United States of America or the United Kingdom or the German Homoeopathic Pharmacopoeia.

-Standards of identity, purity &strength prescribed for the drugs in the edition of such pharmacopoeia for the time being in which they are given and such other standards as may be prescribed. -The formula or list of ingredients displayed in the prescribed manner or the label of the container and such other standards as may be prescribed by the Central Government.

IMPORT OF NEW HOMOEOPATHIC MEDICINE: Rule 30 AA deals with import of Homoeopathic Medicines. (1) No new Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority. (2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it. For the purpose of this rule, New Homoeopathic Medicine means (i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or (ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or (iii)a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended. MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF HOMOEOPATHIC MEDICINES

Applica Licenc Fees for Fee+ Penalty after Category of tion e Fees for Grant / duplicate S.No. expiry but within drugs Form Form Renewal copy of six months No. No. Org. Lic. Rs.200 + Rs. 100 Mother Rs.200+Rs.100p.m. for 1st inspection Tinctures & or part thereof and 24-C 25-C or Rs. 50 in case Rs. 50 1. Potentised inspection fee of Rs. of inspection for Potentised 50 renewal of licence Preparations Rs.200 + Rs. 100 Rs.200+Rs.100p.m. for 1st inspection or part thereof and or Rs. 50 in case Rs. 50 inspection fee of Rs. of inspection for 50 renewal of licence

2.

Potentised Preparation

24-C

25-C

3.

Potentised Preparations from back potencies by Pharmacy 24-C which are licensed to sell Homoeopathic Medicines by retail Additional item

25-C

Rs.200 + Rs. 100 for 1st inspection or Rs. 50 in case of inspection for renewal of licence)

Rs.200+Rs.100p.m. or part thereof and Rs. 50 inspection fee of Rs. 50

4.

Rs. 50 for each additional item

If Homoeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises. Application for licence to manufacture Homoeopathic medicines (1) Application for grant or renewal of licences to manufacture for sale or for distribution of Homoeopathic medicines shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) and shall be made in Form 24-C. (2) The application in Form 24-C shall be accompanied:(a) by a fee of rupees two hundred for the manufacture of Homoeopathic mother tinctures and potentised preparations and an inspection fee of rupees one hundred ten for the first inspection or rupees fifty in case of inspection for renewal of licence;

(b) by a fee of rupees two hundred for the manufacture of Homoeopathic potentised preparations only, and an inspection fee of rupees one hundred for the first inspection or rupees fifty e in case of inspection for renewal of licence; (c) by a fee of rupees two hundred for the manufacture of potentised preparation from back potencies by pharmacies which are already licensed to sell Homoeopathic medicines by retail and an inspection fee of rupees one hundred for the first inspection or rupees fifty in case of inspection for renewal of licence. (3) If a person applies for renewal of a licence after its expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be-(a) rupees two hundred plus an additional fee at the rate of rupees one hundred per month or part thereof and an inspection fee of rupees fifty for the manufacture of Homoeopathic mother tinctures and potentised preparations; (b) rupees two hundred plus an additional fee at the rate of rupees one hundred per month or part thereof and an inspection fee of rupees fifty for the manufacture of Homoeopathic potentised preparations only; (c) rupees two hundred plus an additional fee at the rate of rupees one hundred per month or part thereof and an inspection fee of rupees fifty for the manufacture of Homoeopathic mother tinctures and potentised preparations from back potencies by pharmacies who are already licensed to sell Homoeopathic medicines by retail. (4) A fee of rupees fifty shall be paid for a duplicate copy of the licence for the manufacture of Homoeopathic mother tinctures and potentised preparations issued under sub-rule (1) if the original is defaced, damaged or lost. While the fee to be paid for such a duplicate copy of the licence for the manufacture of Homoeopathic potentised preparations only shall be rupees fifty. (5) Applications by licensee to manufacture additional items of Homoeopathic medicines shall be made to the Licensing Authority and such applications shall be accompanied by a fee of rupees fifty for each additional item. Application to manufacture New Homoeopathic medicines Subject to the other provisions of these Rules____ (1) no New Homoeopathic medicine shall be manufactured unless it is previously approved by the Licensing Authority; (2) the manufacturer of New Homoeopathic medicine, when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it. (3) While applying for a licence to manufacture a New Homoeopathic medicine an applicant shall produce along with his application evidence that the New Homoeopathic medicine for the manufacture of which application is made has already been approved. Form of licence to manufacture Homoeopathic medicines. Licence for manufacture of Homoeopathic medicines is a licence to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail and shall be granted in Form 25-C.

Condition of licence: A licence in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely:(a) the licence shall provide and maintain staff and premises as specified in Rule 85-E. (b) the licence shall allow an (inspector appointed under the act) to enter, with or without prior notice, any premises where the manufacture of a homoeopathic medicine in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured homoeopathic medicines; (c) the licence shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules made thereunder have been observed. (d) the licence shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed; (e) the licence shall comply with the following conditions in respect of the mother tinctures manufactured by him; (i) the crude drug used in the manufacture of the mother tincture shall be identified and records of such identification shall be kept for a period of five years; (ii) the total solids in the mother tincture shall be determined and records of such tests shall be kept for a period of five years; (iii) the alcohol content in the mother tincture shall be determined and records of the same shall be maintained for a period of five years; (iv) the containers of mother tincture shall preferably be of glass and shall be clean and free from any sort of impurities or adhering matter. The glass shall be netural as far as possible. SALE OF HOMEOPATHIC MEDICINES

Fee+ Penalty after Type Application Licence Fees for Category expiry but within Sale Form Form Grant/Renewal six months Whole 19-B 20-D Rs.250 Rs.250+Rs.50 p.m Homoeopathic Sale Medicines Retail 20-C Rs. 250 19-B Rs.250+Rs.50 p.m. Sale

Fees for duplicate copy of Org. Lic. Rs. 50 Rs. 50

SALE:(1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified. (2) Application for the grant or renewal of a licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority and shall be accompanied by a fee of rupees two hundred and fifty; Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry the fee payable for renewal of such licence shall be rupees two hundred and fifty plus an additional fee at the rate of rupees fifty or part thereof.

(3) If the original licence is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of a fee of rupees fifty. A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licences and such other powers, as may be specified, to any other person under his control. Forms of licences to sell drugs A licence to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines by retail or by wholesale shall be issued in Form 20- C or 20-D as the case may be. Condition to be satisfied before a licence in Form 20-C or Form 20-D is granted (1) A licence in Form 20-C or Form 20-D to sell, stock or exhibit or offer for sale or distribute Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are clean and in the case of a licence in Form 20-C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines. Provided that no registered Homeopathic medical practitioner who is practicing Homeopathy in the premises where Homeopathic medicines are sold shall deal in Homeopathic medicines; (2) Any person who is aggrieved by the order passed by the Licensing Authority under subrule (1) may within 30 days from the date the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his case, make such order in relation thereto as it thinks fit. Conditions of licence Licence in Form 20-C or 20-D shall be subject to the conditions stated therein and to the following further conditions, namely:___ (1) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition. (2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines. (3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed. (4) The licensee in Form 20-D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold. (5) The licensee in Form 20-C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparation in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities upto 60 ml. need be maintained. (6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.

 OTHER PROVISIONS RELATED TO THE SALE OF DRUGS A. Duration of licences An original licence or a renewed licence unless it is sooner suspended or cancelled shall be valid for a period of five years on and from the date on which it is granted or renewed If the application for renewal of a licence in force is made before its expiry or if the application is made within six month of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry. B. Cancellation and suspension of licences-(1)The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons here for, cancel a licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder : Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employees, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the Licensing Authority: ___ (i) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or (ii) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or (iii) if the act or omission was a continuing act or omission that he had not or could not reasonably have had knowledge of that previous act or omission, or (iv) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed. (2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same. C. Sale at more than one place If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate licence shall be obtained in respect of each place. D. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force as the case may be, documentary evidence in respect of the ownership or occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any

other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be. E. Labelling Any drug manufactured for the purpose of examination, test or analysis shall be kept in containers bearing labels indicating the purpose for which it has been manufactured. F. Labelling of drugs supplied to other persons If any drug manufactured for the purpose of examination, test or analysis is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the substance if known, or if not known a reference which will enable the substance to the identified and the purpose for which it has been manufactured. LABELLING AND PACKING OF HOMOEOPATHIC MEDICINES Manner of labelling of Homoeopathic medicines (A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed (i) The words Homoeopathic medicine, (ii) The name of the medicine (a) For drugs included in the Homoeopathic Pharmacopoeias of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia. (b) For other drugs, the name descriptive of the true nature of the drug. (iii) The potency of the Homoeopathic medicineFor this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems. (iii-A) In case of Homoeopathic medicine containing two or more ingredients the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label. (iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturerthe name and address of the seller. (v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label. Provided that in case that the total quantity of the pharmacopoeial Homoeopathic medicine in the container is 30 milliliter or less, it will not be necessary to state the content of alcohol in the label. (B) In addition to the above particulars the labels of a Homoeopathic mother tincture shall display the following particulars: -(i) a distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the words Batch No. or Batch or Lot Number or Lot No. or Lot or any distinguishing prefix.

(ii) Manufacturing licence number, the number being preceded by the words Manufacturing Licence Number or Mfg. Lic. No. or M.L.. Explanation: -- This clause shall not apply to a Homoeopathic mother tincture manufactured outside India. (C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label. Prohibition of quantity and percentage No Homoeopathic medicine containing more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospital/dispensaries in packings or bottles of not more than 100 millilitres. PROVISIONS APPLICABLE TO THE COSMETICS Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, permanent waves, colored contact lenses, hair colors, hair sprays and gels, deodorants, baby products, bath oils, bubble baths, bath salts, butters and many other types of products. A subset of cosmetics is called "make-up," which refers primarily to colored products intended to alter the users appearance. Many manufacturers distinguish between decorative cosmetics and care cosmetics. The manufacture of cosmetics is currently dominated by a small number of multinational corporations that originated in the early 20th century, but the distribution and sale of cosmetics is spread among a wide range of different businesses. The U.S. Food and Drug Administration (FDA) which regulates cosmetics in the United States defines cosmetics as: "intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions." This broad definition includes, as well, any material intended for use as a component of a cosmetic product. The FDA specifically excludes soap from this category. Import of Cosmetics All consignments of cosmetics sought to be imported shall be accompanied by an invoice or statement showing the name and quantities of each article of cosmetic included in the consignment and the name and address of the manufacturer. Documents to be supplied to the Collector of Customs Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by on behalf of the importer that the cosmetics comply with the provisions of Chapter III (Provisions related to the import of drugs and cosmetics) of the Act, and the Rules made there under, shall be supplied to the Collector of Customs. Procedure Procedure for the import of cosmetics; If the officer appointed at the post of entry by the Central Government has reason to believe that any cosmetic contravenes any of the provisions of the Act or the rules made

thereunder he may take sample of the cosmetic from the consignment for inspection. If on examination of the sample defects are noticed the officer shall advise the Collector of customs for further action to be taken. If the suspected contravention of the provisions of the Act or the Rules is such as may have to be determined by test, the officer shall send the sample to the laboratory established for the purpose for performing such that the test report on such sample is received from the Director of the said laboratory or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government. If the importer gives an undertaking in writing not to dispose of the cosmetic without the consent of the Collector of Customs and to return the consignment or such portion thereof, he shall return the consignment or such portion thereof as may be required; the Collector of Customs shall make over the consignment to the importer. If the importer who has given an undertaking under the proviso to sub-rule (1) is required by the Collector of Customs to return the consignment or portion thereof, he shall return the consignment or portion thereof within ten days of receipt of the notice. Import Of Cosmetic For Personal Use Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions: (i) The cosmetics shall form part of a passengers baggage and shall be the property of and intended for, the bonafide use of the passenger; and (ii) The cosmetics shall be declared to the Customs authorities, if they so direct. Exemption Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule. OTHER PROVISIONS RELATED TO THE IMPORT OF COSMETICS A. Cosmetic to contain Dyes, Colours and Pigments No Cosmetic shall contain Dyes, Colours and Pigments other than those specified by the Bureau of Indian Standards (IS:4707 Part 1 as amended) and Schedule Q. The permitted Synthetic Organic Colours and Natural Organic Colours used in the Cosmetic shall not contain more than:(i) 2 parts per million of Arsenic calculated as Arsenic Trioxide. (ii) 20 parts per million of lead calculated as lead. (iii)100 parts per million of heavy metals other than lead calculated as the total of the respective metals. B. Import through points of entry No cosmetic shall be imported into India except through the points of entry specified in rule 43A. C. Prohibition of import of cosmetic containing Hexachlorophene No cosmetic containing hexachlorophene shall be imported.

D. Import of cosmetic Lead or Arsenic compound prohibited No cosmetic shall be imported in which a Lead or Arsenic compound has been used for purposes of colouring. E. Import of cosmetics containing mercury compounds prohibited No cosmetic shall be imported which contains mercury compounds. LICENCE TO MANUFACTURE COSMETICS Fee for addl. Fee+ Penalty Fees for Applicatio Licence Fees for Item for more after expiry but duplicate S.No. Particulars n Form Form Grant / than 10 item within six copy of No. No. Renewal for each months Org. Lic. category Lic. Fee of Rs.2500 + insp. Fee of Rs.2500+Rs.400 31 upto 10 Rs.100 for Rs. 1000 p.m. or part items for each additional Own 32 for every thereof in Rs. 250 1. each item subject to manufacturing inspection addition to insp. category a maximum of or for fee of Rs. 1000 Rs.3000 renewal of licence Lic. Fee of Rs.2500 + insp. Fee of Rs.2500+Rs.400 Rs. 1000 p.m. or part for every thereof in Rs. 250 inspection addition to insp. or for fee of Rs. 1000 renewal of licence

2.

31-A upto 10 items 32-A Loan Licence for each category

Rs.100 for each additional item subject to a maximum of Rs.3000

Note: Fee for further application after rejection Rs. 250. MANUFACTURE OF COSMETIC FOR SALE OR FOR DISTRIBUTION If cosmetics are manufactured on more than one premises, a separate application for each such premises shall be made and a separate licence obtained for each such premises. Application for licence to manufacture cosmetics (1) Application for grant or renewal of licence to manufacture any cosmetic for sale shall be made up to 10 items of each category of cosmetics categorized in Schedule M-II to the Licensing Authority appointed by the State Government for the purpose of this Part

(hereafter in this Part referred to as the Licensing Authority) in Form 31 and shall be accompanied by a fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof or for the purpose of renewal of licence. (2) If a person applies for the renewal of licence after expiry but within six months of such expiry, the fee payable for the renewal of such licence shall be rupees two thousand five hundred plus an additional fee at the rate of rupees four hundred per month or part thereof in additional to an inspection fee of rupees one thousand. (3) Application by a licensee to manufacturer additional items of cosmetics shall be accompanied by a fee of rupees one hundred for each item subject to a maximum of rupees three thousand for each application. (4) A fee of rupees two hundred and fifty shall be paid for a duplicate copy of a licence under sub-rule (1) and the proviso to sub-rule (1) respectively if the original is defaced, damaged or lost. Form of licence to manufacture cosmetics for sale or for distribution A licence to manufacture cosmetic for sale or for distribution against application in Form 31, shall be granted in Form 32. Conditions for the grant or renewal of a licence in Form 32 Before a licence in Form 32 is granted or renewed, the following conditions shall be compiled with by applicant: (1) The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole time employee and who possesses any one of the following qualifications: (a) holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948, or . (b) is registered under the Pharmacy Act, 1948, or (c) has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it. (2) The factory premises shall comply with the requirements and conditions specified in Schedule M-II. (3) The applicant shall either-(i) provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture; or (ii) make arrangements with some institution appro ved by the Licensing Authority under Part XV (A) of these rules for such tests to be regularly carried out in this behalf by the institution. LOAN LICENCE Application for loan licence to manufacture cosmetics (1) Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics shall be made up to ten items of each category of cosmetics categorized in Schedule M-II in Form 31-A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspectio n fee of rupees one thousand foe every inspection thereof.

(2) If a person applies for the renewal of a loan licence after the expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be rupees two thousand and five hundred plus an additional fee at the rate of rupees four hundred for each month or part thereof. (3) The Licensing Authority shall before the grant of a loan licence satisfy himself that the manufacturing unit has adequate equipments, staff, capacity for manufacture and facilities to undertake the manufacture on behalf of the applicant for a loan licence. (4) The loan licence shall be granted by the Licensing Authority to only such applicants who propose to avail of the facilities of manufacture of cosmetics in the premises of a manufacturer located in the same State where the applicant is located. In case the manufacture of cosmetic involves any special process of manufacture or use of equipments which are not available in the State where the applicant is located, the Licensing Authority after consulting the Licensing Authority where the manufacturing unit is located, may grant the loan licence. (5) Subject to the provisions of sub-rule (2), application for manufacture of additional items on a loan licence shall be accompanied by fee of rupees one hundred for each item subject to a maximum of rupees three thousand per application. (6) A fee of rupees two hundred and fifty shall be paid for a duplicate copy of a licence issued under sub-rule (1) if the original is defaced, damaged or lost. Form of loan licence to manufacture cosmetics for sale or for Distribution-A loan licence to manufacture cosmetics for sale or for distribution against application in Form 31-A shall be granted in Form 32-A. Conditions of Licence in Form 32-A 1. This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, 1940. 2. Any change in the technical staff shall be forthwith reported to the Licensing Authority. 3. If the licensee wants to manufacture for sale additional items he should apply to the Licensing Authority for the necessary endorsement to the licence as provided in rule 138A (5). This licence shall be deemed to extend to the cosmetics so endorsed. OTHER PROVISIONS RELATED TO THE MANUFACTURE, SALE OF COSMETICS A. Report of result of test or analysis of cosmetics; Test reports on samples of cosmetics taken for test or analysis under these Rules shall be supplied in Form 34. B. Standard for cosmetics; Subject to the provisions of these rules, the standards for cosmetics shall be such as may be prescribed in Schedule S. C.Exemption of cosmetics not manufactured for consumption or sale in India;

From the provisions of this part. - Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adapted to meet the specific requirements, if any, of the consignee. Provided that where a cosmetic is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority. D. Prohibition of sale or distribution; Subject to other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules. LABELLING, PACKING AND STANDARDS OF COSMETICS Manner of labeling Subject to other provisions of the rules, a cosmetic shall carry.(1) On both the inner and outer labels; (a) The name of the cosmetic, (b) The name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured. Provided that if the cosmetic is contained a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code. (2) On the outer labelA declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi solids, combined with numerical court if the content is subdivided: Provided that this statement need not appear in case of a package of perfume, toilet water or the like the net content of which does not exceed 60ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30 grams. (3) On the inner label, where a hazard exists (a) Adequate direction for safe use. (b) Any warning, caution or special direction required to be observed by the consumer, (c) A statement of the names and quantities of the ingredients that are hazardous or poisonous. (4) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter B, provided that this clause shall not apply to any cosmetic containing 10grams or less if the cosmetic is in solid or semi-solid state, and 25 milliliters or less if the cosmetic is in a liquid state. In the case of soaps, instead of the batc h number, the month and year of manufacture of soap shall be given on the label. (5) manufacturing licence number, the number being preceded by the letter M. (6) Where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these Rules.

Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic. Provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority. Labelling of Hair dyes containing Dyes, Colours and Pigments Hair dyes containing Para-Phenylenediamine or other Dyes, Colours and Pigments shall be labeled with the following legend in English and local languages and these shall appear on both the inner and the outer labels. Cautionthis product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying direction should first be made. This product should not be used for dyeing the eye-lashes or eye-brows; as such a use may cause blindness. Each package shall also contain instructions in English and local languages on the following lines for carrying out the test: This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twentyfour hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every applic ation. This preparation should on no account be used for dyeing eye-brows or eye-lashes as severe inflammation of the eye or even blindness may result. Special provisions relating to toothpaste containing fluoride (i) Fluoride content in toothpaste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton. (ii) Date of expiry should be mentioned on tube and carton. IMPORT OF MANUFACTURE OF NEW DRUG FOR CLINICAL TRIALS OR MARKETING Definition Of New Drug For the purpose of this part, new drug shall mean and include.(a) A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labeling thereof and has not been recognized as effective and safe by the licensing authority for the proposed claims. (b) A new drug already approved by the Licensing Authority for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.

(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indic ations, dosage, dosage form (including sustained release dosage form) and route of administration. For the purpose of this rule. (i) all vaccines shall be new drugs unless certified otherwise by the Licensing Authority; (ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier. FORM FORM 44 FORM 45 FORM 45 A FORM 46 Application for grant of permission to import or manufacture a New Drug or to undertake clinical trial. Permission to import Finished Formulation of the New Drug Permission to import raw material (new bulk drug substance) Permission / Approval for manufacture of new drug formulation

Application For Permission To Import New Drug (1) (a) No new drug shall be imported, except under, and in accordance with, the permission granted by the Licensing Authority. (b) An application for the grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees. Provided that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such application shall be fifteen thousand rupees. Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied a fee of fifteen thousand rupees and such information and data as required by Appendix I or Appendix I-A of Schedule Y, as the case may be. (2) The importer of a new drug when applying for permission under sub-rule (1), shall submit data as given in Appendix I to Schedule Y including the results of local clinical trials carried out in accordance with the guidelines specified in that Schedule and submit the report of such clinical trials in the format given n appendix II to the said Schedule. The requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest decide to grant such permission on the basis of data available from other countries. Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in

other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules. (3) the Licensing authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue an import permission in Form 45 and/or Form 45A, subject to the conditions stated therein. Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applic ant in writing, and the conditions, which shall be satisfied before permission could be considered. Conditions for Grant of Approval / Permission in Form 45 Permission to import finished formulation of the new drug shall be issued in Form-45. (1) The formulation shall conform to the specifications approved by the Licensing Authority. (2) The proper name of the drug shall be printed or written in indelible ink and shall appear in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name on the label of the innermost container of the drug or every other covering in which the container is packed. (3) The label of the innermost container of the drug and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and without disturbing the other conditions printed on the label to depict it is prescription drug. (4) The label on the immediate container of the drug as well as the packing in which the container is enclosed should contain the following warning: WARNING : To be sold by retail on the prescription of a Only. (5) Post marketing surveillance study shall be conducted during initial period of two years of marketing of the new drug formulation, after getting the protocol and the names of the investigator duly approved by the Licensing Authority. (6) All reported adverse reactions related to the drug shall be intimated to the Drugs Controller, India and Licensing Authority and regulatory action resulting from their review should be complied with. (7) No claims except those mentioned above shall be made for the drug without the prior approval of the Licensing Authority. (8) Specimen of the carton, labels, package insert that will be adopted for marketing the drug in the country shall be got approved from the Licensing Authority before the drugs is marketed. (9) Each consignment of imported drug shall be accompanied by a test/analysis report. Conditions for Grant of Approval / Permission in Form-45A Permission to import raw material (new bulk drug substance) shall be issued in Form 45A; (1) The raw material (new bulk drug substance) shall conform to the test specifications as approved by the Licensing Authority. (2) For manufacture of raw material (new bulk drug substance) or its formulation in the country, separate approval under rule 122-B shall be obtained from the Licensing Authority.

(3) The permission to import shall not be used to convey or imply that the raw material (new bulk drug) is categorized as life saving or essential drug. APPLICATION FOR APPROVAL TO MANUFACTURE NEW DRUG OTHER THAN THE DRUGS CLASSIFIABLE UNDER SCHEDULES C AND C (1) (1)(a) No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in clause (b) of Rule 21. (b) An application for the grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority and shall be accompanied by a fee of fifty thousand rupees. Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only. Whether in modified dosage form or with the new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees. Any application received after one year of the gran t of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by Appendix 1 or Appendix 1-A of Schedule Y, as the case may be. (2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the Licensing Authority mentioned in the same sub-rule, shall submit data as given in Appendix 1 to Schedule Y including the results of clinical trials carried out in the country in accordance with the guideline specified in Schedule Y and submit the report of such clinical trials in the same format given in Appendix II to the said Schedule. (2-A) The Licensing authorityafter being satisfied that the drug if approved to be manufactured as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46A, as the case may be, subject to the conditions stated therein. The Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered. (3) When applying for approval to manufacture a new drug under sub-rule (1) or its preparations, to the State Licensing Authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved by the Licensing Authority. The requirement of submitting the results of local clinical trials may not be necessary if the drug is of such nature that the Licensing Authority may, in public interest decide to grant such permission on the basis of data available from other countries. The submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carnicogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate polished evidence regarding the safety of the drug, subject to the other provisions of these rules.

Conditions for Grant of Approval / Permission in Form-46 Permission / Approval for manufacture of new drug formulation shall be issued in Form46. (1) The formulation shall conform to the specifications approved by the Licensing Authority. (2) The proper name of the drug shall be printed or written in indelible ink and shall appear in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name on the label of he innermost container of the drug or every other covering in which the container is packed. (3) The label of the innermost container of the drug and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which shall not be less than 1 mm in width and without disturbing the other conditions printed on the label to depict it is prescription drug. (4) The label on the immediate container of the drug as well s the packing in which the container is enclosed should contain the following warning: WARNING : To be sold by retail on the prescription of a . only (5) Post marketing surveillance study shall be conducted during initial period of two years of marketing of the new drug formulation, after getting the protocol and the names of the investigator duly approved by the Licensing Authority. (6) All reported adverse reactions related to the drug shall be intimated to the Drugs Controller, India and Licensing Authority and regulatory action resulting from their review should be complied with. (7) No claims except those mentioned above shall be made for the drug without the prior approval of the Licensing Authority. (8) Specimen of the carton, labels, package insert that will be adopted for marketing the drug in the country shall be got approved from the Licensing Authority before the drug is marketed. Conditions for Grant of Permission / Approval in Form 46-A (1) The raw material (new bulk drug substance) shall conform to the specifications approved by the Licensing Authority. (2) The raw material (new bulk drug substance) can be sold to only those manufacturers who have permission, in writing, from Licensing Authority, either to use the drug for development purpose/clinical trial-bio-equivalence study or to manufacture the formulation. (3) For manufacture of the formulation in the country, separate approval under rule 122-B shall be obtained from the Licensing Authority. PERMISSION TO IMPORT OR MANUFACTURE FIXED DOSE COMBINATION (1) An application for permission to import or manufacture fixed dose combination of two or ore drugs shall be made to the Licensing Authority in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y. (2) The Licensing Authority after being satisfied that the fixed dose combination if approved to be imported or manufactured as finished formulation shall be effective and

safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein. The Licensing authority shall where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered. APPLICATION FOR PERMISSION TO CONDUCT CLINICAL TRIALS FOR NEW DRUG/INVESTIGATIONAL NEW DRUG.(1) No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority. (2) An application for grant of permission to conduct.(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y. (b) exploratory clinical trials (Phase-II) on a new drug shall be made on the basis of data emerging from Phase I trial, accompanied by a fee of twenty five thousand rupees; (c) confirmatory clinical trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from PhaseI also, and shall be accompanied by a fee of twenty five thousand rupees. Provided that no separate fee shall be required to be paid along with application for import/manufacture of a new drug based on successful completion of phases clinical trials by the applicant. Provided further that no fee shall be required to be paid along with the application by Central Government or State Government Institutes involved in clinical research for conducting trials for academic or research purposes. (3) The Licensing Authority after being satisfied with the clinical trials, shall grant permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be, subject to the conditions stated therein. The Licensing Authority shall, where the data provided on the clinical trials is inadequate, intimate the applicant in writing, within six months from the date of such intimation or such extended period, not exceeding a further period of six months, as the Licensing Authority may, for reasons to be recorded in writing, permit, intimating the conditions which shall be satisfied before permission could be considered. For the purpose of these rules Investigational New Drug means a new chemical entity or a product having therapeutic indication but which have never been earlier tested on human beings. OTHER PROVISIONS Suspension or cancellation of Permission/Approval. If the improper or manufacturer under this Part fails to comply with any of the conditions of the permission or approval, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefore, suspend or cancel it.

Appeal Any person aggrieved by an order passed by the Licensing Authority under this Part, may within sixty days from the date of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as is considered necessary, pass such an order in relation thereto as it thinks fit. MISCELLANEOUS PROVISIONS RELATED TO THE DRUD AND COSMETIC ACT AND RULES A. OFFENCES AND PENALTIES I. Offences by companies (1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to the company for the conduct of business of the company, as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence. (2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly: For the purposes of this section-(a) company means a body corporate, and includes a firm or other association of individuals; and (b) director in relation to a firm means a partner in the firm. II. Offences by Government departments Where an offence under Chapter IV (Provisions related to manufacture, sale and distribution of drugs and cosmetics) or Chapter IVA (Provisions related to Ayurvedic, Siddha And Unani Drugs) has been committed by any department of Government, such authority as is specified by the Central Government to be in charge of manufacture, sale or distribution of drugs or where no authority is specified, the head of the department, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. Provided that nothing contained in this section shall render any such authority or person liable to any punishment provided in Chapter1V or Chapter 1VA, as the case may be, if such authority or person proves that the offence was committed without its or his knowledge or that such authority or person exercised all due diligence to prevent the commission of such offence. III. Penalty vexatious search or seizure Any Inspector exercising powers under this Act or the rules made thereunder, who,--

(a) without reasonable ground of suspicion searches any place, vehicle, vessel or other conveyance; or (b) vexatiously and unnecessarily searches any person; or (c) vexatiously and unnecessarily seizes any drug or cosmetic, or any substance or article, or any record, register, document or other material object; or (d) commits, as such Inspector, any other act, to the injury of any person without having reason to believe that such act is required for the execution of his duty, shall be punishable with fine which may extend to one thousand rupees. IV. Publication of sentences passed under this Act (1) If any person is convicted of an offence under this Act, the court before which the conviction takes place shall, on application made to it by the Inspector, cause the offenders name, place of residence, the offence of which he has been convicted and the penalty which has been inflicted upon him, to be published at the expense of such person in such newspapers or in such other manner as the Court may direct. (2) The expenses of such publication shall be deemed to form part of the cost relating to the conviction and shall be recoverable in the same manner as those costs are recoverable. V. Magistrates power to impose enhanced penalties Notwithstanding anything contained the Code of Criminal Procedure, 1973, it shall be lawful for any Metropolitan Magistrate or any Judicial Magistrate of the first class to pass any sentence authorized by this Act in excess of his powers under the said Code. VI. Certain offences to be tried summarily Notwithstanding anything contained in the Code of Criminal Procedure, 1973, all offences under this Act, punishable with imprisonment for a term not exceeding three years, other than an offence under clause (b) of sub-section (1) of section 33I, shall be tried in a summary way by a Judicial Magistrate of the first class specially empowered in this behalf by the State Government or by a Metropolitan Magistrate and the provisions of section 262 to265 (both inclusive) of the said Code shall, as far as may be, apply to such trial. Provided that, in the case of any conviction in a summary trial under this section, it shall be lawful for the Magistrate to pass a sentence of imprisonment for a term not exceeding one year. Provided further that when at the commencement of, or in the course of, a summary trial under this section, it appears to the Magistrate that the nature of the case is such that a sentence of imprisonment for a term exceeding one year may have to be passed or that it is, for any other reason, undesirable to try the case summarily, the Magistrate shall, after hearing the parties, record an order to that effect and thereafter recall any witness who has been examined and proceed to hear or rehear the case in the manner provided by the said Code. B. Protection of action taken in good faith No suit, prosecution or other legal proceeding shall lie against any person for anything which is in good faith done or intended to be done under this Act. C. Rules to be laid before Parliament

Every rule made under this Act shall be laid as soon as may be after it is made before each House of Parliament while it is in session for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified from or be of no effect, as the case may be, so however that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule. D. Power to give directions The Central Government may give such directions to any State Government as may appear to the Central Government to be necessary for carrying into execution in the State any of the provisions of this Act or of any rule or order made thereunder. STANDARDS STANDARDS OF DRUGS (1) Drugs included in the Indian Pharmacopoeia-(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the Indian Pharmacopoeia for the time being in force. (b) In case the standards for identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia. (2) For other drugs (Drugs not included in the Indian Pharmacopoeia)-(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the official pharmacopoeia, for the time being in force, of any country to which the drug claims to comply with, (b) In case the standards for identity, purity and strength for drugs are not specified in the edition of such official pharmacopoeia for the time being in force, but are expected in the edition immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of such official pharmacopoeia to which the drug claims to comply with. (c) For drugs for which standards are not included in the edition of the official pharmacopoeia, for the time being in force, of any country or in edition immediately preceding, but included in the official compendia of drug standards, namely, the British Pharmaceutical Codex or the National Formulary of the United States, for the time being in force, to which the drug claims to comply with. STANDARDS FOR VETERINARY DRUGS For drugs intended for veterinary use, the standards shall be those given in the current edition for the time being in force of the British Pharmacopoeia (Veterinary). STANDARDS FOR PATENT OR PROPRIETARY MEDICINES

The standards for patent or proprietary medicines shall be those laid down in Schedule V and such medicines shall also comply with the standards laid down in the Second Schedule to the Act. STANDARDS FOR SURGICAL DRESSINGS The standards for Surgical Dressing shall be such as are laid down in Schedule F (II). STANDARDS FOR STERILISED UMBILICAL TAPES The standards for Sterilised Umbilical tapes shall be as laid down in Schedule F (III) STANDARDS FOR SUBSTANCES (OTHER THAN FOOD) INTENDED TO AFFECT THE STRUCTURE OR ANY FUNCTION OF HUMAN BODY CONTRACEPTIVES (1) The standards for mechanical contraceptives shall be such as are laid down in Schedule R. (2) The standards which other contraceptives will have to comply with shall be in conformity with the formulae approved as safe and efficacious by the Central Government. Such formula shall be displayed on the label of every container of such contraceptive. STANDARDS FOR MEDICAL DEVICES Tthe standards for the Medical Devices shall be such as are laid down in Schedule R-1. STANDARDS FOR SUBSTANCES INTENDED TO BE USED FOR THE DESTRUCTION OF VERMIN OR INSECTS WHICH CAUSE DISEASE IN HUMAN BEINGS OR ANIMALS DISINFECTANTS The standards of disinfectants shall be such as are laid down in Schedule O. STANDARDS FOR OPHTHALMIC PREPARATIONS INCLUDING HOMOEOPATHIC OPHTHALMIC PREPARATIONS The standards for ophthalmic preparations including Homoeopathic ophthalmic preparations shall be those laid down in Schedule FF., and such preparations shall also comply with the standards set out in the Second Schedule to the Act. LIST OF COLOURS PERMITTED TO BE USED IN DRUGS (A) No drug shall contain a colour other than specified below: -(1) Natural Colours Annatto, Carotene, Chlorophyll, Cochineal, Curcumin, Red Oxide of Iron, Yellow Oxide of Iron, Titanium Dioxide, Black Oxide of iron (2) Artificial Colours Caramel, Riboflavin (3) Coal Tar Colours

GREEN Quinazarine Green S.S., Alizarin Cyanine Green F., Fast Green F.C.F. YELLOW Tartrazine, Sunset Yellow FCF, Quinoline Yellow WS RED Erythrosine, Eosin YS or Eosine G, Toney Red or Sudan III, Ponceau 4 R, Carmoisine BLUE Indigo Carmine, Brilliant Blue FCF ORANGE Orange G BROWN Resorcin Brown BLACK Naphthol Blue Balck (4) LAKES The Aluminum or calcium salts (lakes) of any of the water-soluble colours listed above. (B) The label on the container of a drug containing a permitted colour shall indicate the common name of the colour. SCHEDULES SCHEDULE C AND C1 SCHEDULE C SCHEDULE C (1)

Biological and Special Products

Other Special Products

1. Sera.

1. Drugs belonging to the Digitalis groups and preparations containing drugs belonging to the Digitalis group not in a 2. Solution of serum proteins intended for form to be administered parentally. injection. 3. Vaccines for parenteral injections. 4. Toxins. 5. Antigen. 6. Antitoxins. 4. Fish Liver Oil and preparations 7. Neo-arsphenamine and analogous containing Fish Liver Oil. substances used for the specific treatment 5. Vitamins and preparations containing of infective diseases. any vitamins not in a form to be administered parenterally. 8. Insulin. 6. Liver extract and preparations containing liver extract not in a form to be 10. Adrenaline and Solutions of Salts of administered parenterally. Adrenaline. 7. Hormones and preparations containing 11. Antibiotics and preparations thereof in Hormones not in a form to be administered parenterally. a form to be administered parenterally. 9. Putuitary (Posterior Lobe) Extract. 12 Any other preparation which is meant for parenteral administration as such or after being made up with a solvent or medium or any other sterile product and Which- a)requires to be stored in a refrigerator; or b) does not require to be stored in a refrigerator. 13. Sterilized surgical sterilized surgical suture. 14. Bacteriophages. 15 Ophthalmic preparations. 16 Sterile Disposable Devices for single use only. ligature 8. Vaccine not in a form to be administered parenterally. 9. Antibiotics and preparations thereof not in a form to be administered parenterally. 10. In-vitro Blood Grouping Sera. 3. Adrenaline and preparations containing Adrenaline not in a form to be administered parenterally. 2. Ergot and preparations containing Ergot not in a form to be administered parentally.

and 11. In-vitro diagnostic Devices for HIV, HbsAg and HCV.

 SCHEDULE D: The drugs specified in schedule D are exempted from the provisions regulating import of drugs, as follows: Class of drugs Extent and conditions of exemption - Substances not intended for medicinal --All provisions of Chapter III of the Act use and Rules thereunder subject to the conditions that if the substance is imported in bulk, the importer shall certify that the substance is imported for non-medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or is intended for some purposes other than medicinal use or is intended for some purposes other than medicinal use or is of commercial quality. - The following substances, which are --All provisions of Chapter III of the Actand used both as articles of food as well as Rules there under. drugs: -i.)All condensed or powered milk whether pure, skimmed or malted, fortified with vitamins and minerals. ii)Farex, Oats, Lactose and all other similar cereal preparations whether fortified with vitamins or otherwise excepting those for parenteral use. iii)Virol, Bovril, Chicken essence and all other similar predigested food. iv.)Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specifically labelled as conform - ing to the standards in the Indian Pharmacopoeia or the official pharmacopoeias and the official compendia of the drug standards prescribed under the Act and Rules made thereunder. SCHEDULE E [Omitted as per GOI Notification No.G.S.R. 462(E) dt 22-6-1982] SCHEDULE E (1) List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine

 SCHEDULE G Aminopterin, L-Asparaginase, Bleomycin, Busulphan; its salts, Carbutamide, Chlorambucil;its salts, Chlorothiazide and other derivatives of 1, 2, 4 benzothiadrazine, Chlorpropamide; its salts, Chlorthalidone and other derivatives of Chlorobenzene

compound. (Cis-Platin), Cyclophosphamide; its salts, (Cytarabine), Daunorubicin, DiIsopropyl Eluorophosphate, Disodium Stilboestrol Diphosphate, Doxorubicin Hydrochloride, Ethacrynic acid, its salts, Ethosuximide, Glibenclamide, Hydantoin; its salts, its derivatives, their salts, Hydroxyurea, Insulin all types, Lomustine Hydrochloride, Mannomustine; its salts, Mercaptopurine; its salts, Metformin; its salts, Methsuximide, Mustine, its salts, Paramethadione, Phenacemide, Phenformin; its salts, 5Phenylhydantoin; its alkyl and aryl derivatives, its salts, Primidone, Procarpazine Hydrochloride, Quinthazone, Sarcolysine, Sodium 2 Mercaptoethanesulfonate Tamoxiten Citrate, Testolactone, Thiotepa, Tolbutamide, Tretamine; its salts, Troxidone, Antihistaminic substances the following, their salts, their derivatives, salts of their derivatives., Antazoline, Bromodiphenhydramine, Buclizine, Chlorcyclizine, Chlorpheniramine, Clemizole, Cyproheptadine, Diphenhydramine, Diphenyl pyraline, Doxylamine Succinate, Isothipendyl, Mebhydrolin Napadisylate, Meclozine, Pheniramine, Promethazine, Thenalidine, Triprolidine, Substance being tetra-Nsubstituted derivatives of Ethylene Diamine or Prophylenediamine. Note . Preparations containing the above substance excluding those intended for topical or external use are also covered by this schedule. SCHEDULE H PRESCRIPTION DRUGS Acebutolol Hydrochloride, Aclarubicin Inj, Actilyse, Acyclovir, Adrenocorticotrophic hormone (ACTH), Alclometasone Dipropiponate, Allopurinol, Alphachymotrypsin, Alprazolam, Amantadine Hydrochloride, Amikacin, Amiloride Hydrochloride, Amineptine, Aminoglutethimide Tab, Aminosalicylic Acid, Amiodarone Hydrochloride, Amitriptyline, its salts, Amoscanate, Amoxapine, Amrinone Lactate, Analgin, Androgenic, Anabolic, Oestrogenic and Progestational Substances, Antibiotics, Aprotinin, Organic Compound of Arsenic for injection, Articaine Hydrochloride, Astemizole, Atenolol, Atracrium Besylate Injection, Auranofin, Azathioprine, Barbituric acid, its salts, derivative of Barbituric acid, their salts, Bacampicillin, Benserazide Hydrochloride, Betahistine Dihydrochloride, Bethanidine Sulphate, Bezafibrate, Biclotymol, Biperiden Hydrochloride, Bitoscanate, Bleomycin Oil Suspension, Bromhexine Hydrochloride, Bromocriptine Mesylate, Budesonide, Bupivacaine Hydrochloride, Buspirone, Captopril, Carbidopa, Carbocisteine, Carboplatin Injection, Carboquone, Carisoprodol, L.Carnitine, Cefadroxyl, Cefatoxime Sodium, Cefazolin Sodium, Ceftazidime Pentahydrate, Ceftizoxime Sodium Sterile, Cefuroxime, Cefuroxime Axetil, Centbutindole, Centchroman, Ciclopirox Olamine, Clindamycin, Cimetidine, Cinnarizine, Ciprofloxacin HCL Monohydrate/lactate, Chlordiazepoxide, its salts, Chlormezanone, Chlorpromazine, its salts, Chlorzoxazone, Clavulanic Acid, Clidinium Bromide, Clobetasol Propionate, Clobetazone 17-Butyrate, Clofazimine, Clofibrate, Clonidine Hydrochloride,Clopamide, Clostebol Acetate, Clotrimazole, Codeine, its salts and derivatives, Colchicine, Corticosteroids, their esters, their derivatives and their dosage forms., Cotrimoxazole, Cyclanadelate, Cyclosporin Oral Solution, Danzol, Dapsone, its salts and derivatives, Desogestrol, Dextranomer, Dextropropoxyphene, its salts, Diazepam, Diazoxide, Diclofenac Sodium, Digoxine, Dilazep, Hydrochloride, Diltiazem, Dinoprostone, Diphenoxylate, its salts,

Disopyramide, Domperidone, Dopamine Hydrochloride, Dothiepin Hydrochloride, Doxapram, Hydrochloride, Doxepin Hydrochloride, Econozole, Enalapril Maleate, Enfenamic Acid, Epinephrine, its salts, Epirubicine Inj., Ergot, alkaloids of, whether hydrogenated or not, their homologues, any salt of any substance, falling within this item., Estradiol succinate, Estramustine Phosphate Capsule., Ethacridine Lactate, Ethambutol Hydrochloride, Ethamsylate, Ethinyloestradiol, Ethionamide, Etomidate, Etoposide Cap. & Inj., Farmotidine, Flavoxate Hydrochloride, Flufenamic acid, its salts, its esters, their salts, Flunarizine Hydrochloride, Flupenthixol, Fluphenazine Enanthate and Decanoate, Flurazepam, Flurbiprofen, Flutamide, Fluoxetine Hydrochloride, Galanthamine, Hydrobromide, Gallamine, its salts, its quaternary compound, Gemfibrozil, Genodeoxycholic Acid, Gliclazide, Glucagon, Glycopyrrolate, Glydiazinamide Guanethidine, Gugulipid, Halogenated Hydroxyquinolines, Haloperidol, Heparin, Hepatitis B. Vaccine, Hyaluronidase, Hydrocortisone 17-Butyrate, Hydrotalcite, Hydroxyzine, its salts, Ibuprofen, Imipramine, its salts, Indapamide, Indomethacin, its salts, Insulin Human, Interferon Alpha Inj., Intralipid (intravenous Fat Emulsion), Iohexol Sterile Solution, Iopamidol Sterile Solution, Iopromide, Iron Preparation for parenteral use, Isocarboxazid, Isoflurane, Isonicotinic acid hydrazine and other hydrazine detivatives of isonicotinic acid, their, derivatives, their salts., Isosorbide, Dinitrate, Isosorbide Mononitrate, Isozsurprine, Ketamine Hydrochloride, Ketoconazole, Acetate, Ketoprofen, Labetalol Hydrochloride, Levarterenol, its salts, Levodopa, Lidoflazine, Lithium Carbonate, Lofepramine Decanoate, Loperamide, Lorazepam, Loxapine, Mebendazole, Mebeverine Hydrochloride, Medroxy Progesterone Acetate Tablets, Mefenamic Acid, its salts its ester, their salts, Megestrol Acetate, Meglumine Iocarmate, Melagenina Lotion, Mephenesin, its esters, Mephentermine, Mesterolone, Methicillin, Sodium, Methocarbamol, Metoclopramide, Metoprolol tartarate, Metrizamide, Metronidazole, Mexiletine Hydrochloride, Mianserin Hydrochloride, Miconazole, Minocycline Minoxidil, Mitoxantrone Hydrochloride, Mometasone Furoate, Morphazinamide Hydrochloride, Narcotic Drugs listed in the Narcotic Drugs and Psychtropic Substances Act 1985., Nadolol, Nalidixic Acid, Naproxen, Natamycin, Netilmicin Sulphate, Nicergoline, Nifedipine, Nimustine Hydrochloride, Nitrazepam, Nitroglycerin Injection, Norethisterone Enanthate Injection, Norfloxacin, Ofloxacin, Orphenadrine, its salts, Orthoclone Sterile, Oxazepam, Oxazolidine,its salts, Oxethazaine Hydrochloride, Oxolinic Acid, Oxprenolol Hydrochloride, Oxyfedrine, Oxymetazoline, Oxyphenbutazone, Oxytocin, Ozothine, Pancuronium Bromide, Para amino benzene sulphonamide its salts and derivatives., Para amino Salicylic acid, its salts, its derivatives, D-Penicillamine, Pentazocine, Pentoxiflylline, Pepleomycin Injection., Phenelzine, its salts, Phenothiazine, derivatives of and salts of its derivatives, Phenobarbital, Phenylbutazine, its salts., Pimozide, Pindolol, Piracetam, Piroxicam, Pituitory gland, the active principles of, not otherwise specified in this Schedule and their salts, Polidocanol Injection, Polyestradiol Phosphate Injection, Praziquantel, Prednimustine Tablets, Prednisolone Stearoylglycolate, Prenoxdiazin Hydrochloride, Promazine Hydrochloride, Propafenon Hydrochloride, Propranolol Hydrochloride, Protristyline Hydrochloride, Pyrazinamide, Pyrvinium, its Salts, Quinidne Sulphate, Ranitidine, Rauwolfia alkaloids, their salts,derivatives of the alkaloids of rauwolfia, their salts, Reproterol Hydrochloride, Rosoxacin, Salbutamol Sulphate, Salicylazosulphapyridine, Satranidazole, Septopal Beads & Chains, Serratio Peptidase, Sisomicin Sulphate., Sodium Cromoglyate, Sodium

Hyaluronate Solution, Sodium and Meglumie Iothalamates, Sodium Valproate, Sotalol, Spectinomycin Hydrochloride, Spironolactone, Sucralfate, Sulphadoxine, Sulphamethoxine, Sulphamethoxypyridazine, Sulphaphenazole, Sulprostone Injection, Teratolol Hydrochloride, Terbutaline Sulphate, Terfenadine, Terizione, Testosterone Undecoanoate, Tiaprofenic Acid, Timolol Maleate, Tinazoline, Tinidazole, Thiacetazone, Thiopropazate, its salts, Tobramycin, Tranylcypromine, its salts, Trazodone, Tretinoin, Trifluperazine, Trifluperidol Hydrochloride, Trimetazidine Dihydrochloride, Trimipramine, Tripotassium Dicitrate, Bismuthate, Urokinase, Vasopressin, Vecuronium Bromide Injection, Verapamil Hydrochloride, Xipamide, Zidovudine Cap. NOTE 1. Preparations exempted under proviso to para 2 of Note to Schedule X shall also be covered by this Schedule. 2. Preparations containing the above substances excluding those intended for topical/or external use are also covered by this Schedule. The inclusion of a substance in Schedule H does not imply or convey that substance is exempted from the provisions of Rule 122A. SCHEDULE J Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure. 1. AIDS 2. Angina Pectoris 3. Appendicitis 4. Arteriosclerosis 5. Baldness 6. Blindness 7. Bronchial Asthma 8. Cancer and Benign tumour 9. Cataract 10. Change in colour of the hair and growth of new hair. 11. Change of Foetal sex by drugs. 12. Congenital malformations 13. Deafness 14. Diabetes 15. Diseases and disorders of uterus. 16. Epileptic-fits and psychiatric disorders 17. Encephalitis 18. Fairness of the skin 19. Form, structure of breast 23. Goitre 24. Hernia 25. High/low Blood Pressure 26. Hydrocele 27. Insanity 28. Increase in brain capacity and improvement of memory. 29. Improvement in height of children/adults. 30. Improvement in size and shape of the sexual organ and in duration of sexual performance 31. Improvement in the strength of the natural teeth. 32. Improvement in vision 33. Jaundice/Hepatitis/Liver disorders 34 Leukaemia 36. Maintenance or improvement of the capacity of the human being for sexual pleasure. 37 Mental retardation, subnormalities and growth 38. Myocardial infarction 39. Obesity 40. Paralysis 41. Parkinsonism 42. Piles and Fistulae 43. Power to rejuvinate 44. Premature ageing 45. Premature greying of hair 46. Rheumatic Heart Diseases 47. Sexual Impotence, Premature ejaculation and spermatorrhoea 48. Spondylitis 49. Stammering 50. Stones in gall-

20. Gangrene 21. Genetic disorders 22. Glaucoma

35. Leucoderma

bladder, kidney, bladder 51. Vericose Vein.

SCHEDULE M GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS. To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs and no other manufacturing activity shall be undertaken therein. PART I-A SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS. The general requirements as given in Part 1 of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of sterile products, Parenteral preparations (Small Volume Injectables and Large Volume Parenterals) and Sterile Ophthalmic Preparations. In addition to these requirements, the following specific requirements shall also be followed, namely: -

PART I-B SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES) The General Requirements as given in Part 1 of this Schedule relating to requirements of Good Manufacturing Practices for Premises and materials for pharmaceutical products shall be complied with, mutates mutandis, for the manufacture of oral Solid Dosage Forms (Tablets and Capsules). In addition to these requirements, the following Specific Requirement shall also be followed, namely:PART I-C SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS) The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutates mutandis, for the manufacture of (Syrups, Elixirs, Emulsions and Suspensions). In addition to these requirements, the following Specific Requirements shall also be followed, namely:PART I-D SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, MULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS) Note: - The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutates mutandis, for the manufacture of Topical Products i.e. External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications). In addition to these requirements, following Specific Requirements shall also be followed, namely: 1. The entrance to the area where topical products are manufactured should be through a suitable airlock. Outside the airlock, insectocutors shall be installed. 2. The air to this manufacturing area shall be filtered through at least 20 air filters and shall be air-conditioned. The area shall be ventilated. 3. The area shall be fitted with an exhaust system of suitable capacity to effectively remove vapours, fumes, smoke, floating dust particles. 4. The equipment used shall be designed and maintained to prevent the product from being accidentally contaminated with any foreign matter or lubricant. 5. No rags or dusters shall be used in the process of cleaning or drying the process equipment or accessories used. 6. Water used in compounding shall be Purified Water IP. 7. Powders, wherever used, shall be suitably sieved before use. 8. Heating vehicles and a base like petroleum jelly shall be done in separate mixing area in suitable stainless steel vessels, using steam, gas, electricity, solar energy, etc. 9. A separate packing section may be provided for primary packaging of the products.

PART I-E SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED-DOSEINHALERS (MDI) Note: - The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutates mutandis, for the manufacture of Metered-Dose-Inhalers (MDI). In addition to these requirements, the following Specific Requirements shall also be followed, namely: 1. General Manufacture of Metered-Dose-Inhalers shall be done under conditions which shall ensure minimum microbial and particulate contamination. Assurance of the quality of components and the bulk product is very important. Where medicaments are in suspended state, uniformity of suspension shall be established. 2. Building and Civil Works 2.1. The building shall be located on a solid foundation to reduce risk of cracking walls and floor due to the movement of equipment and machinery. 2.2 All building surfaces shall be impervious, smooth and non-shedding. Flooring shall be continuous and provided with a cove between the floor and the wall as well as the wall to the ceiling. Ceiling shall be solid, continuous and covered to walls. Light fittings and air-grills shall be flush with the ceiling. All service lines requiring maintenance shall be erected in such a manner that these accessible from outside the production area. 2.3. The manufacturing area shall be segregated into change rooms for personnel, container preparation area, bulk preparation and filling area, quarantine area and spray testing and packing areas. 2.4. Secondary change rooms shall be provided for operators to change from factory clothing to special departmental clothing before entering the manufacturing and filling area. 2.5. Separate area shall be provided for de-cartoning of components before they are air washed. 2.6. The propellants used for manufacture shall be delivered to the manufacturing area distribution system by filtering them through 2 filters. The bulk containers of propellants shall be stored, suitably identified, away from the manufacturing facilities. 3. Environmental Conditions 3.1. Where products or clean components are exposed, the area shall be supplied with filtered air of Grade C. 3.2. The requirements of temperature and humidity in the manufacturing area shall be decided depending on the type of product and propellants handled in the facility. Other support area shall have comfort levels of temperature and humidity. 3.3. There shall be a difference in room pressure between the manufacturing area and the support areas and the differential pressure shall be not less than 15 Pascals (0.06 inches or 1.5 mm water gauge). 3.4. There shall be a written schedule for the monitoring of environmental conditions. Temperature and humidity shall be monitored daily.

4. Garments 4.1. Personnel in the manufacturing and filling section shall wear suitable singlepiecegarment made out of non-shedding, tight weave material. Personnel in support areas shall wear clean factory uniforms. 4.2. Gloves made of suitable material having no interaction with the propellants shall be used by the operators in the manufacturing and filling areas. Preferably, disposable gloves shall be used. 4.3. Suitable department-specific personnel protective equipment like footwear and safety glasses shall be used wherever hazard exists. 5. Sanitation 5.1. There shall be written procedures for the sanitation of the MDI manufacturing facility. Special care should be taken to handle residues and rinses of propellants. 5.2. Use of water for cleaning shall be restricted and controlled. Routinely used disinfectants are suitable for sanitizing the different areas. Records of sanitation shall be maintained. 6. Equipment. 6.1. Manufacturing equipment shall be of closed system. The vessels and supply lines shall be of stainless steel. 6.2. Suitable check weights, spray testing machines and labeling machines shall be provided in the department. 6.3. All the equipment shall be suitably calibrated and their performance validated on receipt and thereafter periodically. 7. Manufacture.7.1. There shall be approved Master Formula Records for the manufacture of metered close inhalers. All propellants, liquids and gases shall be filtered through 2 filters to remove particles. 7.2 The primary packing material shall be appropriately cleaned by compressed air suitably filtered through 0.2 filter. The humidity of compressed air shall be controlled as applicable. 7.3. The valves shall be carefully handled and after de-cartoning, there shall be kept in clean, closed containers in the filling room. 7.4. For suspensions, the bulk shall be kept stirred continuously. 7.5. In-process controls shall include periodical checking of weight of bulk formulation filled in the containers. In a two-shot-filling process (liquid filling followed by gaseous filling), it shall be ensured that 100% check on weight is carried out. 7.6. Filled containers shall be quarantined for a suitable period established by the manufacturer to detect leaking containers prior to testing, labeling and packing. 8. Documentation8.1. In addition to the routine good manufacturing practices documentation, manufacturing records shall show the following additional information:(1) Temperature and humidity in the manufacturing area.

(2) Periodic filled weights of the formulation. (3) Records of rejections during on line check weighing. (4) Records of rejection during spray testing. PART I-F SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTIAL INGREDIENTS (BULK DRUGS). The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for premises and Materials for pharmaceutical products shall be complied with, mutates mutandis, for the manufacture of active pharmaceutical ingredients (Bulk Drugs). In addition to these requirements, the following Specific Requirements shall also be followed, namely: 1. Building and Civil Works. 1.1. Apart from the building requirements contained Part-I, General note, the active pharmaceutical ingredients facilities for manufacture of hazardous reactions, BetaLactum antibiotics. Steroids and Steroidal Hormones / Cytotoxic substances shall be provided in confined areas to prevent contamination of the other drugs manufactured. 1.2. The final stage of preparation of a drug, like isolation / filtration / drying / milling / sieving and packing operations shall be provided with air filtration systems including prefilters and finally with a 5 micron filter. Air handling systems with adequate number of air changes per hour or any other suitable system to control the air borne contamination shall be provided. Humidity / Temperature shall also be controlled for all the operations wherever required. 1.3. Air filtration systems including pre-filters and particulate matter retention air filters shall be used, where appropriate, for air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control re-circulation of floating dust particles from production. In areas where air contamination occurs during production, there shall be adequate exhaust system to control contaminants. 1.4. Ancillary area shall be provided for Boiler-house. Utility areas like heat exchangers, chilling workshop, store and supply of gases shall also be provided. 1.5. For specified preparation like manufacture of sterile products and for certain antibiotics, sex hormones, cytotoxic and oncology products, separate enclosed areas shall be designed. The requirements for the sterile active pharmaceutical ingredient shall be in line with the facilities required for formulation to be filled aseptically. 2. Sterile Products. Sterile active pharmaceutical ingredient filled aseptically shall be treated as formulation from the stage wherever the process demands like crystallization, lyophilisation, filtration etc. all conditions applicable to formulations that are required to be filled aseptically shall apply mutates mutandis for the manufacture of sterile active pharmaceutical ingredients involving stages like filtration crystallization and lyophilisation. 3. Utilities / Services. -

Equipment like chilling plant, boiler, heat exchangers, vacuum and gas storage vessels shall be serviced, cleaned, sanitized and maintained at appropriate intervals to prevent mal-functions or contamination that may interfere with safety, identity, strength, quality or purity of the drug product. 4. Equipment Design, Size and Location. 4.1. Equipment used in the manufacture, processing, packing or holding of an active pharmaceutical ingredient shall be of appropriate design, adequate size and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. 4.2. If the equipment is used for different intermediates and active pharmaceutical ingredients, proper cleaning before switching from one product to another becomes particularly important. If cleaning of a specific type of equipment is difficult, the equipment may need to be dedicated to a particular intermediate or active pharmaceutical ingredient. 4.3. The choice of cleaning methods, detergents and levels of cleaning shall be defined and justified. Selection of cleaning agents (e.g. solvents) should depend on : (a) the suitability of the cleaning agent to remove residues of raw materials, intermediates, precursors, degradation products and isomers, as appropriate. (b) whether the cleaning agent leaves a residue itself, (c) compatibility with equipment construction materials like centrifuge / filtration, dryer / fluid bed dryer, rotocone proton dryer, vacuum dryer, frit mill, multi-mill / jet mills / sewetters cut sizing; (d) test for absence of intermediate or active pharmaceutical ingredient in the final rinse. 4.4. Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils used in the manufacture, processing, packing or holding of active pharmaceutical ingredients. These procedures shall include but should not be limited to the following : (a) assignment of responsibility for cleaning and maintaining equipment; (b) maintenance and cleaning program schedules, including where appropriate, sanitizing schedules; (c) a complete description of the methods and materials used to clean and maintain equipment, including instructions for de-assembling and reassembling each article of equipment to ensure proper cleaning and maintenance.; (d) removal or obliteration of previous batch identification; (e) protection of clean equipment from contamination prior to use; (f) inspection of equipment for cleanliness immediately before use; (g) establishing the maximum time that may elapse between completion of processing and equipment cleaning as well as between cleaning and equipment reuse. 4.5. Equipment shall be cleaned between successive batches to prevent contamination and carry-over of degraded material or contaminants unless otherwise established by validation. 4.6. As processing approaches the final purified active pharmaceutical ingredient, it is important to ensure that incidental carry over between batches does not have adverse impact on the established impurity profile. However, this does not generally hold good for any biological, active pharmaceutical ingredient where many of the processing steps

are accomplished aseptically and where it is necessary to clean and sterilize equipment between batches. 5. In-Process Controls. 5.1. In-process control for chemical reactions may include the following: (a) reaction time or reaction completion, (b) reaction mass appearance, clarity, completeness or pH solutions, (c) reaction temperature, (d) concentration of a reactant; (e) assay or purity of the product, (f) process completion check by TLC / any other means. 5.2. In-process control for physical operations may include the following: (a) appearance and colour, (b) uniformity of the blend, (c) temperature of a process, (d) concentration of a solution, (e) processing rate or time, (f) particle size analysis, (g) bulk/tap density, (h) pH determination, (i) moisture content. 6. Product Containers and Closures 6.1. All containers and closures shall comply with the pharmacopoeial or any other requirement, suitable sampling methods, sample sizes, specifications, test methods, cleaning procedures and sterilization procedures, when indicated, shall be used to assure that containers, closures and other component parts of drug packages are suitable and are not reactive, additive, adsorptive or leachable to an extent that significantly affects the quality or purity of the drug. 6.2. The drug product container shall be tested or re-examined as appropriate and approved or rejected and shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which these are unsuitable. 6.3 Container closure system shall provide adequate protection against foreseeable external factors in storage / transportation and use that may cause deterioration or contamination of the active pharmaceutical ingredient. 6.4. Bulk containers and closures shall be cleaned and, where indicated by the nature of the active pharmaceutical ingredient, sterilized to ensure that they are suitable for their intended use. 6.5. The container shall be conspicuously marked with the name of the product and the following additional information concerning : (a) quality and standards, if specified; (b) manufacturing licence number/drug master file number (whichever applicable), batch number; (c) date of manufacture and date of expiry; (d) method for container disposal (label shall give the methodology, if required); (e) storage conditions, if specified and name and address of the manufacturer, if available. 6.6. Areas for different operation of active pharmaceutical ingredients (bulk drugs) section shall have appropriate area which may be suitably partitioned for different operations. PART- II

 SCHEDUE M-I 1. Requirements of factory premises for manufacture of Homoeopathic preparations. (A) Location and surroundings. The factory shall be situated in a place which shall not be adjacent to an open sewage drain, public lavatory or any factory which produces a disagreeable or obnoxious odour or fumes or large quantities of soot, dust or smoke. The factory shall be located in a sanitary place, remove from filthy surroundings. (B) Buildings. The part of the building used for manufacturing shall not be used for a sleeping place and no sleeping place adjoining to it shall communicate therewith except through open air or through an intervening open space. The walls of the room in which manufacturing operations are carried out shall, upto a height of six feet from the floor, be smooth, waterproof and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust. There shall be no chinks or crevices in the walls or floor. The building used for the factory shall be constructed so as to permit production under hygienic conditions laid down in the Factories Act, 1948. (C) Water Supply. The water used in manufacture shall be pure and drinkable quality, free from pathogenic microorganisms. (D) Disposal of waste. There should be adequate arrangement for disposal of wastewater and other residues from the laboratory. The rooms should be airy and clean and the temperature of the room should be moderately comfortable. (E) Health, Clothing and Sanitary requirement of the Staff. All workers shall be free from contagious or obnoxious disease. Their clothing shall consist of a white or coloured uniform suitable to the nature of the work and the climate, and shall be clean. Adequate facilities for personal cleanliness, such as clean towels, soap and hand scrubbing brushes, shall be provided separately for each sex. The workers shall be required to wash and change into clean footwear before entering the rooms where the manufacturing operations are carried on. Workers shall be required to wear either a clean cap or a suitable headgear so as to avoid any possibility of contamination by air or perspiration. (F) Medical services. The manufacturer shall provide adequate facilities for First Aid, Medical inspection of workers at the time of employment and periodically check-up thereafter at least once a year. (G) Working benches. -

Working benches shall be provided for carrying out operations such as filling, labeling, packing etc. such benches shall be fitted with smooth, impervious tops capable of being washed. (H) Container management. Where operations involving use of containers such as bottles, phials and jars are conducted, there shall be adequate arrangements separated from potentisation chamber for washing, cleaning and drying such containers, with suitable equipment for the purpose. Wherever these are attended manually adequate precaution of perfection in respect of cleanliness and avoidance of pollutants shall be taken. 2. Requirements of Plant and Equipment. (A) Mother tinctures. External tinctures and Mother solution section. The following plant and equipment shall be provided namely: (i) Disintegrator, (ii) Sieved Separator, (iii) Balances and fluid measures, (iv) Chopping boards and knives, (v) Macerators with lids, (vi) Percolators with lids and regulated discharge, (vii) Moisture determination apparatus or other suitable arrangement, (viii) Filtering arrangement, (ix) Mixing vessels and suitable non-metallic storage containers, (x) Portable stirrers, (xi) Water still Note: - (1) As for as possible metal contacts may be avoided once the drug is processed. (2) An area of 55 sq. meters is recommended for basic installations. (3) Adequate separate storage facility should be provided for raw material quarantine, storage and bonded room for alcohol were applicable. (4) Separate and suitable storage facility should be provided for fresh herbs and odorous raw materials. (5) Adequate laboratory facility shall be provided for testing of raw material and finished products, (a) Potentisation Section. (1) the following arrangements are recommended for container for closure preparation section namely: (i) Washing tanks with suitable brushing arrangement manual or mechanical, (ii) Purified Water rinsing tan, (iii)Closure macerating or washing tanks, (iv)Drying chambers, An area of 20 sq. meters is recommended for basic installation, (2) The following arrangements are recommended for potency preparation section, namely: (i) Working tables with washable top, (ii) Facilities for separate storage of different grades of back potencies, (iii)Suitable measuring devices for discharge of drug and diluent in potentisation vial, (iv)Potentiser with counter or suitable manual arrangement. Note: - (I) Different droppers shall be used for different drugs potencies, (II) All measuring devices shall be of metric system and be made of glass and shall be free from metallic contents. (III) It is desired that glass droppers etc. intended for re-use after cleaning should be sterilized by autoclave or heating in a hot air oven.

(IV) Plastics, rubber tubes, bulks etc. coming in contact with tinctures or back potencies should not be re-used for other tincture and potencies. (V) Method of potentisation will be adopted as specified in Homoeopathic Pharmacopoeia of India Vol. I (3) Triturating, Tableting and Pill/Globules section (3) The following arrangement are recommended: (i) Triturating machine for suitable device, (iii) Disintegrator, (iv) Mass Mixer, (v) Granulator, (vi) Oven, (vii) Tableting punches or machines, (vii) Kettle (Steam/gas/electrically heated) for preparation solution, (viii) Dryers, (ix) Sieved separator, tablet counters and balances. Note: - Tablet section shall be free from dust and floating particles. An area of 55 sq. meters is recommended for basis installations (4) Ointments and lotion section. The following arrangements are recommended namely: (i) Mixing tank, (ii) Kettle (Steam, gas or electrically heated), (iii)Suitable powder mixer, (iv)Ointment mill, (v)Filling equipment or arrangement, An area of 20 sq. meters is recommended for basic installation. (5) Syrups and tonics: The following arrangements are recommended namely:(i) Mixing and storage tank, (ii) Potable mixer, (iii) Filtering equipment, (iv) Water still / Deioniser, (v) Filling and sealing equipment. An area of 20 sq. meters is recommended for basic installations. (6) Ophthalmic Preparations: The following equipment is recommended for manufacture under aseptic conditions of Eye-Ointments, Eye-Drops, Eye-lotion and other preparations for external use, namely: (i) Hot air even electrically heated with thermostatic control., (ii) Colloid mill or ointment mill, (iii) Kettle (gas or electrically heated) with suitable mixing arrangement, (iv) Tube filling equipment, (v) Mixing and storage tanks of stainless steel or of other suitable material, (vi) Sintered glass funnel, Seitz filter or filter candle, (vii) Liquid filling equipment, (viii) Autoclaves- Adequate precaution should be taken to ensure that the finished product is sterile. An area of 20 Sq. meters is recommended for basic installations. (7) Adequate arrangements for space and equipment should made for labeling and Packing. SCHEDULE M-II REQUIREMENT OF FACTORY PREMISESFOR MANUFACTURE OF COSMETICS. I. GENERAL REQUIREMENTS (A) Location and surroundings. -

The factory shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall not be used for residence or be interconnected with residential area. It shall be well ventilated and clean. (B) Buildings. The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects, rodents, files, etc. The walls of the room in which manufacturing operations are carried out, shall up to a height of six feet from the floor, be smooth, waterproof and capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust. (C) Water supply: The water used in manufacture shall be of potable quality. (D) Disposal of water. Suitable arrangements shall be made for disposal of wastewater. (E) Health, clothing and sanitary requirements of the staff. All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks, headgears, and gloves wherever required. Washing facilities shall also be provided. (F) Medical Services. Adequate facilities for first aid shall be provided (G)Working benches shall be provided for carrying out operations such as filling, labeling, packing, etc. such benches shall be fitted with smooth, impervious tops capable of being washed. (H)Adequate facilities shall be provided for washing and drying of glass containers if the same are to be used for packing the product. II. Requirement of Plant and Equipment The following equipment, area and other requirements are recommended for the manufacture of: A. Powders. Face powder, cake make-up, compacts, face packs, masks and rouges, etc. 1. Equipment. (a) Powder mixer of suitable type provided with a dust collector, (b) Perfume and colour blender, (c) Sifter with sieves of suitable mesh size, (d) Ball mill or suitable grinder, (e) Trays and scoops (stainless steel), (f) Filling and sealing equipment provided with dust extractor, (g) For compacts: -(i) a separate mixer, (ii) compact pressing machine, (h) Weighing and measuring devices, (i) Storage tanks. An area of 15 square meters is recommended. The section is to be provided with adequate exhaust fans.

B. Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams and hair-oils etc. (a) Mixing and storage tanks of suitable materials, (b) Heating kettle steam, gas or electrically heated, (c) Suitable agitator, (d) Colloidal mill or homogeniser (wherever necessary), (e) Triple roller mill (wherever necessary), (f) Filling and sealing equipment, (g) Weighing and measuring devices. An area of 25 square meters is recommended. C. Nail Polishes and Nail lacquers. 1. Equipment: (a) A suitable mixer, (b) Storage tanks, (c) Filling machine hand operated or power driven, (d) Weighing and Measuring devices. An area of 15 square meters is recommended. The section shall be provided with flameproof exhaust system. 2. Premises: The following are the special requirements related to Nail Polishes and Nail Lacquers: (a) It shall be suited in an industrial area, (b) It shall be separate from other cosmeticmanufacturing areas by metal/brick partition up to ceiling, (c) Floors, walls, ceiling and doors shall be fireproof, (d) Smoking, cooking and dwelling shall not be permitted and no naked flame shall be brought in the premises, (e) All electrical writing and connections shall be concealed and main electric, switch shall be outside the manufacturing area, (f) All equipment, furniture and light fittings in the section shall be flameproof, (g) Fire extinguisher like foam and dry powder and sufficient number of buckets containing sand shall be provided, (h) All doors of the section shall open outwards. 3. Storage. All explosive solvents and ingredients shall be stored in metal cupboards or in a separate enclosed area. 4. Manufacture: (a) Manufacture of lacquer shall not be undertaken unless the above conditions are complied with. (b) Workers shall be asked to wear shoes with rubber soles in the section. 5. Other requirements: No objection certificate from the local Fire Brigade Authorities shall be furnished. D. Lipsticks and Lip-gloss 1. Equipment (a) Vertical mixer, (b) Jacketted kettle steam, gas or electrically heated, (c) Mixing vessel (stainless steel), (d) Triple roller mill/Ball mill, (e) Moulds with refrigeration facility, (f) Weighing and measuring devices,. An area of 15 square meters is recommended. E. Depilatories. 1. Equipment:

(a) Mixing tanks, (b) Mixer, (c) Triple roller mill or homogeniser (where necessary), (d) Filling and sealing equipment, (e) Weighing and measuring devices, (f) Moulds (where necessary). An area of 10 square meters is recommended. F. Preparations used for Eyes: Such preparations shall be manufactured under strict hygienic conditions to ensure that these are safe for use. I. Eyebrows, Eyelashes, Eyeliners, etc. 1 Equipment: (a) Mixing tanks, (b) A suitable mixer, (c) Homogeniser (where necessary), (d) Filling and sealing equipment, (e) Weighing and measuring devices. An area of 10 square meters is recommended. II. Kajal and Surma 1. Equipment: (a) Base sterilizer, (b) Powder sterilizer (dry heat oven), (c) Stainless steel tanks, (d) A suitable Mixer, (e) Stainless steel sieves, (f) Filling and sealing arrangements, (g) Weighing and measuring devices, (h) Homogeniser (where necessary), (i) Pestle and Mortar (for Surma). An area of 10 square meters with a separate area of 5 square meters for base sterilization is recommended. Other requirements for I and II (a) False ceiling shall be provided wherever required; (b) Manufacturing area shall be made fly proof. An airlock or an air curtain shall be provided, (c) Base used for Kajal shall be sterilized by heating the base at 150 degree C for required time in a separate enclosed area, (d) The vegetable carbon black powder shall be sterilized in a drying oven at 120 degree C for required time, (e) All utensils used for manufacture shall be of stainless steel and shall be washed with detergent water, antiseptic liquid and again with distilled water, (f) Containers employed for Kajal shall be cleaned properly with bactericidal solution and dried, (g) Workers shall put on clean overalls and use hand gloves wherever necessary. G. Aerosol. 1. Equipment: (a) Air-compressor (wherever necessary), (b) Mixing tanks, (c) Suitable propellant filling and crimping equipments, (d) Liquid filling unit, (e) Leak testing equipment, (f) Fire extinguisher (wherever necessary), (g) Suitable filtration equipment, (h) Weighing and measuring devices,. An area of 15 square meters is recommended. 2. Other requirements: - No objection certificate from the Local Fire Brigade Authorities shall be furnished. H. Alcoholic Fragrance Solutions. Equipment: -

(a) Mixing tanks with stirrer, (b) Filtering equipment, (c) Filling and sealing equipment, (d) Weighing and measuring devices. An area of 15 square meters is recommended. I. Hair Dyes. Equipment: (a) Stainless steel tanks, (b) Mixer, (c) Filling Unit, (d) Weighing and measuring devices. (e) Masks, gloves and goggles. An area of 15 square meters with proper exhaust is recommended. J. Tooth powders and toothpastes, etc. 1. Tooth-powder in General Equipment: (a) Weighing and measuring devices, (b) Dry mixer (powder blender), (c) Stainless steel sieves, (d) Powder filling and sealing equipments. An area of 15 square meters with proper exhaust is recommended. 2. Toothpastes. Equipment: (a) Weighing and measuring devices, (b) Kettle steam, gas or electrically heated (where necessary), (c) Planetory mixer with de-aerator system, (d) Stainless steel tanks, (e) Tube filling equipment, (f) Crimping machine. An additional area of 15 square meters with proper exhaust is recommended. 3. Tooth-powder (Black) Equipment: (a) Weighing and measuring devices, (b) Dry mixer powder blender, (c) Stainless steel sieves, (d) Powder filling arrangements. An area of 15 square meters with proper exhaust is recommended. Areas for manufacturing Black and White tooth powders should be separate. K. Toilet Soaps. 1. Equipment: (a) Kettles/pans for saponification, (b) Boiler or any other suitable heating arrangement. (c) Suitable stirring arrangement, (d) Storage tanks or trays, (e) Driers, (f) Amalgamator /chipping machine, (g) Mixer, (h) Triple roller mill, (i) Granulator, (j) Plodder, (k) Cutter (l) Pressing, stamping and embossing machine, (m) Weighing and measuring devices. A minimum area of 100 square meters is recommended for the small-scale manufacture of toilet soaps. The areas recommended above are for basic manufacturing of different categories of cosmetics. In addition to that separate adequate space for storage of raw materials, finished products, packing materials shall be provided in factory premises. Note No. I. The above requirements of the Schedule are made subject to modification at the direction of the Licensing Authority, if he is of the opinion that having regard to the

nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of a particular case. Note No. II. The above requirements do not include requirements of machinery, equipments and premises required for preparation of containers and closers of different categories of cosmetics. The Licensing Authority shall have the discretion to examine the suitability and adequacy of the machinery, equipments and premises for the purpose of taking into consideration of the requirements of the licence. Note No. III. Schedule M-II specifies equipments and space required for certain categories of cosmetics only. There are other cosmetics items, viz. Attars, perfumes, etc. which are not covered in the above categories. The Licensing Authority shall, in respect of such items orcategories of cosmetics have the discretion to examine the adequacy of factory premises, space, plant and machinery and other requisites having regard to the nature and extent of the manufacturing operations involved and direct the licensee to carry on necessary modification in them. Note No. IV. Areas for formulations meant for external use and areas for formulations meant for internal use shall be separately provided to avoid mix-up even though they are from the same category of formulations SCHEDULE M-III REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES 1. GENERAL REQUIREMENTS 1.1.1. Location and surroundings. The factory building(s) shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall be not used for residence or be interconnected with residence. It shall be well ventilated and clean. 1.1.2. Buildings. The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insets, rodents, flies etc. The walls of the rooms in which manufacturing operations are carried out, shall be up to a height of six feet from the floor, be smooth, water proof and capable of being kept clean. The floor shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust. 1.1.3. Water supply. The water used in manufacture shall be of potable quality. 1.1.4. Disposal of waste. Suitable arrangements shall be made for disposal of wastewater. 1.1.5. Health, Clothing and Sanitation of workers. All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks, headgears and gloves wherever required. Washing facilities shall also be provided.

1.1.6.Medical Services. Adequate facilities for first-aid shall be provided. 1.1.7. Workbenches shall be provided for carrying out operations such as moulding, assembling, labeling, packing etc. such benches shall be fitted with smooth impervious tops capable of being washed. 1.1.8. Adequate facilities shall be provided wherever required for cleaning, washing, drying of different containers of devices. 1.1.9. The premises shall be kept under controlled conditions of temperature and humidity so as to prevent any deterioration in the properties of materials and products due to storage and process conditions. 2. Requirements for Manufacture of Medical Devices.The process of manufacture of medical devices shall be conducted at the licensed premises, wherever required, and shall be divided into the following separate operations/Sections:1) Moulding (wherever manufacture of medical devices is to start from granules), 2) Assembling (include cutting, washing and drying, sealing, packing, labeling, etc.), 3) Raw Materials, 4) Storage Area, 5) Washing, drying and sealing area (wherever required), 6) Sterilization, 7) Testing facilities. The following equipments and space are recommended for the basic manufacture of different categories of medical devices. A. STERILE DISPOSABLE PERFUSION AND BLOOD COLLECTION SETS. (1) Moulding: (a) Injection Moulding Machine, (b) Extruder Machine, (c) PVC Resin compounding Machine, (2) Assembling: (a) Hand Pressing Machine for filter fixing a Drip Chamber, (b) Bag Sealing Machine, (c) Compressor Machine, (d) Leak Testing Bench, (e) PVC Tube Cutting Machine, (f) Tube Winding Machine (wherever necessary), (g) Welding Machine (wherever necessary) An area of 30 square meters for Moulding and 15 square meters for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The moulding section shall, if necessary, have proper exhaust system. Note: - An additional area of 20 square meters is recommended for any extra category. B. STERILE DISPOSABLE HYPODERMIC SYRINGES. (1) Moulding: (a) Granulator, (b) Injection Moulding Machine, (c) Weighing devices, (2) Assembling: (a) Blister Pack Machine, (b) Vacuum Dust Cleaner, (c) Rubber-tip Washing Machine, (d) Foil stamping or screen printing equipment. An area of 30 square meters for moulding and 15 square metres for assembling are recommended for basic installation. The assembling area shall be air-conditioned

provided with HEPA Filters. The moulding section, shall, if necessary, have proper exhaust system. Note: - An additional area of 20 square meters is recommended for any extra category. C. STERILE DISPOSABLE HYPRODERMIC NEEDLES. (1) Moulding: (a) Needle grinding and leveling machine, (b) Electro Polishing Machine, (c) Cutting Machine, (d) Injection Moulding Machine, (e) Needle Pointing Deburrine Machine, (f) Air-compressor, (2) Assembling: (a) Needle cleaning Machine with Magnetic Separator, (b) Blister Packing Machine, (c) Needle Inspection Unit. An area of 30 square meters for Moulding and 15 square meters for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The molding section shall, if necessary, have proper exhaust system. Note: - An additional area of 20 square meters is recommended for any extra category. 3. Raw Materials. The licensee shall keep an inventory of all raw materials to be used at any stage of manufacture of devices and shall maintain records as per Schedule U. All such raw materials shall be identified and assigned control reference umber. They shall be conspicuously labeled indicating the name of the material, control reference number, name of the manufacturer and be specially labeled Under Test or Approved or Rejected. The under test, approved or rejected materials shall appropriately be segregated. These shall be tested for compliance with required standards of quality. A minimum area of 10 Square meters shall be provided for storage of raw materials. 4. Storage Area. The licensee shall provide separate storage facilities for quarantine and sterilized products. An area not less than 10 square metre shall be provided for each of them. 5. Washing, drying and sealing area. The licensee shall provide wherever required adequate equipments like water distillation still, deionizer, washing machine. Dying Oven with trays for washing, drying and sealing of medical device. An area not less than 10 square metre shall be provided. 6. Sterilization. The licensee shall provide requisite equipments with required controls and recording device for sterilization of medical devices by Ethylene Oxide Gas in his own premises or may make arrangements with some Institution approved by the Licensing authority for sterilization. The products sterilized in this manner shall be monitored to assure acceptable levels of residual gas and its degradation products. An area of 10 square meters is recommended for basic installation of such facility. Provided that the above equipment may not be required in case the licensee opts for sterilization of medical devices by Ionising Radiation.

7. Testing Facilities. The licensee shall provide testing laboratory for carrying out Chemical and PhysioChemical testing of medical devices and of raw materials used in its own premises. Provided that the Licensing Authority shall permit the licensee in the initial stage to carry out testing of Sterility, Pyrogens, Toxicity on their products from the approved testing institutions but after one renewal period of licensee shall provide testing facilities of all such tests in their own premises. 8. Records. The licensee shall maintain records of different manufacturing activities with regard to each stage of manufacture in-process control, assembling, packing, batch records for the quantity of devices manufactured from each lot of blended granules, duration of work, hourly quantum of production in respect of each item as well as record of each sterilizing cycle of the gaseous method employed. Note: - The above requirements of machinery, equipments, space, qualifications are made subject to the modification at the discretion of the Licensing Authority, if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of a particular case. SCHEDULE N List of minimum equipment for the efficient runninig of a pharmacy:1. Entrance. - The front of a pharmacy shall bear an inscription Pharmacy in front. 2. Premises. The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and of sufficient dimensions to allow the goods in stock especially medicaments and poisons to be kept in a clearly visible and appropriate manner. The area of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters. The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices. A pharmacy shall be provided with ample supply of good quality water. The dispensing department shall be separated by a barrier to prevent the admission of the public. 3. Furniture and apparatus. The furniture and apparatus of a pharmacy shall be adapted to the uses for which they are intended and correspond to the size and requirements of the establishment. Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust. Every container shall bear a label of appropriate size, easily readable with names of medicaments as given in the Pharmacopoeias.

A pharmacy shall be provided with a dispensing bench, the top of which shall be covered with washable and impervious material like stainless steel, laminated or plastic, etc. A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the work poison in red letters on a white background. Containers of all concentrated solution shall bear special label or marked with the works To be diluted. A Pharmacy shall be provided with the following minimum apparatus and booksecessary for making of official preparations and prescriptions:Apparatus: Balance, dispensing, sensitivity 30 mg., Balance, counter, capacity 3 Kgm., sensitivity 1 gm. Beakers, lipped, assorted sizes Bottles, prescription, ungraduated assorted sizes Corks assorted sizes and tapers. Cork, extracter Evaporating dishes, porcelain. Filter paper Funnels, glass Litmas paper, blue and red Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml Mortars and pestles, glass Mortars and pestles, wedgwood. Ointment pots with bakelite or suitable caps. Ointment slab, porcelain Pipettes, graduated, 2 ml, 5 ml and 10 ml Ring, stand (retort) iron, complete with rings. Rubber stamps and pad Scissors Spatulas, rubber or vulcanite Spatulas, stainless steel. Spirit lamp Glass stirring rods Thermometer, 0oC to 200oC Tripod stand Watch glasses Water bath Water distillation still in case Eye drops and Eye lotions are prepared. Weights, Metric, 1 mg. to 100 gm Wire Gauze Pill finisher, boxwood Pill Machine Pill Boxes Suppository mould Books :

The Indian Pharmacopoeia (current Edition) National Formulary of Indian (Current Edition) The drugs and Cosmetics Act, 1940 The Drugs and Cosmetics Rules, 1945 The Pharmacy Act, 1948 The Dangerous Drugs Act, 1930 4. General provisions. A pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist whose name shall be displayed conspicuously in the premises. The Pharmacist shall always put on clean white overalls. The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean. All records and registers shall be maintained in accordance with the laws in force. Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person. Medicaments when supplied shall have labels conforming to the provisions of laws in force. Note: - The above requirements are subject to modifications at the discretion of the licensing authority, if he is of opinion that having regard to the nature of drugs dispensed, compounded or prepared by the licensee. It is necessary to relax the above requirements or to impose additional requirements in the circumstances of a particular case. The decision of the licensing authority in that regard shall be final. These items are to be provided only by those who intend to dispense pills or suppositories, as the case may be. SCHEDULE S STANDARDS FOR COSMETICS Standards for cosmetics in finished form; The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by the Bureau of Indian Standards (BIS). 1. Skin Powders 2. Skin Powder for infants 3. Tooth Powder 4. Toothpaste 5. Skin Creams 6. Hair Oils 7. Shampoo, Soap-based 8. Shampoo, Synthetic-Detergent based 9. Hair Creams 10. Oxidation hair dyes, Liquid 11. Cologne. 12 Nail Polish (Nail Enamel) 13. After Shave Lotion 14. Pomades and Brilliantines 15. Depliatories chemicals 16 Shaving Creams 17. Cosmetic Pencils 18. Lipstick 19. Toilet Soap 20. Liquid Toilet Soap 21. Baby Toilet Soap 22. Shaving Soap 23. Transparent Toilet Soap 24. Lipsalve IS: 10284 25. Powder Hair Dye IS: 10350 26. Bindi (Liquid) IS: 10998 27. Kum Kum Powde IS: 10999 28. Henna Powder IS: 11142

 SCHEDULE V STANDARDS FOR PATENT OR PROPRIETARY MEDICINES 1. Standards for patent or proprietary medicines, containing vitamins Patent or proprietary medicines containing vitamins for prophylactic, therapeutic or paediatric use shall contain the vitamins in quantities not less than and not more than those specified under the Act and Rules. 2. General Standards for Different Categories of Patent or Proprietary Medicines In the case of Pharmaceutical products containing several active ingredients, the selection shall be such that the ingredients do not interact with one another and do not affect the safety and therapeutic efficacy of the product. The combination shall not also lead to analytical difficulties for the purpose of assaying the content of such ingredient separately. The substances added as additives shall be innocuous, shall not affect the safety or therapeutic efficacy of the active ingredients, and shall not affect the assays and identity tests in the amount present. Subject to the provisions of these rules, patent or proprietary medicines shall comply with the following standards, namely: I. Patent or proprietary medicines shall comply with the general requirements of the dosage from under which it falls as given in the Indian Pharmacopoeia. If the dosage form is not included in the Indian Pharmacopoeia, but is included in any other pharmacopoeia, prescribed for the purpose of the Second Schedule to the Act, it shall comply with the general requirements of the dosage of such pharmacopoeia. Without prejudice to the generality of the foregoing requirements, general requirements shall include compliance with colour consistency, clarity, stability, freedom from contamination with foreign matter or fungal growth, defects like chipping and capping of tablets, cracking of the coating, mottled appearance and other characteristic defects that can be perceived by visual inspection. II. Without prejudice to the generality of the following paras, dosage forms of patent or proprietary medicines shall comply with the following requirements, namely:a) Tablets: Medicines shall comply with requirements for tablets as laid down in the Indian Pharmacopoeia. The nature of coating shall be indicated on the label. Permitted colours may, however, be added and declared on the label. Nature of tablets, such as uncoated, sugar coated or film coated, shall be declared on the label. b) Capsules: Medicines shall comply with the requirements for capsules laid down in the Indian Pharmacopoeia. However, the capsules shall be free from distortion or shape, discolouration and other physical defects like leakage of power from joints, pinholes or cracks in the capsules; c) Liquid oral dosage forms: Emulsions and suspensions shall disperse uniformly on shaking. Homogeneous solutions shall contain no sediments. The volume of the product (net content) in the container shall be not less than the labeled volume. The limit for ethanol content of pharmaceutical products shall be not less than 90 % and not more than 110 % of the labeled contents. d) Injections: Medicines shall comply with the requirements for injections as laid down in the Indian Pharmacopoeia.

e) Ointments: Medicines shall comply with the requirements for injections as laid down in the Indian Pharmacopoeia. III. The contents of active ingredients, other than vitamins, enzymes and antibiotics, in patent or proprietary medicines shall be not less than 90 % and not more than 110 % of the labeled content; however, for enzymes and vitamins, only for lower limit of 90 % shall apply. In all dry formulations containing antibiotics, the limit shall be 90 to 130 % of the labeled contents and in case of liquid antibiotic formulations, the limit shall be 90 to 140 % of labeled contents. Fiducial limits for error for microbiological assay of antibiotics may be estimated depending upon the design of assay procedure. Methods, used for assaying active ingredients shall employ the same basic principles and shall use same organisms as given in the latest edition of the Indian Pharmacopoeia or shall follow any other methods as approved by the authority competent to grant licence to manufacture. IV. All patent or proprietary medicines containing aspirin shall be subjected to Free Salicylic Acid Test and the limit of such acid shall be 0.75 %. Except in case of soluble type aspirin in which case the limit of such acid shall be 3 %. V. Patent or proprietary medicine to be tested for pyrogen shall be tested by injecting into rabbits not less than the human dose of the medicine based on body weight of a 60 kg. human being. Methodology selected shall be indicated in the protocol but the dose shall be not greater than 5 times the human dose based on body weight of 60 kg for man. VI. In injectable patent or proprietary medicines, the test for freedom from toxicity, shall be performed as described in the Indian Pharmacopoeia. Dose selected shall be indicated in the protocol but the dose shall not be less than five times the human dose based on body weight of 60 kg. human being. SCHEDULE W Name of drugs which shall be marketed under generic name only; Analgin, asprin and its salts, Chlorpromazine and its salts, Ferrous sulphate, Piperazine and its salts. SCHEDULE X List of drugs whose import, manufacture & sale, labelling & packaging are governed by special provisions. Amobarbital, Amphetamine, Barbital, Cyclobarbital, Dexamphetamine, Ethclorvynol, Glutethimide, Meprobamate, Methamphetamine, Methylphenidate, Methylphenobarbital, Pentobarbital, Phencyclidine, Phenmetrazine, Secobarbital SCHEDULE Y REQUIREMENT AND GUIDELINES ON CLINICAL TRIALS FOR IMPORT AND MANUFACTURE OF NEW DRUG