DRUGS AND COSMETIC ACT,

1940 AND RULES 1945

History

 British misrule in providing poor health care system to

Indian citizens.
 The observation is made by Drugs Enquiry Committee,
Indian Medical Association
 Reports in Indian Medical Gazette during 1920-1930.
 Then Drugs and Cosmetics Act, 1940 was enacted. The
Rules were framed under this Act in 1945.
OBJECTIVES
 To regulate the import, manufacture, distribution, and sale of drugs
and cosmetics through licensing.

 To regulate manufacture, distribution, and sale of drugs and

cosmetics by qualified persons only.

 To prevent substandard in drugs.

 To regulate the manufacture and sale of Ayurvedic, siddha and

Unani drugs.

 To establish Drugs Technical Advisory Board(DTAB) and Drugs

Consultative Committees(DCC) for allopathic and allied drugs
and cosmetics.
Important Definitions
1. Drug
It Includes:
 All medicines for internal or external use of human beings or animals and
substances 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.
 The substances other than food which may affect the structure or any
function of the human body or the substances used for the destruction of
insects or vermin which cause disease in human beings or animals as
specified from time to time by the Central Government by notification in the
Official Gazette.
 The substances used as components of a drug including, empty
gelatin capsules.

 The devices used 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 Drugs Technical Advisory Board (DTAB).
2. Cosmetic

 It means any article intended to be sprayed, poured, rubbed or sprinkled

on, or introduced into, or applied to the human body or its any part for
cleansing, beautifying, promoting attractiveness or altering the
appearance.

 It also includes any articles intended for use as a component of cosmetic.

3. Ayurvedic, Siddha or Unani Drugs

 These include all medicines used for internal or external purposes or

used 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 Tibby Systems of Medicines specified
in the First Schedule to the Drugs and Cosmetics Act, 1940.
4. Gudakhu

 It is a tobacco product used for rubbing against human teeth. It

contains tobacco powder, lime and molasses along with red mineral matter.
It is a cosmetic within the provisions of the Act.

5. Manufacture

 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;
6. Patent or Proprietary Medicine
It means:
(i) In relation to Ayurvedic, Siddha or Unani System of Medicine, all
formulations containing only such ingredients mentioned in the formulae
described in the authoritative books of Ayurvedic, Siddha or Unani
System of Medicine specified in First Schedule to the Act but does not
include the medicine administered by parenteral route.

(ii) In relation to any other system of medicine including, allopathic, a

drug presented in a form ready for internal or external administration of
human beings or animals and which is not included for the time being in
the editions of Indian Pharmacopoeia or any other Pharmacopoeia.
7. Misbranded Drug
A drug is considered as a misbranded drug:
(i) if it is not labeled in the prescribed manner,
or
(ii) if it is so colored, coated, powdered or polished that damage is
concealed or it is made to appear of better or greater therapeutic
value than it really is,
or
(iii) if the label or container or anything accompanying the drug
bears any statement, design or device which makes any false claim for
the drug or gives misleading information.
7. Adulterated Drug
A drug is considered to be adulterated:
(i) if it consists in whole or in part of any filthy, putrid, or
decomposed substance,
or
(ii) if it has been prepared, packed or stored under poor sanitary
conditions whereby, it may have been contaminated with filth and
rendered injurious to health,
or
(iii) if container of the drug is composed in whole or in part of any
poisonous substance which may render the contents injurious to health,
or
(iv) if it contains a color other than one which is
prescribed,
or
(v) if the drug contains any harmful or toxic substance
which may render it injurious to health,
or
(vi) if the drugs admixed with any substance so as to
reduce its quality or strength.
9. Spurious Drug
A drug is deemed to be a spurious drug:
(i) if it is imported under a name which belongs to another drug,
or
(ii) if it is an imitation of or a substitute for another drug or if it
resembles another drug in a manner likely to deceive or bears upon it or
its label or container the name of another drug,
or
(iii) if it has been substituted wholly or in part by another drug substance,
or
(iv) if it claims to be the product of a manufacturer or company of
whom it is not truly a product.
 SHEDULES TO THE RULES.

Schedule A : Specimens of the prescribed forms for making

application for licenses, issue and renewal of licenses, for
sending memorandum, etc.

Schedule B: Rates of fees for test or analysis by the Central

Drugs Laboratory or the Government Analyst.
Schedule C&CI: List of biological and other special products
whose import, manufacture, sale and distribution are
governed by special provisions.(C-Parenteral, C1-Non
parenteral)

Schedule D: List of drugs that are exempted from certain

provisions that are applicable to the import of drugs.

Schedule E(1): List of poisonous substances under the

Ayurvedic, Siddha and Unani systems of medicine.
Schedule F: Special provisions applicable to blood bank.
Schedule F1: Special provisions applicable to the
production, testing, storage, packing and labelling of
biological and other special products.

Schedule FII: Details of the standards for Surgical

Dressings

Schedule FIII: Details of the standards for Sterilized

Umbical Tapes.
Schedule FF: Details of the standards for Ophthalmic
Preparations.

Schedule G: List of substances that are required to be used

only under medical supervision and which are are required
to be labelled accordingly.

Schedule H: List of substances that should be sold by retail

only on the prescription of a registered medical practitioner.
Schedule J: List of diseases or ailments which a drug may
not purport to prevent or cure.

Schedule K: List of drugs that are exempted from certain

provisions relating to the manufacture of drugs.

Schedule M: Good Manufacturing Practices and

requirements of factory premises, plants and equipments.

Schedule MI: Requirements of factory premises, etc., for

the manufacture of Homoeopathic drugs.
Schedule MII: Requirements of factory premises for the
manufacture of Cosmetics.

Schedule MIII: Requirements of factory premises for the

manufacture of Medical Devices.

Schedule N : List of minimum equipment which a Pharmacy

should possess.

Schedule O : Provisions applicable to Disinfectant Fluids.

Schedule P: Life periods of drugs.

Schedule P1:Contains regulations regarding retail package size of
various drugs.

Schedule Q:List of Coal Tar colors permitted to be used in Cosmetics

Schedule R: Contains various regulations and requirements for

condoms and other mechanical contraceptives.

Schedule S: Standards for cosmetics.

Schedule T: Contains various regulations and requirements for

manufacture of Ayurvedic, Siddha and Unani drugs.
Schedule U: Particulars to be shown in manufacturing and
analytical records of raw materials and drugs.

Schedule U1: Particulars to be shown in manufacturing

analytical records of cosmetics.

Schedule V: Contains standards for drug patents.

Schedule W: Lists generic drugs.

Schedule X: List of drugs whose import, manufacture and sale

labelling and packing are governed by special provisions
(Narcotic and Psychotropic substances).

Schedule Y: Contains requirement and guidelines for clinical

trials.

Schedule Z: Lists of approved drugs for veterinary use.

IMPORT OF DRUGS AND COSMETICS
(eg:- vaccines, sera etc)
• A permit is granted by the licensing authority in specified form.
5.Import of new drugs

 No new can be imported except with written permission

of the Licensing authority.

 While applying for such a permission , all documentary

and other evidence relating to the standards of quality,
purity and strength etc. should be supplied to the
Licensing authority as provided in Schedule Y .
 PROCEDURE FOR IMPORT

 No drug can be imported unless it is packed or labelled in

prescribed manner.
 All consignment of drugs to be imported should be
accompanied by an invoice or other statement with address
of manufacture, name and quantity of drugs
 Before importing any drug which a license is not required, a
declaration signed by the manufacturer on the behalf of the
importer that the drug is complied with act and rules, should
be supplied to the Customs Collector.
 If the Custom Collector has reason to doubt whether any
drugs comply with provisions of the Act and Rules or if
requested by an officer appointed for this purpose by
Central Government, the Customs Collector 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.

 Customs Collector may also detain consignments of drugs

of which samples have been taken, until report of sample is
received.
 If the report of analysis indicates that the sample of drug is
not of standard quality or contravenes any provision of the
act or the rules and the contravention cannot be remedied
by the importer, the Custom Collector may direct the
importer to export the consignment back to the
manufacturer abroad within 2 months or forfeit the same to
the central government for destruction.

 If the contravention is such that it can be remedied by the

importer, the Custom Collector Shall permit the importer to
import.
C. SUBSTANCES EXEMPTED FROM THE PROVISIONS RELATED
TO IMPORT OF DRUGS
D. PLACES THROUGH DRUGS MAY BE IMPORTED INTO INDIA

0
10,000 Rs
 MANUFACTURE OF DRUGS
The following licenses are granted for the manufacturing of drugs
under D and C Act and Rules.

1. Manufacturing of drugs belonging to Schedules C and C (I)

2. Manufacturing of drugs belonging to Schedule X
3. Manufacturing of drugs belonging to Schedules C, C (I) and X
4. Manufacturing of drugs other than Schedule C, C(1), and X
5. Manufacturing of drugs for examination, test or analysis
6. Loan licenses
7. License for Repacking.
CONDITIONS FOR GRANT LICENCE

(i) A graduate in Pharmacy/ Pharmaceutical Chemistry with a

minimum of 18 months of experience after graduation. The duration
may be reduced by 6 months, if the applicant has undergone training
during graduation. or

(ii)A graduate in Science with Chemistry as a principal subject and with

3 years of manufacturing experience after graduation or

(iii) A graduate in Chemical Engineering or Chemical Technology or

Medicine with 3 years of manufacturing experience after graduation
or

(iv) Holding equivalent foreign qualification.

5.The applicant should provide adequate staff, premises
and laboratory equipment for carrying tests of the
strength and purity of the substances.

6. The applicant shall provide adequate space, plant

and equipment, for manufacturing operations as given
in Schedule M
CONDITIONS TO BE FULFILLED AFTER GETTING A
LICENSE (CONDITIONS OF LICENCE)

 The manufacturer should always maintain adequate staff, sufficient

premises and equipment.

 The manufacturing records, records for raw material and analysis

and other operational records should be maintained as per Schedule
'U’.

 The licensee should own an analytical laboratory or get tested

the samples analyzed in an approved analytical laboratory.

 The records for analysis are required to be maintained for a period

of 5 years from date of manufacturing.
 The manufacturer should allow the Inspector to inspect the
premises, manufacturing process, analytical procedures, and
withdraw the samples. The manufacturer should also withdraw the
batch manufactured by him if directed to do so by the Controlling
Authority.

 The manufacturer should comply with all the requirements of the

Act and Rules thereunder.

 The manufacturer should maintain the Inspection Book.

 Samples with expiry date should be maintained for 6 months after
expiry date. For other categories, the samples should be maintained
for 3 years from the date of manufacturing. Twice the lot of
reference samples should be maintained. The quantity maintained
should be sufficiently available for analysis.

 Any change in the staff structure especially, technical staff should be

reported to Licensing Authority.

 Any major structural change in the premises should be done with the
permission of Licensing Authority

 The manufacturer should forward all the sales records to the

Controlling Authority.
C. MANUFACTURE OF DRUGS UNDER SCHEDULES C
AND C (1), DRUGS UNDER SCHEDULE X AND DRUGS
SPECIFIED IN SCHEDULES C, C (1) AND X

 Application for grant or renewal of a license is made for Schedules C

and C (1) drugs in Form-27 and for Schedules C, C (1) and X in Form
27-B. The license is issued in Form-28 for manufacture of Schedules C
and C (1) drugs and in Form 28-B for drugs under Schedules C, C (I)
and X.
 The license for schedule X drugs not including C and C1 is issued in
Form 25F
CONDITIONS FOR LICENCE

 The licensee shall comply with requirements of space, plant,

equipment, etc., should be as per Schedule M.

 The applicant shall provide staff, premises and laboratory

equipment for carrying out such tests for strength, quality, and
purity of the substances as under the rules including proper
housing for animals.
 The competent technical persons should be available with one of the
following qualifications.

 A graduate in Pharmacy/Pharmaceutical Chemistry with 18 months

of experience after graduation in manufacturing drugs to which
license applies. Six months of mandatory training after graduation can
form part of this total training of 18 months.
or
 A graduate in Science with Chemistry or Microbiology as major
subject with a minimum of 3 years of experience after graduation in
the manufacture of drugs to which this license applies.
or
 A foreign equivalent qualification.
Or

 For manufacture of veterinary Scheduled drug formulations, a

graduate in Medicine/Veterinary Science/General Science/
Pharmacy with minimum 3 years experience in manufacture of
biological products.
 There should be facilities available for storage of drugs.
 Sufficient precaution should be taken for preserving the properties of
manufactured drugs.
 The applicant shall furnish to the LA if required, data on the
stability of drugs.
 CONDITIONS OF LICENCE

 The licensee shall provide and maintain adequate staff and adequate
premises and plant for the proper manufacturing and storage of
substances.

 Records of manufacturing should be maintained as per Schedule 'U'.

Records of test, analysis and examination and batch wise records are
required to be maintained. All records should be kept for a period of 2
years from the date of expiry of drug. In other cases, with no expiry
date, the records should be kept for 5 years from the date of
manufacturing.
 The manufacturer should allow the Inspector or the representative
of Controlling Authority and Licensing authority to visit
manufacturing premises with or without notice.

 The manufacturer should report to the Licensing Authority any

changes in staff or any material changes.

 The licensee should furnish the sample of drugs to the Inspector

when asked for purpose of analysis. He should not sell the drug if
asked to do so by Controlling Authority and withdraw the drug
already sold from the market on direction from the Authority

 The licensee should maintain the Inspection Book to enable the

Inspector to record his observations.
 The Licensee shall from time to time inform the LA any changes
in the expert staff and material changes in the premises or plant
since the date of last inspection made on behalf of the LA before
issue of license.

 No drug manufactured under the license shall be sold unless the

precautions necessary for preserving its properties have been
observed throughout the period after manufacture.

 The licensee shall comply with the requirements of the Act and
rules and any additional requirements which may be specified.
 The licensee shall maintain reference sample from each
batch of drugs manufactured by him in a twice quantity
than that sufficient for conducting all the tests

 Accounts of all transactions regarding manufacturing

should be maintained in serially bound and paged
register(preserved for 5 years)
D. MANUFACTURE OF DRUGS FOR TESTING,
ANALYSIS OR EXAMINATION

 A license is necessary to manufacture of drug in small quantity for

the purpose of test or analysis.

 If the manufacturer does not hold license to manufacture drugs

specified in C and C1 or to manufacture drugs other than those
specified in Schedule C, C1 and X, he shall obtained a license in
obtained in Form 29.

 The validity of the license is for I year.

CONDITIONS OF LICENSE

 The manufactured drugs should be kept in containers bearing

appropriate label indicating the purpose of test or analysis.
 The licensee shall use manufactured drugs under the license
exclusively for the purpose of examination, test, or analysis and shall
carry on the manufacture and examination, or test or analysis at the
place specified in the license.
 The manufacturer should allow the Inspector to inspect the premises,
manufacturing, and analytical records and withdraw the samples if
required for analysis.
 The manufacturer should comply with the provisions of the Act and
Rules.
 The manufacturer should maintain an Inspection Book and the same
be shown to the Inspector.
MANUFACTURE OF NEW DRUGS
NEW DRUG

 A new drug is a substance of chemical, biological, or

biotechnological origin, in bulk or prepared dosage form
used for prevention, diagnosis, or treatment of disease in
man or animal which except during local clinical trials,
has not been used in the country to any significant extent
and which, except during local clinical trials, has not
been recognized in the country as effective and safe for
proposed claims.
 A drug already approved by the LA for certain claims, which
is now proposed to be marketed with modified or new claims
namely indications, dosage form, dosage, and route of
administration.

 A fixed dose combination of two or more drugs individually

approved earlier for certain claim, 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 indications,
dosage, dosage forms and route of administration.
PROVISIONS FOR THE MANUFACTURE OF NEW DRUGS

 No new drug can be manufactured unless prior approval of the

licensing authority is taken.

 A manufacturer of new drug, when applying for approval, shall

submit data as given in Appendix 1 to Schedule Y including the
results of clinical trials carried out in the country as per format
given in Appendix 11 to Schedule Y

 While applying for a license to manufacture new drug or its

preparation an applicant shall produce along with his application
evidence that the drug has already been approved.
E. LOAN LICENCE

A Loan license means a license which a

licensing authority issue to an applicant who
does not have his own arrangements for
manufacturing but who indents to avail himself
of manufacturing facilities owned by another
licensee.
 Thelicensee shall satisfy all conditions for the
manufacture of respective drugs except that he
may not have his own arrangement for the
manufacture of drugs.
 Before the grant of loan license the licensing
authority shall get the premises inspected by one
or more inspectors with or without expert in the
concerned field.
 Theinspector shall examine all portions of the
premises, plant and appliances, process of
manufacture.
 He shall also inquire about qualification of technical
staffs employed and capability of the applicant to
comply the requirements of technical staff and the
requirements of plant and equipment as laid down in
Schedule M.
 For manufacturing of additional items on loan
license, an application shall be made to the licensing
authority.
 The licensee is required to test all the raw
materials and finished product and maintain the
relevant record as specified in Schedule U
 Such records shall be maintained for a period of
5 years from the manufacture or 2 years from the
date of expiry
 If the license of parent firm cancelled or
suspended, the loan license also deemed to be
cancelled or suspended
a)A person who holds an approved Diploma in Pharmacy or
is a registered pharmacist or
b) A person who has passed the intermediate examination
with chemistry as one of the principal subjects or an equalent
recognized examination or
c)A person who has passed the matriculation or equalent
recognized examination and has at least 4 years practical
experience in the manufacture, dispensing, or repacking of
drugs
 The factory premises shall comply with the conditions
prescribed in Schedule M
 The licensee shall make adequate arrangement for the
storage of drugs
 The licensee shall comply with the provisions of act and
the rules and with such further requirements as may be
specified
 The licensee shall allow any inspector to enter and
inspect with or without prior notice and to withdraw
samples
 The licensee shall maintain inspection book to enable
inspector to record his impression and defects noticed
 The licensee shall maintain reference sample from each
batch of drugs manufactured by him in a twice quantity
than that sufficient to do all tests.
 The license remain valid up to December 31st
 Apart from other particulars in label, the label on the
repacked drugs shall mention the name, and address of
the licensee, and his license number preceding by the
word “Rpg. Lic. No”