THE DRUGS AND COSMETICS ACT, 1940

[Act 23 of 1940 as amended up to Act 26 of 2008]

[10th April, 1940]

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;

And whereas the Legislatures of all the Provinces have passed resolutions in
terms of Section 103 of the Government of India Act, 1935 (26 Geo. 5, c. 2.), in relation
to such of the above-mentioned matters ancillary thereto as are enumerated in List II of
the Seventh Schedule to the said Act;

It is hereby enacted as follows:-

CHAPTER I
INTRODUCTORY

1. Short title, extent and commencement. (1) This Act may be called the Drugs and
Cosmetics Act, 1940.

(2) It extends to the whole of India.

(3) It shall come into force at once; but Chapter-III shall take effect only from such date
as the Central Government may, by notification in the Official Gazette, appoint in this
behalf, and Chapter IV shall take effect in a particular State only from such date as the
State Government may, by like notification, appoint in this behalf :

Provided that in relation to the State of Jammu and Kashmir, Chapter III shall
take effect only from such date after the commencement of the Drugs and Cosmetics
(Amendment) Act, 1972, as the central Government may, by notification in the Official
Gazette, appoint in this behalf.

2. Application of other laws not barred. – The provisions of this Act shall be in
addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and any other law
for the time being in force.

3. Definitions. – In this act, unless there is anything repugnant in the subject or context, -

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(a) “Ayurvedic, Siddha or Unani] drugs" 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 formulate described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb
system of medicine, specified in the First Schedule;

(aa) "the Board" means—

(i) in relation to Ayurvedic, Siddha or Unani drug, the Ayurvedic, Siddha and Unani
Drugs Technical Advisory Board constituted under section 33C ; and

(ii) in relation to any other drug or cosmetic, the Drugs Technical Advisory Board
constituted under-section 5;

(aaa) "cosmetic" means any article intended to be rubbed, poured sprinkled or sprayed
on, or introduced into, or otherwise applied 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 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
the human body or intended to be used for the destruction of "vermins" 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

the Central Government or a State Government under section 33F; 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;

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(d) omitted.

(e) "Inspector" means—

(i) in relation to Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central
Government or a State Government under section 33G; and

(ii) in relation to any other drug or cosmetic, an Inspector appointed by the Central
Government or a State Government under Section 21;

(f) "manufacture" in relation to any drug or cosmetic includes any process or part of a
process for making, altering, ornamenting, finishing, packing, labeling, 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 ;

(g) "to import", with its grammatical variations and cognate expressions means to bring
into India;

(h) "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 formulate 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 parental
route and also a formulation included in the authoritative books as specified in clause (a);

(ii) in relation to any other systems of medicine, a drug which is a remedy or 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 the Indian Pharmacopoeia for the time
being or any other pharmacopoeia authorised in this behalf by the Central Government
after consultation with the Drugs Technical Advisory Board constituted under section 5;

(i) "prescribed" means prescribed by rules made under this Act.

3A. Construction of references to any law not in force or any functionary not in
existence in the State of Jammu and Kashmir. – Any reference in this Act to any law
which is not in force, or any functionary not in existence, in the State of Jammu and
Kashmir, shall, in relation to that State, be construed as a reference to the corresponding
law in force, or to the corresponding functionary in existence, in that State.

4. Presumption as to poisonous substances. – Any substance specified as poisonous by

rule made under Chapter II or Chapter or Chapter IVA shall be deemed to be a poisonous
substance for the purpose of Chapter III or Chapter IV or Chapter IV-A, as the case may
be.

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 CHAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS
LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE

5. The Drugs Technical Advisory Board. – (1) The Central Government shall, as soon
as may be, 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 the following members, namely,

(i) the Director General of Health Services, ex officio, who shall be Chairman;

(ii) the Drugs Controller, India ex officio ;

(iii) the Director of the Central Drugs Laboratory, Calcutta, ex-officio;

(iv) the Director of the Central Research Institute, Kasauli, ex-officio;

(v) the Director of the Indian Veterinary Research Institute, Izatnagar, ex-officio ;

(vi) the President of the Medical Council of India, ex-officio;

(vii) the President of the Pharmacy Council of India, ex-officio ;

(viii) the Director of the Central Drug Research Institute, Lucknow, ex-officio;

(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 pharrmacologist 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;

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(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:

Provided that the person nominated or elected, as the case may be, under clause
(ix) or clause (x) or clause (xi) of clause (xvi) of sub-section (2) shall hold office for so
long as he holds the appointment of the office by virtue of which he was nominated or
elected to the Board.

(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.

6. The Central Drugs Laboratory. – (1) The Central Government shall, as soon as may
be, 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 or any
rules made under this Chapter:

Provided that, if the Central government so prescribes, the functions of the

Central Drugs Laboratory in respect of any drug or class of drugs or cosmetic or class of
cosmetics 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 class of drugs or such 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 –

(a) the functions of the Central Drugs Laboratory;

(b) omitted.

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(c) omitted.

(d) the procedure for the submission of the said Laboratory under Chapter IV or Chapter
IV-A of samples of drugs or cosmetics for analysis or test, the forms of the Laboratory’s
reports thereon and the fees payable in respect of such reports;

(e) such other matters as may be necessary or expedient to enable the said Laboratory to
carry out its functions ;

(f) the matters necessary to be prescribed for the purposes of the proviso to sub-section
(1).

7. The Drugs Consultative Committee. – (1) The Central Government may constitute
an advisory committee to be called "the Drugs Consultative Committee" to advise the
Central Government, the State Governments and the Drugs Technical Advisory Board on
any matter tending to secure uniformity India in the administration of this Act.

(2) The Drugs Consultative Committee shall consist of two representatives of the Central
Government to be nominated by that Government and one representative of each State
Government to be nominated by the State Government concerned.

(3) The Drugs Consultative Committee shall meet when required to do so by the Central
Government and shall have power to regulate its own procedure.

7-A. Section 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs. – Nothing
contained in sections 5 and 7 shall apply to Ayurvedic, Siddha or Unani drugs.

CHAPTER III
IMPORT OF DRUGS AND COSMETICS

8. Standards of quality. – (1) For the purposes of this Chapter, the expression "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 complies 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 be a like notification add to or otherwise amend the Second Schedule, for the
purposes of this Chapter, and thereupon the Second Schedule shall be deemed to be
amended accordingly.

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9. Misbranded drugs. – For the purposes of this Chapter, a drug shall be deemed to be
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 labeled in the prescribed manner; or

(c) if its label or contained or anything accompanying the drug bears any statement,
design or device which is false or misleading in any particular.

9-A. Adulterated drugs. – For the purposes of this Chapter, a drug shall be deemed to
be 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.

9B. Spurious drugs. – For the purposes of this Chapter, a drug shall be deemed to be
spurious, -

(a) if it is imported under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in
a manner likely to deceive or bears upon it or upon its label or contained 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 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

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(e) if it purports to be the product of a manufacturer of whom it is only truly a product.

9C. Misbranded Cosmetics. – For the purposes of this Chapter, a cosmetic shall be
deemed to be misbranded –

(a) if it contains a colour which is not prescribed ; or

(b) if it is not labeled in the 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.

9D. Spurious cosmetics. – For the purposes of this Chapter, a cosmetic shall be deemed
to be spurious, -

(a) if it is imported under a 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 and conspicuously marked so as to reveal
its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a 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.

10. Prohibition of import of certain drugs or cosmetics. – 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 cosmetics;

(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;

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(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 or
use under the directions indicated or recommended;

(f) any drug or cosmetic the import of which is prohibited by rule made under this
Chapter:

Provided that 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:

Provided further that 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 import of any drug or class of drugs not being of standard quality.

10-A. Power of Central Government to prohibit import of drugs and cosmetics 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 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.

11. Application of law relating to sea customs and powers of Customs Officers. – (1)
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 Chapter, 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.

(2) Without prejudice to the provisions of sub-section (1), the Commissioner of Customs
or any officer of the Government authorised 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 Chapter 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.

12. Power of Central Government to make rules. – (1) The Central Government may,
after consultation with or on the recommendation of the Board and after previous

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publication by notification in the Official Gazette, make rules for the purpose of giving
effect to the provisions of this Chapter:

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.

(2) Without prejudice to the generality of the foregoing power, such rules may—

(a) specify the drugs or classes of drugs or cosmetics or classes of cosmetics for the
import of which a licence is required, and prescribe the form and conditions of such
licences, the authority empowered to issue the same, the fees payable therefore and
provide for the cancellation, or suspension of such licence in any case where any
provision of this Chapter or the rules made there under is contravened or any of the
conditions subject to which the licence is issued is not complied with;

(b) prescribe the methods of test of test or analysis to be employed in determining

whether a drug or cosmetic is of standard quality;

(c) prescribe, in respect of biological and organometallic compounds, the units or

methods of standardization;

(cc) prescribe under clause (d) of Section 9A the colour or colours which a drug may bear
or contain for purposes of colouring;

(d) specify the diseases or ailments, which an imported drug may not purport or claim to
prevent, cure or mitigate, and such other effects which such drug may not purport or
claim to have;

(e) prescribe the conditions subject to which small quantities of drugs, the import of
which is otherwise prohibited under this Chapter, may be imported for the purpose of
examination, test or analysis or for personal use;

(f) prescribe the places at which drugs or cosmetics may be imported, and prohibit their
import at any other place;

(g) require the date of manufacture and the date of expiry of potency to be clearly and
truly stated on the label or container of any specified imported drug or class of such drug,
and prohibit the import of the said drug or class of drug after the expiry of a specified
period from the date of manufacture;

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(h) regulate the submission by importers, and the securing, of samples of drugs or
cosmetics for examination, test or analysis by the Central Drugs Laboratory, and
prescribe the fees, if any, payable for such examination, test or analysis;

(i) prescribe the evidence to be supplied, whether by accompanying documents or

otherwise, of the quality of drugs or cosmetics sought to be imported, the procedure of
officers of Customs in dealing with such evidence, and the manner of storage at places of
import of drugs or cosmetics detained pending admission;

(j) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter and the rules made there under of drugs or cosmetics imported
for the purpose only of transport through, and export from India;

(k) prescribe the conditions to be observed in the packing in bottles, packages or other
containers, of imported drugs or cosmetics including the use of packing material which
comes into direct contact with the drugs;

(l) regulate the mode of labeling drugs or cosmetics imported for sale in packages, and
prescribe the matters which shall or shall not be included in such labels;

(m) prescribe the maximum proportion of any poisonous substance which may be added
to or contained in any imported drug, prohibit the import of any drug in which that
proportion is exceeded, and specify substances which shall be deemed to be poisonous
for the purposes of this Chapter and the rules made thereunder;

(n) require that the accepted scientific name of any specified drug shall be displayed in
the prescribed manner on the label or wrapper of any imported, patent or proprietary
medicine containing such drug;

(o) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter or the rules made there under of any specified drug or class of
drugs or cosmetics or class of cosmetics.

13. Offences. – (1) Whoever himself or by any other person on his behalf imports, -

(a) any drug deemed to be adulterated under section 9A or deemed to be a spurious drug
under section 9B or any spurious cosmetic referred to in section 9D or any cosmetic of
the nature referred to in clause (ee) of section 10 shall be punishable with imprisonment
for a term which may extend to three years and a fine which may extend to five thousand
rupees;

(b) any drug or cosmetic other than a drug or cosmetic referred to in clause (a), the
import of which is prohibited under section 10, or any rule made under this Chapter, shall
be punishable with imprisonment for a term which may extend to six months, or with fine
which may extend to five hundred rupees, or with both;

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(c) any drug or cosmetic in contravention of the provisions of any notification issued
under section 10A, shall be punishable with imprisonment for a term which may extend
to three years, or with fine which may extend to five thousand rupees, or with 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
five years, or with fine which may extend to ten thousand rupees, 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 provisions of section 11.

14. Confiscation.— Where any offence punishable under section 13 has been committed,
the consignment of the drugs or cosmetics in respect of which the offence has been
committed shall be liable to confiscation.

15. Jurisdiction. – No Court inferior to that of a Metropolitan Magistrate or of a Judicial

Magistrate of the first class shall try an offence punishable under section 13.

CHAPTER IV
MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS

16. Standards of quality.— (1) For the purposes of this Chapter, the expression
"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 complies 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
purposes of this Chapter, and thereupon the Second Schedule shall be deemed to be
amended accordingly.

17. Misbranded drugs. – For the purposes of this Chapter, a drug shall be deemed to be
misbranded, -

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(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 labeled 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.

17-A. Adulterated drugs. – For the purposes of this Chapter, a drug shall be deemed to
be 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 unsanitary 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.

17-B. Spurious drugs. – For the purposes of this Chapter, a drug shall be deemed to be
spurious, -

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is 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 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.

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17-C. Misbranded cosmetics. – For the purposes of this Chapter, a cosmetic shall be
deemed to be misbranded, -

(a) if it contains a colour which is not prescribed; or

(b) if it is not labeled in the 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.

17-D. Spurious cosmetics. – For the purposes of this Chapter, a cosmetic shall be
deemed to be spurious, --

(a) if it is manufactured under a name which belongs to another cosmetic; or

(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another

cosmetic in a manner likely to deceive or bears upon it or upon its conspicuously marked
so as to reveal its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a 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.

17-E. Adulterated cosmetics. – For the purposes of this Chapter, a cosmetic shall be
deemed to be 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 unsanitary 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.

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18. Prohibition of manufacture and sale or 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, or
distribute –

(i) any drug which is not of a standard quality, or is misbranded, adulterated or spurious;

(ii) any cosmetic which is not of a standard quality or is misbranded or spurious;

(iii) 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 ;

(iv) any drug which by means of any statement design or device accompanying it or by
any other means, purports or claims to prevent, cure or mitigate any such disease or
ailment, or to have any such other effect as may be prescribed;

(v) any cosmetic containing any ingredient, which may render it unsafe or harmful for
use under the directions, indicated or recommended;

(vi) any drug or cosmetic in contravention of any of the provisions of this Chapter or
any rule made there under;

(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 there under;

(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 Chapter.

Provided that nothing in this section shall apply to the manufacture, subject to
prescribed conditions, of small quantities of any drug for the purpose of examination, test
or analysis;

Provided further that 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.

18-A. Disclosure of the name of the manufacturer, etc. – Every person, not being the
manufacturer of a drug or cosmetic or his agent for the distribution thereof, shall, if so

15
required, disclose to the Inspector the name, address and other particulars of the person
from whom he acquired the drug or cosmetic.

18-B. Maintenance of records and furnishing of information.— Every person holding

a licence under clause (c) of section 18 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.

19. Pleas. – (1) Save as hereinafter provided in this section, it shall be no defence in a
prosecution under this Chapter to prove merely that the accused was ignorant of the
nature, substance or quality of the drug or cosmetic in respect of which the offence has
been committed or of the circumstances of its manufacture or import, or that a purchaser,
having bought only for the purpose of test or analysis, has not been prejudiced by the
sale.

(2) For the purposes of section 18 a drug shall not be deemed to be misbranded or
adulterated or spurious or to be below standard quality nor shall a cosmetic be deemed to
be misbranded or to be below standard quality only by reason of the fact that –

(a) there has been added thereto some innocuous substance or ingredient because the
same is required for the manufacture or preparation of the drug or cosmetic as an article
of commerce in a state fit for carriage or consumption, and not to increase the bulk,
weight or measure of the drug or cosmetic or to conceal its inferior quality or other
defects; or

(b) in the process of manufacture, preparation or conveyance some extraneous substance

has unavoidably become intermixed with it; provided that this clause shall not apply in
relation to any sale or distribution of the drug or cosmetic occurring after the vendor or
distributor became aware of such intermixture.

(3) A person, not being the manufacturer of a drug or cosmetic or his agent for the
distribution thereof, shall not be liable for a contravention of section 18 if he proves –

(a) that he acquired the drug or cosmetic from a duly licensed manufacturer, distributor
or dealer thereof;

(b) that he did not know and could not, with reasonable diligence, have ascertained that
the drug or cosmetic in any way contravened the provisions of that section; and

(c) that the drug or cosmetic, while in his possession, was properly stored and remained
in the same state as when he acquired it.

20. Government Analysts. – (1) The State Government may, by notification in the
Official Gazette, appoint such persons as it thinks fit, having the prescribed
qualifications, to be Government Analysts for such areas in the State and in respect of

16
such drugs or classes of drugs or such cosmetics or classes of cosmetics as may be
specified in the notification.

(2) The Central Government may also, by notification in the Official Gazette, 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 sub-section (1) or sub-section (2), 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 sub-section (1) or sub-
section (2) of this section.

21. Inspectors. – (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 qualifications, to be Inspectors for such areas as may be assigned to them by
the 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, 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 a public servant within the meaning of section
21 of the Indian Penal Code, and shall be officially subordinate to such authority having
the prescribed qualifications, as the Government appointing him may specify in this
behalf.

22. Powers of Inspectors. – (1) Subject to the provisions of section 23 and of any rules
made by the Central Government in this behalf, an Inspector may, within the local limits
of the area for which he is appointed, -

(a) inspect, --

(i) any premises wherein any drug or cosmetic is being manufactured and the means
employed for stand arising 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;

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(b) 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) 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 such assistance, if any, as he considers necessary, -

(i) 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 Chapter has been, or is being,
committed; or

(ii) enter and search any place in which he has reason to believe that an offence under
this Chapter has been, or is being, committed; or

(iii) 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 Chapter 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) examine any record, register, document or any other material object found with any
person, or in any 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) 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 Chapter has been, or is being, or is being, committed;

(d) exercise such other powers as may be necessary for carrying out the purposes of this
Chapter or any rules made there under.

(2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974), shall, so far as
may be, apply to any search or seizure under this Chapter as they apply to any search or
seizure made under the authority of a warrant issued under section 94 of the said Code.

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(2A) Every record, register or other document seized under clause (cc) or produced
under clause (cca) 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 therefrom 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 Chapter or refuses to produce any record, register or other
document when so required under clause (cca) of sub-section (1), he shall be punishable
with imprisonment which may extend to three years, or with fine, or with both.

23. Procedure of Inspectors. – (1) Where an Inspector takes any sample of a drug or
cosmetic under this Chapter, he shall tender the fair price thereof and may require a
written acknowledgement therefor.

(2) Where the price tendered under sub-section (1) is refused, or where the Inspector
seizes the stock of any drug or cosmetic under clause (c) of section 22, 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 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;

(ii) the second he shall produce to the Court before which proceedings, if any, are
instituted in respect of the or cosmetic; and

19
(iii) the third, where taken, he shall send to the person, if any, whose name, address and
other particulars have been disclosed under section 18-A.

(5) Where an Inspector takes any action under clause (c) of section 22, -

(a) he shall use all dispatch in ascertaining whether or not the drug or cosmetic
contravenes any of the provisions of 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, taken such action as may be necessary for the return of the stock-
seized;

(b) 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;

(c) 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 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 (cc) of sub-section (1) of section 22, he shall, as soon as may be, inform a
Judicial Magistrate and take his orders as to the custody thereof.

24. 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 any 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.

25. Reports of Government Analysts. – (1) The Government Analyst to whom a sample
of any drug or cosmetic has been submitted for test or analysis under sub-section (4) of
section 23, shall deliver to the Inspector submitting it is 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 under section 18A, 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 of 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 under section 18A 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 contravention of the report.

20
(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 contravention of a Government Analyst’s 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 under sub-section (4)
of Section 23 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 sub-
section (4) shall be paid by the complainant or accused as the Court shall direct.

26. Purchaser of drug or cosmetic enabled to obtain test or analysis. – Any person or
any recognised consumer association, whether such person is a member of that
association or not shall, on application in the prescribed manner and on payment of the
prescribed fee, be entitled to submit for test or analysis to a Government Analyst any
drug or cosmetic purchased by him or it and to receive a report of such test or analysis
signed by the Government Analyst.

Explanation. – For the purposes of this section and section 32, "recognised
consumer association" means a voluntary consumer association registered under the
Companies Act, 1956 or any other law for the time being in force.

26-A. Powers of Central Government to prohibit manufacture, etc., 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.

26-B. Powers of Central Government to regulate or restrict, manufacture, etc., of

drug in public interest. – Without prejudice to any other provision contained in this
Chapter, if the Central Government is satisfied that a drug is essential to meet the
requirements of an emergency arising due to epidemic or natural calamities and that in
the public interest it is necessary or expedient so to do, then, that Government may, by
notification in the Official Gazette, regulate or restrict the manufacture, sale or
distribution of such drug.

27. Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter. –
Whoever, himself or by any other person on his behalf, manufacturers for sale or for
distribution, or sells, or stocks or exhibits or offers for sale or distributes,-

21
(a) any drug deemed to be adulterated under section 17-A or spurious under section 17-B
and 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 (45 of 1860), 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 ten years but which may extend to a
term for life and shall also be liable to fine which shall not be less than ten lakh rupees or
three times value of the drugs confiscated, whicheve is more:

Provided that the fine imposed on and released from, the person convicted under
this clause shall be paid, by way of compensation, to the person who had used the
adulterated or spurious drugs referred to in this clause:

Provided further that where the use of the adulterated or spurious drugs referred to
in this clause has caused the death of a person who used such drugs, the fine imposed on
and realized from, the person convicted under this clause, shall be paid to the relative of
the person who had died due to the use of the adulterated or spurious drugs referred to in
this clause.

Explanation.- For the purposes of the second proviso, the expression “relative”
means-

(i) spouse of the deceased person; or

(ii) a minor legitimate son, and unmarried legitimate daughter and a widowed mother; or

(iii) parent of the minor victim; or

(iv) if wholly dependent on the earnings of the deceased person at the time of his death, a
son or a daughter who has attained the age of eighteen years; or

(v) any person, if wholly or in part, dependent on the earnings of the deceased person at
the time of his death, -

(a) the parent; or

(b) a minor brother or an unmarried sister; or

(c) a widowed daughter-in-law; or

(d) a widowed sister; or

(e) a minor child of a pre-deceased son; or

22
 (f) a minor child of a pre-deceased daughter where no parent of the child is alive;
or

(g) the paternal grandparent if no parent of the member is alive;

(b) any drug —

(i) deemed to be adulterated under section 17A, but not being a drug referred to in clause
(a), or

(ii) without a valid licence as required under clause (c) of section 18, shall be punishable
with imprisonment for a term which shall not be less than three years but which may
extend to five years and with fine which shall not be less than one lakh rupees or three
times the value of the drugs confiscated, whichever is more:

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
and of fine of less than one lakh rupees;

(c) any drug deemed to be spurious under section 17-B, but not being a drug referred to in
clause (a) shall be punishable with imprisonment for a term which shall not be less than
seven years but which may extend to imprisonment for life and with fine which shall not
be less than three lakh rupees or three times the value of the drugs confiscated, whichever
is more:

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 seven years
but not less than three years and fine of less than one lakh rupees;

(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 there under, shall
be punishable with imprisonment for a term which shall not be less than one year but
which may extend to two years and with fine which shall not be less than twenty
thousand 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 one year.

27-A. Penalty for manufacture, sale, etc., of cosmetics in contravention of this

Chapter. – Whoever himself or by any other person on his behalf manufacturers for sale
or for distribution, or sells, or stocks or exhibits or offers for sale –

(i) Any cosmetic deemed to be spurious under section 17-D or adulterated under section
17-E shall be punishable with imprisonment for a term, which may extend to three years
and with fine which shall not be less than fifty thousand rupees or three times the value of
the cosmetics confiscated, whichever is more;

23
(ii) Any cosmetic other than a cosmetic referred to in clause (i) above in contravention
of any provisions of this Chapter or any rule made there under shall be punishable with
imprisonment for a term which may extend to one year or with fine which may extend to
twenty thousand rupees, or with both.

28. Penalty for non-disclosure of the name of the manufacturer, etc.- Whoever
contravenes the provisions of Section 18-A or Section 24 shall be punishable with
imprisonment which may extend to one year, or with fine which shall not be less than
twenty thousand rupees, or with both.

28-A. Penalty for not keeping documents etc., and for non-disclosure of
information.- Whoever contravenes the provisions of Section 18-B shall be punishable
with imprisonment which may extend to one year, or with fine which shall not be less
than twenty thousand rupees, or with both.

28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section

26A. – Whoever himself or by any other person on his behalf manufacturers or sells or
distributes any drug or cosmetic in contravention of the provisions of any notification
issued under section 26A, shall be punishable with imprisonment for a term which may
extend to three years and shall also be liable to fine which may extend to five thousand
rupees.

29. Penalty for use of Government Analyst’s 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.

30. Penalty for subsequent offences. – (1) Whoever having been convicted of an
offence, -

(a) under clause (b) of section 27 is again convicted of an offence under that clause,
shall be punishable with imprisonment for a term which shall not be less than seven years
but which may extend to ten years and with fine which shall not be less than two lakh
rupees:

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
seven years and of fine of less than one lakh rupees:

(b) under clause (c) of section 27, is again convicted of an offence under that clause
shall be punishable with imprisonment for a term which shall not be less than ten years
but which may extend to imprisonment for life and with fine which shall not be less than
three lakh rupees;

(c) under clause (d) of section 27, is again convicted of an offence under that clause
shall be punishable with imprisonment for a term which shall not be less than two years

24
but which may extend to four years or with fine which shall not be less than five
thousand rupees, or with both.

(1-A) Whoever, having been convicted of an offence under section 27-A is again
convicted under that section, shall be punishable with imprisonment for a term which
may extend to two years, or with fine which may extend to two thousand rupees, or with
both.

(2) Whoever, having been convicted of an offence under section 29 is again convicted of
an offence under the same section, shall be punishable with imprisonment which may
extend to two years, or with fine which shall not be less than ten thousand rupees or with
both.

31. Confiscation. – (1) Where any person has been convicted under this Chapter for
contravening any such provision of this Chapter or any rule made there under 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 and if such contravention is in
respect of –

(i) manufacture of any drug deemed to be misbranded under section 17, adulterated
under section 17-A or spurious under section 17-B ; 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 under clause (c) of
section 18,

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 or is a 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.

31A. Application of provisions to Government departments. – The provisions of this

Chapter except those contained in section 31 shall apply in relation to the manufacture,
sale or distribution of drugs by any department of Government as they apply in relation to
the manufacture, sale or distribution of drugs by any other person.

32. Cognizance of offences. – (1) No prosecution under this Chapter shall be instituted
except by-

(a) an Inspector, or

25
(b) any Gazetted Officer of the Central Government or a State Government authorized in
writing in this behalf by the Central Government or a State Government by ageneral or
special order made in this behal by that Government; or

(c) the person aggrieved; or

(d) a recognised consumer association whether such person is a member of that

association or not.

(2) Save as otherwise provided in this Act, no court inferior to that of a Court of
Sessions shall try an offence punishable under this Chapter.

(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.

32-A. Power of Court to implead the manufacturer, etc. – Where, at any time during
the trial of any offence under this Chapter alleged to have been committed by any person,
not being the manufacturer of a drug or cosmetic or his agent for the distribution thereof,
the Court is satisfied, on the evidence adduced before it, that such manufacturer or agent
is also concerned in that offence, then, the Court may, notwithstanding contained in sub-
sections (1), (2) and (3) of section 319 of the Code of Criminal Procedure, 1973 (2 of
1974), proceed against him as though a prosecution had been instituted against him under
section 32.

32-B. Compounding of certain offences.- (1) Notwithstanding anything contained in

the Code of Criminal Procedure, 1973 (2 of 1974), any offence punishable under clause
(b) of sub-section (1) of Section 13, Section 28 and Section 28-A of this Act(whether
committed by a company or any officer thereof), not being an offence punishable with
imprisonment only, or with imprisonment and also with fine, may, either before or after
the instructions of any prosecution, be compounded by the Central Government or by
any State Government or any officer authorized in this behalf Central Government or a
State Government, on payment for credit to that Government of such sum as that
Government may, by rules made in this behalf, specify:

Provided that such sum shall not, in any case, exceed the maximum amount of the
fine which may be imposed under this Act for the offences so compounded:

Provided further that in cases of subsequent offences, the same shall not be
compoundable.

(2) When the accused has been committed for trial or when he has been convicted and an
appeal is pending, no composition for the offences shall be allowed without the leave of
the court to which he is committed or, as the case may be, before which the appeal is to
be heard.

26
(3) Where an offence is compounded under sub-section (1), no proccding or further
proceeding, as the case may be , shall be taken against the offender in respect of the
offences so compounded and the offender, if in custody, shall be released forthwith.

33. Power of Central Government to make rules. – (1) 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 Chapter :

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.

(2) Without prejudice to the generality of the foregoing power, such rules may –

(a) provide for the establishment of laboratories for testing and analyzing drugs or
cosmetics;

(b) prescribe the qualifications and duties of Government Analysts and the qualifications
of Inspectors;

(c) prescribe the methods of test or analysis to be employed in determining whether a

drug or cosmetic is of standard quality;

(d) prescribe, in respect of biological and organ metallic compounds, the units or methods
of standardization;

(dd) prescribe under clause (d) of section 17-A the colour or colours which a drug may
bear or contain for purposes of colouring;

(dda) prescribe under clause (d) of section 17-E the colour or colours which a cosmetic
may bear or contain for purposes of colouring;

(e) prescribe the forms of licences for the manufacture for sale or for distribution, for the
sale and for the distribution of drugs or any specified drug or class of drugs or of
cosmetic or any specified cosmetic or class of cosmetics, the form of application for such
licences, the conditions subject to which such licences may be issued, the authority
empowered to issue the same the qualifications of such authority and the fees payable
therefore and provide for the cancellation or suspension of such licences in any case
where any provision of this Chapter or the rules made there under is contravened or any
of the conditions subject to which they are issued is not complied with;

27
(ee) prescribe the records, registers or other documents to be kept and maintained under
section 18-B;

(eea) prescribed the fees for the inspection (for the purposes of grant or renewal of
licences) of premises, wherein any drug or cosmetic is being or is proposed to be
manufactured;

(eeb) prescribe the manner in which copies are to be certified under sub-section (2-A) of
section 22;

(f) specify the diseases or ailments, which a drug may not purport or claim to prevent,
cure or mitigate and such other effects which a drug may not purport or claim to have;

(g) prescribe the conditions subject to which small quantities of drugs may be
manufactured for the purpose of examination, test or analysis;

(h) require the date of manufacture and the date of expiry of potency to be clearly and
truly stated on the label or container of any specified drug or class of drugs, and prohibit
the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs
after the expiry of a specified period from the date of manufacture or after the expiry of
the date of potency;

(i) prescribe the conditions to be observed in the packing in bottles, packages, and other
containers of drugs or cosmetics including the use of packing material which comes into
direct contact with the drugs and prohibit the sale, stocking or exhibition for sale, or
distribution of drugs or cosmetics packed in contravention of such conditions;

(j) regulate the mode of labeling packed drugs or cosmetics, and prescribe the matters,
which shall or shall not be included in such labels;

(k) prescribe the maximum proportion of any poisonous substance which may be added
to or contained in any drug, prohibit the manufacture, sale or stocking or exhibition for
sale, or distribution of any drug in which that proportion is exceeded, and specify
substances which shall be deemed to be poisonous for the purposes of this Chapter and
the rules made there under;

(l) require that the accepted scientific name of any specified drug shall be displayed in
the prescribed manner on the label or wrapper of any patent or proprietary medicine
containing such drug;

(m) omitted.

(n) prescribe the powers and duties of and the qualifications of the authority to which
such Inspectors shall be subordinate and specify 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;

28
(o) prescribe the forms of report to be given by Government Analysts, and the manner
of application for test or analysis under section 26 and the fees payable therefore;

(p) specify the offences against this Chapter or any rule made there under in relation to
which an order of confiscation may be made under section 31;

(q) provide for the exemption, conditionally or otherwise, from all or any of the
provisions of this Chapter or the rules made there under, of any specified drug or class of
drugs or cosmetic or class of cosmetics; and

(r) sum which may be specified by the Central Government under section 32-B.

33-A. Chapter not to apply to Ayurvedic, Siddha or Unani drugs. – Save as otherwise
provided in this Act, nothing contained in this Chapter shall apply to Ayurvedic, Siddha
or Unani drugs.

CHAPTER IV-A
PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS

33-B. Application of Chapter IVA. – This Chapter shall apply only to Ayurvedic,
Siddha and Unani drugs.

33-C. Ayurvedic and Unani Drugs Technical Advisory Board. – (1) The Central
Government shall, by notification in the Official Gazette and with effect from such date
as may be specified therein, 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 arising out of this Chapter and to carry out the other
functions assigned to it by this Chapter.

(2) The Board shall consist of the following members, namely, -

(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;

(v) One person holding the appointment of Government Analyst under section 33-F, 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;

29
(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 Unani Pharmacopoeia Committee and one from amongst the members of the Siddha
Pharmacopoeia Committee;

(ix) One teacher in Darvyaguna, and Bhaishajya Kalpana, to be nominated by the Central
Government;

(x) One teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWASAZI, 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 amongst the practitioners of Ayurvedic, Siddha and
Unani Tibb systems 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 recombination.

(5) The Board may, subject to the previous approval of the Central Government, make
bye-laws fixing 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.

33-D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee. – (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.

30
(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.

33-E. Misbranded drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be 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 labeled 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.

33-EE. Adulterated drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be adulterated, -

(a) If it consists, in whole or in part, of any filthy, putrid or decomposed substance; or

(b) It has been prepared, packed or stored under in sanitary 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.

Explanation. – For the purpose of clause (a), a drug shall not be deemed to
consist, in whole or in part, of any decomposed substance only by reason of the fact that
such decomposed substance is the result of any natural decomposition of the drug:

Provided that such decomposition is not due to any negligence on the part of the
manufacturer of the drug or the dealer thereof and that it does not render the drug
injurious to health.

33-EEA. Spurious drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or
Unani drug shall be deemed to be spurious –

31
(a) If it is sold, or offered or exhibited for sale, under a name which belongs to another
drug; or

(b) If it is an imitation of, or is 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 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 any other drug or substance; or

(e) If it purports to be the product of a manufacturer of whom it is not truly a product.

33-EEB. Regulation of manufacturer 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.

33-EEC. Prohibition of manufacture and sale of certain Ahyurvedic, Siddha and

Unani drugs. – 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 Ayurvedic, siddha or Unani drug;

(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 of
this Chapter or any rule made thereunder;

(b) Sell, stock or exhibit or offer for sale or offer for sale or distribute any Ayurvedic,
Siddha or Unani drug which has been manufactured in contravention of any of the
provisions of this Act, or any rule made thereunder:

(c) Manufacture for sale or for distribution, any Ahyurvedic, Siddha or Unani drug,
except under, and in accordance with the conditions of, a licence issued for such purpose
under this Chapter by the prescribed authority.

32
 Provided that nothing in this section shall 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.

33-EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic,

Siddha or Unani drugs in public interest. – Without prejudice to any other provision
contained in this Chapter, if the Central Government is satisfied on the basis of any
evidence or other material available before it that the use of any Ahyurvedic, 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.

33-F. Government Analysts. – (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 qualifications 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 sub-section (1), 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.

33-G. Inspectors. – (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 qualifications, to be Inspectors for such areas as may be assigned to them by
the 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 the meaning of section
21 of the Indian Penal Code and shall be officially sub-ordinate to such authority as the
Central Government appointing him may specify in this behalf.

33
33-H. Application of provisions of sections 22, 23, 24 and 25. – The provisions of
sections 22, 23, 24 and 25 and the rules, if any, made there under shall, so far as may be,
apply in relation to an Inspector and a Government Analyst appointed under this Chapter
as they apply in relation to an Inspector and a Government Analyst appointed under
Chapter IV, subject to the modification that the references to "drug" in the said sections,
shall be construed as references to Ayurvedic, Siddha or Unani drug.

33-I. Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in
contravention of this Chapter. – Whoever himself or by any other person on his
behalf—

(1) Manufactures for sale or for distribution –

(a) Any Ayurvedic, Siddha or Unani drug –

(i) Deemed to be adulterated under section 33EE, or

(ii) Without a valid licence as required under clause ( c) of section 33EEC,

shall be punishable with imprisonment for a term which may extend to one year and with
fine which shall not be less than twenty thousand rupees or three times the value of the
drugs confiscated, whichever is more;

(b) Any Ayurvedic, Siddha or Unani drug deemed to be spurious under section 33EEA,
shall be punishable with imprisonment for a term which shall not be less than one year
but which may extend to three years and with fine which shall not be less than fifty
thousand rupees or three times the value of the drugs confiscated, whichever is more:

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
one year and of fine of less than fifty thousand rupees or three times the value of the
drugs confiscated, whichever is more; or

(c) any Ayurvedic, Siddha or Unani drug in contravention of the provisions of

any notifications issuedunder Section 33-EED shall be punishable with imprisonment for
a term which may extend to three years and with fine which may extend to fifty thousand
rupees or three times the value of the drugs confiscated, whichever is more.

(2) Contravenes any other provisions of this Chapter or of section 24 as applied by

section 33H or any rule made under this Chapter, shall be punishable with imprisonment
for a term which may extend to six months and with fine which shall not be less than ten
thousand rupees.

33-J. Penalty for subsequent offences. – Whoever having been convicted of an

offences, -

34
 (a) Under clause (a) of sub-section (1) of section 33-I is again convicted of an
offence under that clause, shall be punishable with imprisonment for a term which may
extend to two years and with fine which shall not be less than fifty thousand rupees or
three times the value of the drugs confiscated, whichever is more;

(b) Under clause (b) of sub-section (1) of section 33-I is again convicted of an
offence under that clause, shall be punishable with imprisonment for a term which shall
not be less than two years but which may extend to six years and with fine which shall
not be less than one lakh rupees or three times the value of the drugs confiscated,
whichever is more::

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
two years and of fine of less than one lakh rupees or three times the value of the drugs
confiscated, whichever is more; ;

(c) Under sub-section (2) of section 33-I is again convicted of an offence under
that sub-section, shall be punishable with imprisonment for a term which may extend to
one year and with fine which shall not be less than twenty thousand rupees or three times
the value of the drugs confiscated, whichever is more; .

33-K. Confiscation. – Where any person has been convicted under this Chapter, the
stock of the Ayurvedic, Siddha or Unani drug, in respect of which the contravention has
been made, shall be liable to confiscation.

33-KA. Disclosure of name of manufacturer etc., –Every person, not being the
manufacturer of any Ayurvedic, Siddha or Unani drug 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 Ayurvedic, Siddha or Unani drug.

33-KB. Maintenance of records and furnishing of information.— Every person

holding a licence under clause (c) of section 33-EEC 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.

33-L. Application of provisions to Government departments. – The provisions of this

Chapter except those contained in section 33K shall apply in relation to the manufacture
for sale, sale or distribution of any Ayurvedic, Siddha or Unani drug by any department
of Government as they apply in relation to the manufacture for sale, sale or distribution of
such drug by any other person.

33-M. Cognizance of offences. – (1) No prosecution under this Chapter shall be

instituted except by an Inspector with the previous sanction of the authority specified
under sub-section (4) of section 33-G.

35
(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 this Chapter.

33-N. Power of Central Government to make rules. – (1) 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 Chapter :

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 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.

(2) Without prejudice to the generality of the foregoing power, such rules may –

(a) Provide for the establishment of laboratories for testing and analysing Ayurvedic,
Siddha or Unani drugs;

(b) Prescribe the qualifications and duties of Government Analysts and the qualifications
of Inspectors;

(c) Prescribe the methods of test or analysis to be employed in determining whether any
Ayurvedic, Siddha or Unani drug is labeled with the true list of the ingredients which it is
purported to contain;

(d) Specify any substance as a poisonous substance;

(e) Prescribe the forms of licences for the manufacture for sale of Ayurvedic, Siddha or
Unani drug and for sale of processed Ayurvedic, Siddha or Unani drugs, the form of
application for such licences, the conditions subject to which such licences may be
issued, the authority empowered to issue the same and the fees payable therefore, and
provide for the cancellation or suspension of such licences in any case where any
provision of this Chapter or rules made there under is contravened or any of the
conditions subject to which they are issued is not complied with;

(f) Prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and
Unani drugs including the use of packing material which comes into direct contact with
the drugs, regulate the mode of labeling packed drugs and prescribe the matters which
shall or shall not be included in such labels;

(g) Prescribe the conditions subject to which small quantities of Ayurvedic, Siddha or
Unani] drugs may be manufactured for the purpose of examination, test or analysis;

36
(gg) Prescribe under clause (d) of section 33-EE the colour or colours which an
Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;

(gga) Prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33-EB;

(h) Any other matter which is to be or may be prescribed under this Chapter.

33-O. 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.

CHAPTER V
MISCELLANEOUS

33-P. 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 there under.

34. 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 the 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.

Explanation. – 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.

37
34-A. Offences by Government Departments. – Where an offence under Chapter IV or
Chapter IVA 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 Chapter IV or Chapter IVA, 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.

34-AA. Penalty for vexatious search or seizure. — Any Inspector exercising powers
under this Act or the rules made there under, 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.

35. 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 offender’s 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 costs relating
to the conviction and shall be recoverable in the same manner as those costs are
recoverable.

36. Magistrate’s power to impose enhanced penalties. – Notwithstanding anything

contained in the Code of Criminal Procedure, 1973 (2 of 1974), it shall be lawful for any
Metropolitan Magistrate or any Judicial Magistrate of the first class to pass any sentence
authorized by this Act excess of his powers the said Code.

38
36-A. Certain offences to be tried summarily. – Notwithstanding anything contained
in the Code of Criminal Procedure, 1973 (2 of 1974), all offences except the offences
triable by the Special Court under Section 36-AB or Court of Sessions 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 33-I, 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 sections 262 to 265
(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.

36-AB. Special Courts. –The Central Government, or the State Government, in

consultation with the Chief Justice of the High Court, shall, for trial of offences relating
to adulterated drugs or spurious drugs punishable under clause (a) and (b) of Section 13,
sub-section (3) of Section 22, clause (a) and (c) of Section 27, Section 28, Section 28-A,
Section 28-B and clause (b) of sub-section (1) of Section 30 and other offences relating to
adulterated drugs or spurious drugs, by notification, designate one or more Courts of
Sessions as a Special Court or Special Courts for such area or for such case or class or
group of cases as may be specified in the notification.

Explanation.- In this sub-section, “High Court”means the High Court of the State
in which a Court of Sessions designated as Special Court was functioning immediately
before such designation.

(2) While trying an offence under this Act, a Special Court shall also try an offence, other
than an offence referred to in sub-section (1), with which the accused may, under the
Code of Criminal Procedure, 1973 (2 of 1974), be charged at the same trial.

36-AC. Offences to be cognizable and non-bailable in certain cases. – (1)

Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of
1974)-

(a) every offence, relating to adulterated or spurious drug and punishable under clause (a)
and (c) of sub-section (1) Section 13, clause (a) of sub-section (2) of Section 13, sub-
section (3) of Section 22, clause (a) and (c) of Section 27, Section 28, Section 28-A,

39
Section 28-B and sub-section (1) and (2) of Section 30 and other offences relating to
adulterated drugs or spurious drugs, shall be cognizable.

(b) no person accused, of an offence punishable under clause (a) and (c) of sub-section
(1) of Section 13, clause (a) of sub-section (2) of Section 13, sub-section (3) of Section
22, clause (a) and (c) of Section 27, Section 28, Section 28-A, Section 28-B and sub-
section (1) and (2) of Section 30 and other offences relating to adulterated drugs or
spurious drugs, shall be released on bail or on his own bond unless-

(i) the Public Prosecutor has been given an opportunity to oppose the application for such
release; and

(ii) where the Public Prosecutor opposes the application, the court is satisfied that there
are reasonable grounds for believing that he is not guilty of such offence and that he is
not likely to commit any offence while on bail:

Provided that a person, who, is under the age of sixteen years,or is a woman or is
sick or infirm, may be released on bail, if the Special Court so directs.

(2) The limitation on granting of bail specified in clause (b) of sub-section (1) is in
addition to the limitations under the Code of Criminal Procedure, 1973 (2 of 1974) or any
other law for the time being in force on granting bail.

(3) Nothing contained in this section shall be deemed to affect the Special powers of the
High Court regarding bail under Section 439 of the Code of Criminal Procedure, 1973 (2
of 1974) and the High Court may exercise such powers including the power under clause
(b) of sub-section (1) of that section as if the reference to “Magistrate” in that section
includes also a reference to “Special Court” designated under Section 36-AB.

36-AD. Application Code of Criminal Procedure, 1973 to proceedings before

Special Courts. – (1) Save as otherwise provided in this Act, the provisions of the Code
of Criminal Procedure, 1973 (2 of 1974) (including the provisions as to bails and bonds),
shall apply to the proceedings before a Special Courts and for the purpose of said
provisions, the Special Court shall be deemed to be a Court of Sessions and the person
conducting the prosecution before the Special Court, shall be deemed to be a Public
Prosecutor:

Provided that the Central Government or the State Government may also appoint,
for any case or cases or group of cases, a Special Public Prosecutor.

(2) A person shall not be qualified to be appointed as Public Prosecutor or a Special

Public Prosecutor under this section unless he has been in practice as an advocate for not
less than seven years, under the Union or a State, requiring special knowledge of law.

(3) Every person appointed as a Public Prosecutor or a Special Public Prosecutor under
this section shall be deemed to be a Public Prosecutor within the meaning of clause (u) of

40
Section 2 of the Code of Criminal Procedure, 1973 (2 of 1974) and the provisions of that
Code shall have effect accordingly.

37. 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.

38. Rules to be laid before Parliament. – Every rule made 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 form 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.

THE FIRST SCHEDULE

[See section 3(a)]

A.—AYURVEDIC AND SIDDHA SYSTEMS

Serial
Name of Book
No.
AYURVEDA
1. Arogya Kalpadruma
2. Arka Prakasha
3. Arya Bhishak
4. Ashtanga Hridaya
5. Ashtanga Samgraha
6. Ayurveda Kalpadruma
7. Ayurveda Prakasha
8. Ayurveda Samgraha
9. Bhaishajya Ratnavali
10. Bharat Bhaishajya Ratnakara
11. Bhava Prakasha
12. Brihat Nighantu Ratnakara
13. Charaka Samhita

41
14. Chakra Datta
15. Gada Nigraha
16. Kupi Pakva Rasayana
17. Nighantu Ratnakara
18. Rasa Chandanshu
19. Rasa Raja Sundara
20. Rasaratna Samuchaya
21. Rasatantra Sara Siddha Prayoga Samgraha – Part I
22. Rasa Tarangini
23. Rasa Yoga Sagra
24. Rasa Yoga Ratnakara
25. Rasa Yoga Samgraha
26. Rasendra Sara Samgraha
27. Rasa Pradipika
28. Sahasrayoga
29. Sarvaroga Chikitsa Ratnam
30. Sarvayoga Chikitsa Ratnam
31. Siddha Bhaishajya Manimala
32. Sharangadhara Samhita
33. Siddha Yoga Samgraha
34. Sushruta Samhita
35. Vaidya Chintamani
36. Vaidyaka Shabda Sindu
37. Vaidyaka Chikitsa Sara
38. Vaidya Jiwan
39. Basava Rajeeyam
40. Yoga Ratnakara
41. Yoga Tarangini
42. Yoga Chintamani
43. Kashyapasamhita
44. Bhelasamhita
45. Vishwanathachikitsa
46. Vrindachikitsa
47. Ayurvedachintamani
48. Abhinavachintamani
49. Ayurveda-ratnakar

42
 50. Yogaratnasangraha
51. Rasamrita
52. Dravyagunanighantu
53. Rasamanjari
54. Bangasena
54-A. Aurvedic Formulary of India
54-B. Aurveda Sara Sangraha.
54-C. Ayurvedic Pharmacopoeia of India
SIDDHA
55. Siddha Vaidya Thirattu
56. Therayar Maha Karisal
57. Brahma Muni Karukkadi (300)
58. Bhogar (700)
59. Pulippani (500)
60. Agasthiya Paripuranam (400)
61. Therayar Yamagam
62. Agasthiya Chenduram (300)
63. Agasthiyar (1500)
64. Athmarakshamrutham
65. Agasthiyar Pin (80)
66. Agasthiyar Rathna Churukkam
67. Therayar Karisal (300)
68. Veeramamuni Nasa Kandam
69. Agasthiyar (600)
70. Agasthiyar Kanma Soothiram
71. 18 Siddhar’s Chillarai Kovai
72. Yogi Vatha Kaviyam
73. Therayar Tharu
74. Agasthiyar Vaidya Kaviyam (1500)
75. Bala Vagadam
76. Chimittu Rathna (Rathna) Churukkam
77. Nagamuni (200)
78. Agasthiyar Chillarai Kovai
79. Chiktsa Rathna Deepam
80. Agasthiyar Nayana Vidhi
81. Yugi Karisal (151)

43
 82. Agasthiya Vallathi (600)
83. Therayar Thaila Varkam
84. Siddha Formulary of India (Part-I)
B. – UNANI TIBB SYSTEM
1. Karabadin Qadri
2. Karabadin Kabir
3. Karabadin Azam
4. Iiaj-ul-amraz
5. Al Karabadin
6. Biaz Kabir Vol.II
7. Karabadin Jadid
8. Kitab-ul-Taklis
9. Sanat-ul-Taklis
10. Mifta-ul-Khazain
11. Madan-ul-Aksir
12. Makhzan-ul-Murabhat
13. National Formulary of Unani Medicine
14. Unani Pharmacopoeia of India

THE SECOND SCHEDULE

[See sections 8 and 16]

STANDARDS TO BE COMPLIED WITH BY IMPORTED DRUGS AND BY DRUGS

MANUFACTURED FOR SALE, STOCKED OR EXHIBITED FOR SALE OR DISTRIBUTED

S. No. Class of Drug Standard to be complied with

1. Patent or proprietary other than The formula or list of ingredients displayed
Homoeopathic medicines. in the prescribed manner on the label or
container and such other standards as may
be prescribed.
2. Substances commonly known as The standards maintained at the International
vaccines, sera, toxins, toxoids, Laboratory for Biological Standards, Stantans
antitoxins, and antigens and Serum Institute, Copenhagen, and at the Central
biological products of such nature Veterinary Laboratory, Weybridge, Surrey,
for human or veterinary use. U.K., and such other laboratories recognized by
W.H.O from time to time, and such further
standards of strength, quality and purity as may
be prescribed.

44
 3. Omitted. Omitted.
4. Substances (other than food) Such standards as may be prescribed.
intended to affect the structure or
any function of the human body or
intended to be used for the
destruction of vermin or insects
which cause disease in human
beings or animals.
4-A. Homoeopathic Medicines:
(a) Drugs included in the Standards of identity, purity and strength
Homoeopathic Pharmacopoeia of specified in the edition of the Homoeopathic
India. Pharmacopoeia of India for the time being
and such other standards as may be
prescribed.
(b) Drugs not included in the Standards of identity, purity and strength
Homoeopathic Pharmacopoeia of prescribed for the drugs in the edition of
India but which are included in the such Pharmacopoeia for the time being in
Homoeopathic Pharmacopoeia of which they are given and such other
United States of America or the standards as may be prescribed.
United Kingdom or the German
Homoeopathic Pharmacopoeia.
(c) Drugs not included in the The formula or list of ingredients displayed
Homoeopathic Pharmacopoeia of in the prescribed manner on the lable of the
India or the United States of container and such other standards as may
America, or the United Kingdom or be prescribed by the Central Government.
the German Homoeopathic
Pharmacopoeia.
5. Other drugs:
(a) Drugs included in the Indian
Standards of identity, purity and strength
Pharmacopoeia.
specified in the edition of the Indian
Pharmacopoeia for the time being 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.

45
(b) Drugs not included in the Standards of identity, purity and strength
Indian Pharmacopoeia but which are specified for drugs in the edition of such
included in the official official Pharmacopoeia of any other country
Pharmacopoeia of any other for the time being in force and such other
country. standards as may be prescribed.

In case the standards of identity, purity and

strength for drugs are not specified in the
edition of such official Pharmacopoeia for
the time being in force but are specified in
the edition immediately strength shall be
those occurring in such immediately
preceding edition of such official
Pharmacopoeia and such other standards as
may be prescribed.

46