LexThe drugs and cosmetics act, 1940
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THE DRUGS AND COSMETICS ACT, 1940
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ARRANGEMENT OF SECTIONS
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CHAPTER I
INTRODUCTORY
SECTIONS
1. Short title, extent and commencement.
2. Application of other laws not barred.
3. Definitions.
3A. Construction of references to any law not in force or any functionary not in
existence in the State of Jammu and Kashmir.
4. Presumption as to poisonous substances.
CHAPTER II
THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE
DRUGS CONSULTATIVE COMMITTEE
5. The Drugs Technical Advisory Board.
6. The Central Drugs Laboratory.
7. The Drugs Consultative Committee.
7 A .Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.
CHAPTER III
IMPORT OF DRUGS AND COSMETICS
8. Standards of quality.
9. Misbranded drugs.
9A. A dulterated drugs.
9B. Spurious drugs.
9C. Misbranded cosmetics.
9D. Spurious cosmetics.
10. Prohibition of import of certain drugs or cosmetics.
10A. Power of Central Government to prohibit import of drugs and cosmetics in
public interest.
11. Application of law relating to sea customs and powers of Customs officers.
12. Power of Central Government to make rules.
13. Offences.
14. Confiscation.
15. Jurisdiction.
2
CHAPTER IV
MANUFACTURE. SALE AND DISTRIBUTSION OF DRUGS AND COSMETICS
SECTIONS
16. Standards of quality.
17. Misbranded drugs.
17A. Adulterated drugs.
17B. Spurious drugs.
17C. Misbranded cosmetics.
17D. Spurious cosmetics.
17E. Adulterated cosmetics.
18. Prohibition of manufacture and sale of certain drugs and cosmetics.
18A. Disclosure of the name of the manufacturer, etc.
18B. Maintenance of records and furnishing of information.
19. Pleas.
20. Government Analysts.
21. Inspectors.
22. Powers of Inspectors.
23. Procedure of Inspectors.
24. Persons bound to disclose place where drugs or cosmetics ar e manufactured or kept.
25. Reports of Government Analysts.
26. Purchaser of drug or cosmetic enabled to obtain test or analysis.
26A. Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of
drug and cosmetic in public interest.
26B. Powers of Central Government to regulate or restrict, manufacture, etc., of drug in
public interest.
27. Penalty for manufacture, sale , etc., of drugs in contravention of this Chap ter.
27A. Penalty for manufacture, sale , etc., of cosmetics in contravention of this Chapter.
28. Penalty for non -disclosure of the name of the manufacturer , etc.
28A. Penalty for not keeping documents , etc., and for non -disclosure of information.
28B. Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A.
29. Penalty for use of Government Analyst ’s report for advertising.
30. Penalty for subsequent offences.
31. Confiscation.
31A. Application of provisions to Government departments.
32. Cognizance of offences.
32A. Power of Court to implead the manufacturer, etc.
32B. Compounding of certain offences.
33. Power of Central Government to make rules.
33A . Chapter not to apply to Ayurvedic, Siddha or Unani drugs.
CHAPTER IVA
PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS
33B. Application of Chapter IVA.
33C. Ayurvedic and Unani Drugs Technical Advisory Board.
33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee.
3
SECTIONS
33E. Misbranded drugs.
33EE. Adulterated drugs.
33EEA.Spurious drugs.
33EEB. Regulation of manufacture for sale of Ayurvedic, Siddha and Unani
drugs.
33EEC. Prohibition of manu facture and sale of certain Ayurvedic, Siddha and Unani
drugs.
33EED. Power of Central Government to prohibit man ufacture, etc., of Ayurvedic,
Siddha or Unani drugs in public interest.
33F. Government Analysts.
33G. Inspectors.
33H. Application of provisions of sections 22, 23, 24 and 25.
33-I. Penalty for manufacture, sale, etc., of Ayurvedic. Siddha or Unani drug in
contravention of this Chapter.
33J. Penalty for subsequent offences.
33K. Confiscation.
33KA. Disclosure of name of manufacturer, etc.
33KB. Maintenance of records and furnishing of informantion.
33L. Application of provisions to Government departments.
33M. Cognizance of offences.
33N. Power of Central Government to make rules.
33-O. Power to amend First Schedule.
CHAPTER V
MISCELLANEOUS
33P. Power to give directions.
34. Offences by companies.
34A. Offences by Government departments.
34AA. Penalty for vexatious search or seizure.
35. Publication of sentences passed under this Act.
36. Magistrate’s power to impose enhanced penalties.
36A. Certain offences to be tried summarily.
36AB. Special Courts.
36AC. Offences to be cognizable and non-bailable in certain cases.
36AD. Application of Code of Criminal Procedure, 1973 to proceedings before special Court.
36AE. Appeal and revision.
37. Protection of action taken in good faith.
38. Rules to be laid before Parliament.
THE FIRST SCHEDULE.
THE SECOND SCHEDULE.
4
THE DRUGS AND COSMETICS ACT, 1940
ACT NO. 23 OF 19401
[10th April, 1940.]
An Act to regulate the import, manufacture, distribution and sale of drugs 2[and cosmetics].
WHEREAS it is expedient to regulate the 3[import, manufacture, distribution and sale] of drugs 2[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 and 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 4[and Cosmetics]
Act, 1940.
(2) It extends to the whole of India 5* * *.
(3) It shall come into force at once; but Chapter III shall take effect only from such date6 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 6 as the State Government may,
by like notification, appoint in this behalf :
7[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only
from such date 8 after the commencement of the Drugs and Cosmetics (Amendment) Act , 1972
(19 of 1972), as the C entral Government may, by notification in the Official Gazette, appoint in this
behalf.]
1. The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government notification
No. 3358-LSG., dated the 25th August, 1941.
2. Ins. by Act 21 of 1962, s.2 (w.e.f. 27-7-1964).
3. Subs. by the A.O. 1950, for certain words.
4. Ins. by Act 21 of 1962, s. 3 (w.e.f. 27-7-1964).
5. The words “except the State of Jammu and Kashmir” omitted by Act 19 of 1972, s. 2.
6. 1st April, 1947; see notification No. F. 28(10) (3) 45H(I), dated the 2nd September, 1946, Gazette of India, 1946, Pt. I, p. 1349.
Ch. IV came into force in the State s of Delhi. Ajmer and Coorg on the 1 st April, 1947, see ibid., Chs. III and IV came into
force in the States of H.P. , Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on the 1 st April, 1953, vide
notification No. S.R.O. 663, dated the 30th March, 1953, Gazette of India, Pt II, Sec. 3, p. 451.
Ch. IV came into force in the Union territory of Dadra and Nagar Haveli w.e.f. 1 st August, 1968,
see notification. No. ADM/Law/117(74), dated the 20th July, 1968, Gazette of India, PT. III, Sec. 3, p. 128.
The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, s. 2 and Sch. I; to Pondicherry by Reg. 7 of 1963, s. 3
and the Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and to the whole of the Union territory of Lakshadweep by
Reg. 8 of 1965, s. 3 and Sch.
7. Added by Act 19 of 1972, s. 2.
8. 24th August, 1974, vide notification. No. S.O. 2185, dated the 9th August, 1974, Gazette of India, 1974, Pt. II, Sec. 3 (ii), p. 2331.
5
2. A pplication 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 (2 of 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, —
1[(a) “2[Ayurvedic, Siddha or Unani] drug ” includes all medicines intended for
internal or external use for or in the diagnosis, treatment, mitigation or prevention of
3[disease or disorder in human beings or animals, and manufactured] exclusively in
accordance with the formulae described in, the authoritative books of 3[Ayurvedic,
Siddha and Unani Tibb system of medicine], specified in the First Schedule;]
4[( aa ) “the Board ” means —
(i) in relation to 2[Ayurvedic, Siddha or Unani] drug , the 3[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;]
5[ 6[(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 ar ticle intended for use as a component of cosmetic 7* * *;]
8[(b) “drug ” includes —
9[(i) all medicines for internal or external use of human beings or animals and all
substances intended to be used for or in the diagnosis, treatment, mitigation or
preven tion 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 10[vermin]
or insects which cause disease in human beings or animals, as may be specified
from time to time by the Central Government by notification in the Official
Gazette;]
11[(iii ) all substances in tended 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 ;]
1. Ins. by Act 13 of 1964, s. 2 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
3. Subs. by s. 3, ibid., for certain words (w.e.f. 1-2-1983).
4. Clause (a) was re -lettered as cl. ( aa) and subs. by Act 13 of 1964, s. 2 (w.e.f. 15 -9-1964).
5. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27 -7-1964).
6. Clause (aa) re-lettered by Act 13 of 1964, s. 2 (w.e.f. 15 -9-1964).
7. Certain words omitted by Act 68 of 1982, s.3 (w.e.f. 1-2-1983).
8. Subs. by Act 11 of 1955, s. 2, for cl. (b).
9. Subs. by Act 68 of 1982, s. 3, for sub-clause (i) (w.e.f. 1-2-1983).
10. Subs. by Act 13 of 1964, s. 2 for “vermins” (w.e.f. 15-9-1964).
11. Ins. by Act 68 of 1982, s. 3 (w.e.f. 1-2-1983).
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1[(c) “Government Analyst ” means —
(i) in relation to 2[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;]
3* * * * *
4[(e) “Inspector ” means —
(i) in relation to 2[Ayurvedi c, 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 ;]
5[ 6[(f)] “manufacture ” in relation to any dr ug 7[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 7[or cosmetic] with a view to its 8[sale or distribution] but does
not include the compounding or dispensing 9[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;]
10[(g)] “to import ”, with its grammatical variations and cognate expressions means to bring into
11[India];
12[ 10[(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 formulae described in the
authoritative books of Ayurvedic, Siddha or Unani Tibb systems of medicine specified in
the First Schedule, but does not include a medicine which is administered by parenteral
route and also a formulation included in the authoritative books 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
Governm ent after consultation with the Drugs Technical Adivisory Board constituted
under section 5;]
13[ 10[( i)] “prescribed ” means prescribed by rules made under this Act.]
1. Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
3. Cl. (d) omitted by Act 19 of 1972, s. 3.
4. Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).
5. Cl. (bbb) ins. by Act 11 of 1955, s. 2.
6. Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).
7. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).
8. Subs. by Act 68 of 1982, s. 3, “sale and distribution” (w.e.f. 1-2-1983).
9. Subs. by Act 21 of 1962, s. 4, for “or packing of any drug”.
10. Cls. (c), (d) and (e) relettered as cls. (g), (h) and (i) respectively by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).
11. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
12. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983).
13. Subs. by Act 11 of 1955, s. 2, for original cl. (e).
7
1* * * * *
2[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 IV 3[or Chapter IVA ] shall be deemed to be a poisonous
substance for the purposes of Chapter III or Chapter IV 3[or Chapter IVA], as the case may be.
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 administ ration of
this Act and to carry out the other functions assigned to it by this Act.
4[( 2) The Board shall consist of the following members, namely :—
(i) the Director General of Health Services, ex officio, who shall be the 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;
(vi i) 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 pharmacologist to be elected by the Governing Body of the Indian Council of Medical
Research;
1. Cl. (f) omitted by Act 3 of 1951, s. 3 and Sch.
2. Ins. by Act 19 of 1972, s. 4.
3. Ins. Act 13 of 1964, s. 3 (w.e.f. 15-9-1964).
4. Subs. by s. 4, ibid., for sub-section (2) (w.e.f. 15-9-1964).
8
(xiv ) one person to be elected by the Central Council of the Indian Medical
Association;
(xv) one person to be elected by the Council of the Indian Pharmaceutical
Association;
(xvi) two persons holding the appointment of Government Analyst under this Act, to be
nominated by the Central Government.]
(3) The nominated and elected members of the Board shall hold office for three years, but shall be
eligible for re-nomination and re-election :
1[Provided that the person nominated or elected, as the case may be, under clause (ix) or
clause ( x) or clause (xi) or 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
transa cted 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 Centra l Government shall, as soon as may
be, establish a Central Dru gs 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 th e Central Drugs
Laboratory in respect of any drug or class of drugs 2[or cosmetic or class of cosmetics] shall be
carried out at the Central Research Institute , Kasauli, or at any other prescribed Laboratory and
the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of
drugs 2[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 ;
3* * * * *
(d) the procedure for the submission to the said Laboratory 4[under Chapter IV or
Chapter IVA] of samples of drugs 2[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).
1. Subs. by Act 13 of 1964, s. 4, for the proviso (w.e.f. 15-9-1964).
2. Ins. by Act 21 of 1962, s. 5 (w.e.f. 27-7-1964).
3. Cls. (b) and (c) omitted by Act 11 of 1955, s. 4.
4. Subs. by Act 13 of 1964, s. 5, for “under Chapter IV” (w.e.f. 15-9-1964).
9
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 througho ut 1[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.
2[7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs. —Nothing contained
in sections 5 and 7 shall apply to 3[Ayurvedic, Siddha or Unani] drugs.]
CHAPTER III
4[IMPORT OF DRUGS AND COSMETICS]
8. Standards of quality. —5[(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 6[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 6[the Second Schedule], for the purposes of this Chapter,
and thereupon 6[the Second Schedule] shall be deemed to be amended accordingly.
7[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 labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement, design
or device which makes any false claim for the drug or which is false or misleading in any
particular.]
8[9A. 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
1. Subs. by Act 3 of 1951, s. 3 and the Sch., for “the States”.
2. Ins. by Act 13 of 1964, s. 6 (w.e.f. 15 -9-1964).
3. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).
4. Subs. by s. 4, ibid., for the heading under Chapter III (w.e.f. 1-2-1983).
5. Subs. by Act 21 of 1962, s. 2, for sub-section (1) (w.e.f. 27-7-1964).
6. Subs. by Act 13 of 1964, s. 7, for “the Schedule” (w.e.f. 15-9-1964).
7. Subs. by Act 68 of 1982, s. 5, for section 9 (w.e.f. 1-2-1983).
8. Subs. by s. 6, ibid., for sections 9A and 9B (w.e.f. 1-2-1983).
10
(c) if its container is composed in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to hea lth; 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 container the name of another
drug unless it is plainly and conspicuously marked so as to reveal its tru e 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
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 labelled 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 wit h 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 product of a manufacture of whom it is not truly a product.]
10. Prohibition of import of certain drugs or cosmetics. —From such date 1 as may be fixed
by the Central Government by notification in the Official Gazette in this behalf, no person shall
import —
1. 1st April, 1947, for cls. (a), (b), (c), (e) and (f) and 1st April, 1949, for cl. (d), see notification No. 18-12-46-D-I, dated the 11th
February, 1947, Gazette of India, 1947, Pt. I, p 189 as amended by notification No. F-1-2/48-D(I), dated the 29th September,
1948, 1st April, 1953, for the State of H.P., Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur vide notification
No. S.R.O. 666, dated the 30th March, 1953, Gazette of India, 1953, Pt. II, Sec. 3, p. 451.
11
(a) any drug 1[or cosmetic] which is not of standard quality;
2[( b) any misbranded drug 3[or misbranded or spurious cosmetics] ;]
4[(bb) any 5[adulterated or spurious ;] drug ;]
(c) any drug 1[or cosmetic] for the import of which a licence is prescribed, otherwise
than under, in accordance with, such licence;
6[(d) any patent or proprietary medicine, unless there is displayed in the prescribed
manner on the label or container thereof 7[the true formula or list of active ingredients con -
tained in it together with the quantities there of];]
(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;
1[(ee ) any cosmetic containing any ingredient which may render it unsafe or
harmful for use under the directions indicated or recommended;]
(f) any drug 1[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 con -
ditions, of small quantities of any drug for the purpose of examination, test or ana lysis 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
notifica tion, the import of any drug or class of drugs not being of standard quality.
8* * * * *
9[10A. 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 pro-
hibited by section 18 of the Sea Customs Act, 1878 10 (18 of 1878) shall, subject to the provisions
of section 13 of this Act, apply in respect of drugs 11[and cosmetics] the import of which is
prohibite d under this Chapter and officers of Customs and officers empowered under that Act
to perform the duties imposed thereby on a 12[Commissioner of Customs] and other officers of
1. Ins. by Act 21 of 1962, s. 8 (w.e.f. 27 -7-1964).
2. Subs. by s. 8, ibid., for clause (b) (w.e.f. 27-7-1964).
3. Subs. by Act 68 of 1982, s. 7, for “or misbranded cosmetic” (w.e.f. 1 -2-1983).
4. Ins. by Act 13 of 1964, s. 9 (w.e.f. 15 -9-1964).
5. Subs, by Act 68 of 1982; s. 7, for “adulterated” (w.e.f. 1 -2-1983).
6. Subs. by Act 11 of 1955, s. 5, for cl ause (d).
7. Subs. by Act 68 of 1982, s. 7, for certain words (w.e.f. 1-2-1983).
8. The Explanation omitted by Act 68 of 1982, s. 7 (w.e.f. 1 -2-1983).
9. Ins. by s. 8, ibid. (w.e.f. 1-2-1983).
10. Now see the Customs Act, 1962.
11. Ins. by Act 21 of 1962, s. 9 (w.e.f. 27-7-1964).
12. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”.
12
Customs, shall have the same powers in respect of such drugs 1[and cosmetics] as they have for the time
being in respect of such goods as aforesaid.
2[(2) Without prejudice to the provisions of sub -section (1), the 3[Commissioner of
Cus toms] or any officer of the Government authorised by the Central Government in this
behalf, may detain any imp orted package which he suspects to contain any drug 1[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 p ackage or
sample of any suspected drug 1[or cosmetic] found therein to the Central Drugs Laboratory.]
12. Power of Central Government to make rules. —(1) The Central Government may,
4[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
pro visions of this Chapter :
5[Provided that consultation with the Board may be dispensed with if the Central
Govern ment 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 o f the rules and the Central Government shall take into consideration
any sugges tions 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 6[or cosmetics or classes of cosmetics] for the
import of which a licence is required, 7[and prescribed the form and conditions of such
licences, the authority empowered to issue the same, the fees payable therefor and provide
for the cancellation, or suspension of such licence in any case where any provision of this
Chapter or the rules made thereunder is contravened or any of the conditions subject to
which the licence is issued is not complied with] ;
(b) prescribe the methods of test or analysis to be employed in determining whether a drug
6[or cosmetic] is of standard quality ;
(c) prescribe, in respect of biological and organometallic compounds, the units or methods of
standardisation;
8[(cc) prescribe under clause ( d) of 9[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
10[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 6[or cosmetic s] may be imported, and prohibited their
import at any other place;
1. Ins. by Act 21 of 1962, s. 9 (w.e.f. 27-7-1964).
2. Subs. by Act 11 of 1955, s. 6, for sub-section (2).
3. Subs. by Act 22 of 1995, s. 83, for “Customs Collector”.
4. Subs. by Act 68 of 1982, s. 9, for “after consultation with the Board” (w.e.f. 1-2-1983).
5. Ins. by Act 11 of 1955, s. 7.
6. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964).
7. Subs. by Act 68 of 1982, s. 9, for certain words (w.e.f. 1-2-1983).
8. Ins. by Act 13 of 1964, s. 10 (w.e.f. 15-9-1964).
9. Subs. by Act 68 of 1982, s. 9, for “section 9B” (w.e.f. 1-2-1983).
10. Subs. by Act 11 of 1955, s. 7 for “to cure or mitigate”.
13
(g) require the date of manufacture and the date of expiry of potency to be clearly and
truely 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;
(h) regulate the submission by importers, and the securing, o f samples of drugs
1[or cosmetics] for examination, test or anal ysis by the Central Drugs Laboratory, and
pres cribed 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 1[or cosmetics] sought to be imp orted, the procedure of
officers of Customs in dealing with such evidence, and the manner of storage at places of
import of drugs l[or cosmetics] detained pending admission;
(j) provide for the exemption, conditionally or otherwise, from all or any of the pro visions
of this Chapter and the rules made thereunder of drugs 1[or cosmetics] imported for the
purpose only of transport through, and export from, 2[India];
(k) prescribe the conditions to be observed in the packing in bottles, packages or other
containers, of imported drugs 1[or cosmetics] 3[including the use of packing material which comes
into direct contact with the drugs];
(l) regulate the mode of labelling drugs 1[or cosmetics] imported for sale in packages, and
prescribe the matters which shall or shall not be included in such labels;
(m) prescribe the maxim um 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 Ch apter 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 pro visions of
this Chapter or the rules made thereunder of any specified drug or class of drugs l[or cosmetics or
class of cosmetics].
4[13. Offenees. —(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 sec tion 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;
(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.
1. Ins. by Act 21 of 1962, s. 10 (w.e.f. 27-7-1964).
2. Subs. by Act 3 of 1951, s. 3 and Sch., for “the States”.
3. Ins. by Act 68 of 1982, s. 9 (w.e.f. 1-2-1983).
4. Subs. by s. 10, ibid., for section 13 (w.e.f. 1-2-1983).
14
(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 1[or cosmetics] in respect of which the offence has been committed shall be
liable to confiscation.
15. Jurisdiction.—No Court inferior to that 2[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 3[DRUGS AND COSMETICS]
16. Standards of quality. —4[(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 5[the Second
Schedule], and
(b) in relation to a cosmetic, that the cosmetic complies with such stand ard as may
be prescribed.]
(2) The 6[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 5[the Second Schedule] for the purposes
of this Chapter, and thereupon 5[the Second Schedule] shall be deemed to be amended
accordingly.
7[17. 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 no t labelled in the prescribed manner; or
(c) if its label or container or anything accompanying the drug bears any statement,
design or device which makes any false claim for the drug or which is false or misleading in
any particular.
1. Ins. by Act 21 of 1962, s. 11 (w.e.f. 27-7-1964).
2. Subs. by Act 68 of 1982, s. 11, for certain words (w.e.f. 1-2-1983).
3. Subs. by s. 12, ibid., for “DRUGS” (w.e.f. 1-2-1983).
4. Subs. by Act 21 of 1962, s. 12, for sub-section (1) (w.e.f. 27-7-1964).
5. Subs. by Act 13 of 1964, s. 11, for “the Schedule” (w.e.f. 15-9-1964).
6. Subs. by Act 11 of 1955, s. 8, for “State Government”.
7. Subs. by Act 68 of 1982, s. 13, for sections 17, 17A and 17B (w.e.f. 1-2-1983).
15
17A. 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.
17B. 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.
17C. 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 labelled in the prescribed manner; or
(c) if the label or container or anything accompanying the cosmetic bears any state -
ment which is false or misleading in any particular.
17D. 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 label or container the
name of another cosmetic unless it is plainly and conspicuously marked so as to re veal 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.]
16
1[17E. 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 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 conExcerpt shown. Open the full act in Lexace.