The Drugs and Cosmetics Act, 1940

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1. Short title, extent and commencement-

(1) This Act may be called the Drugs ¹[and Cosmetics] Act, 1940.
(2) It extends to the whole of India ²[***].
(3) It shall come into force at once; but Chapter III shall take effect only from such date³ 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 date3 as the State Government may, by like notification, appoint in this behalf:
⁴[Provided that in relation to the State of Jammu and Kashmir, Chapter III shall take effect only from such date⁵ after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this behalf.]
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1. Ins. by Act 21 of 1962, sec. 3 (w.e.f. 27-7-1964).
2. The words “except the State of Jammu and Kashmir” omitted by Act 19 of 1972, sec. 2 (w.e.f. 31-5-1972).
3. 1st April, 1947; see Notification No.F. 28(10) (3) 45H(I), dated 2nd September, 1946, Gazette of India, 1946, Pt. I, p. 1349.
Chapter IV came into force in the States of Delhi, Ajmer and Coorg on 1st April, 1947, see Notification No. F. 28 (10)(3) 45H(I), Chapters III and IV came into force in the States of Himachal Pradesh, Bilaspur, Kutch, Bhopal, Tripura, Vindhya Pradesh and Manipur on 1st April, 1953, vide Notification No. S.R.O. 663, dated 30th March, 1953, Gazette of India, Pt. II, Sec. 3, p. 451.
Chapter IV came into force in the Union Territory of Dadra and Nagar Haveli w.e.f. 1st August, 1968, see Notification No. ADM/Law/117(74), dated 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, sec. 2 and Sch. I; to Pondicherry by Reg. 7 of 1963, sec. 3 and Sch. I; to Goa, Daman and Diu by Reg. 11 of 1963, sec. 3 and Sch. and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965, sec. 3 and Sch.
4. Added by Act 19 of 1972, sec. 2 (w.e.f. 31-5-1972).
5. 24th August, 1974, vide Notification No. S.O. 2185, dated 9th August, 1974, published in the Gazette of India, 1974, Pt. II, Sec. 3(ii), p. 2331.

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. –

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 ⁴[Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]
⁵[(aa)] “the Board” means—
(i) in relation to ²[Ayurvedic, Siddha or Unani] drug, the ⁶[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[⁷[(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 ⁸[***];]
⁹[(b) “drug” includes—
¹⁰[(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;]
(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of ¹¹[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;]
¹²[(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;]
¹³[(c) “Government Analyst” means—
(i) in relation to ¹⁴[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;]
¹⁵[***]
¹⁶[(e) “Inspector” means—
(i) in relation to ¹⁴[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;]
¹⁷[(f) “manufacture” in relation to any drug ¹⁸[or cosmetic] includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug ¹³[or cosmetic] with a view to its ¹⁹[sale or distribution] but does not include the compounding or dispensing ²⁰[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;]
²¹[(g)] “to import”, with its grammatical variations and cognate expressions means to bring into ²²[India];
²³[(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 Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books 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;]
²⁴[(i) “prescribed” means prescribed by rules made under this Act.]
²⁵[***]
COMMENTS
(i) It is not necessary that the article should be applied to the whole body. If it is applied to a part of the body and if it beautifies or promotes attractiveness or alters appearance then also it will be a cosmetic within the meaning of the Drugs and Cosmetics Act, 1940; State of Bombay v. Zahid Hussain, 1975 Mah LJ 455.
(ii) ‘Gandh’ and ‘nail polish’ are ‘cosmetics’ within the meaning of the Act; State of Bombay v. Zahid Hussain, 1975 Mah LJ 455.
(i) The definition of ‘drug’ is an inclusive one. It includes all medicines for external or internal use of human beings or animals or any substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals; Langamurti v. State of Orissa, (1973) 1 CWR 368.
(ii) The appropriate meaning of the expression ‘substances’ in the section is things; Chimanlal J. Sheth v. State of Maharashtra, AIR 1963 SC 665.
(iii) Water meant to be used for dissolving other medicines for injection into human body is ‘drug’; R.C. Sundarka v. State of West Bengal, 1971 Cr LJ 1369: 77 CWN 437.
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1.Ins. by Act 13 of 1964, sec. 2 (w.e.f. 15-9-1964)
2.Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
3.Subs. by Act 68 of 1982, sec. 3, for “disease in human beings, mentioned in, and processed and manufactured” (w.e.f. 1-2-1983).
4.Subs. by Act 68 of 1982, sec. 3, for “Ayurvedic (including Siddha) and Unani (Tibb) system of medicine” (w.e.f. 1-2-1983).
5.Original clause (a) relettered as clause (aa) and subs. by Act 13 of 1964, sec. 2 (w.e.f. 15-9-1964).
6.Subs. by Act 68 of 1982, sec. 3, for “Ayurvedic and Unani Drugs Technical Advisory Board” (w.e.f. 1-2-1983)
7.Clause (aa) ins. by Act 21 of 1962, sec. 4 (w.e.f. 27-7-1964) and relettered as clause (aaa) by Act 13 of 1964, sec. 2 (w.e.f. 15-9-1964).
8.The words “, but does not include soap” omitted by Act 68 of 1982, sec. 3 (w.e.f. 1-2-1983).
9.Subs. by Act 11 of 1955, sec. 2, for clause (b) (w.e.f. 15-4-1955).
10.Subs. by Act 68 of 1982, sec. 3, for sub-clause (i) (w.e.f. 1-2-1983).
11.Subs. by Act 13 of 1964, sec. 2, for “vermins” (w.e.f. 15-9-1964).
12.Ins. by Act 68 of 1982, sec. 3 (w.e.f. 1-2-1983).
13.Subs. by Act 13 of 1964, sec. 2, for clause (c) (w.e.f. 15-9-1964).
14.Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).
15.Clause (d) omitted by Act 19 of 1972, sec. 3 (w.e.f. 31-5-1972).
16.Subs. by Act 13 of 1964, sec. 2, for clause (e) (w.e.f. 15-9-1964).
17.Clause (bbb) ins. by Act 11 of 1955, sec. 2 (w.e.f. 15-4-1955) and relettered as clause (f) by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961)
18.Ins. by Act 21 of 1962, sec. 4 (w.e.f. 27-7-1964).
19.Subs. by Act 68 of 1982, sec. 3, for “sale and distribution” (w.e.f. 1-2-1983)
20.Subs. by Act 21 of 1962, sec. 4, for “or packing of any drug”.
21.Clauses (c), (d) and (e) relettered as clauses (g), (h) and (i) respectively by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961).
22.Subs. by Act 3 of 1951, sec. 3 and Sch., for “the States”.
23.Clause (d) relettered as clause (h) by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961) and subs. by Act 68 of 1982, sec. 3 (w.e.f. 1-2-1983).
24.Clause (e) subs. by Act 11 of 1955, sec. 2 (w.e.f. 15-4-1955) and relettered as clause (i) by Act 35 of 1960, sec. 2 (w.e.f. 16-3-1961).
25.Clause (f) ins. by the A.O. 1950 and omitted by Act 3 of 1951, sec. 3 and Sch.
* The Central Government has specified (vide S.O. 1468(E), dated 6th October, 2005) the following devices intended for external or internal use in human beings or drugs with immediate effect, namely:—
(i) Cardiac Stents (vi) Bone Cements
(ii) Drug Eluding Stents (vii) Heart Valves
(iii) Catheters (viii) Sclap Vein Set
(iv) Intra Ocular Lenses (ix) Orthopaedic Implants
(v) I.V. Cannulac (x) Internal Prosthetic Replacements.

3A. Constitution of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir. –

¹[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.
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1. Ins. by Act 19 of 1972, sec. 4 (w.e.f. 31-5-1972).

4. Presumption as to poisonous substances. –

Any substance specified as poisonous by rule made under Chapter III or Chapter IV ¹[or Chapter IVA] shall be deemed to be a poisonous substance for the purpose of Chapter III or Chapter IV 1[or Chapter IVA], as the case may be.
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5.The Drugs Technical Advisory Board. –

¹[(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 pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;
(xiv) one person to be elected by the Central Council of the Indian Medical Association;
(xv) one person to be elected by the Council of the Indian Pharmaceutical Association;
(xvi) two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government.]
(3) The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election:
²[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 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.
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1. Subs. by Act 13 of 1964, sec. 4, for sub-section (2) (w.e.f. 15-9-1964).
2. Subs. by Act 13 of 1964, sec. 4, for the Proviso (w.e.f. 15-9-1964).

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 ¹[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 ¹[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;
²[***]
(d) the procedure for the submission of the said Laboratory ³[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).
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1. Ins. by Act 21 of 1962, sec. 5 (w.e.f. 27-7-1964).
2. Clauses (b) and (c) omitted by Act 11 of 1955, sec. 4 (w.e.f. 15-4-1955).
3. Subs. by Act 13 of 1964, sec. 5, for “under Chapter IV” (w.e.f. 15-9-964).

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 throughout 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.
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1. Ins. by Act 3 of 1951, sec. 3 and Sch., for “the States”.

7A. Section 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs. –

¹[7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs.—
Nothing contained in sections 5 and 7 shall apply to 2[Ayurvedic, Siddha or Unani] drugs.]
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1. Ins. by Act 13 of 1964, sec. 6 (w.e.f. 15-9-1964).
2. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).

8. Standards of quality. –

¹[(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 ²[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 ²[the Second Schedule], for the purposes of this Chapter, and thereupon ²[the Second Schedule] shall be deemed to be amended accordingly.
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1. Subs. by Act 21 of 1962, sec. 6, for sub-section (1) (w.e.f. 27-7-1964).
2. Subs. by Act 13 of 1964, sec. 7, for “the Schedule” (w.e.f. 15-9-1964).

9. Misbranded drugs. –

¹[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.]
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1. Subs. by Act 68 of 1982, sec. 5, for section 9 (w.e.f. 1-2-1983).

9A. Adulterated drugs. –

¹[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
(c) If its contained 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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1. Section 9A ins. by Act 21 of 1962, sec. 7 and subs. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).

9B. Spurious drugs. –

¹9B. 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
(e) If it purports to be the product of a manufacturer of whom it is only truly a product.
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1. Section 9B ins. by Act 13 of 1964, sec. 8 (w.e.f. 15-9-1964) and subs. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).

9C. Misbranded Cosmetics. –

¹9C. 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.
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1. Ins. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).

9D. Spurious cosmetics. –

¹[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.]
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1. Ins. by Act 68 of 1982, sec. 6 (w.e.f. 1-2-1983).

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

From such date¹ as may be fixed by the Central Government by notification in the Official Gazette in this behalf, no person shall import—
(a) any drug ²[or cosmetic] which is not of standard quality;
³[(b) any misbranded drug ⁴[or misbranded or spurious cosmetic];]
⁵[(bb) any ⁶[adulterated or spurious] drug;]
(c) any drug ²[or cosmetic] for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence;
⁷[(d) any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof ⁸[the true formula or list of active ingredients contained in it together with the quantities thereof];]
(e) any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any such disease or ailment, or to have any such other effect, as may be prescribed;
⁹[(ee) any cosmetic containing any ingredient which may render it unsafe or harmful or 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 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[***]
COMMENTS
Any import of goods, of which the importation is prohibited by law, cannot be a valid import under the Act. So, goods so imported cannot be treated to be lawfully ‘imported goods’; S. Mohammed v. Asstt. Collector, Customs, AIR 1970 Cal 134.
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1.1st April, 1947, for clauses (a), (b), (c), (e) and (f) and 1st April, 1949, for clause (d), see Notification No. 18-12-46-D.I., dated 11th F

Wednesday, October 23, 2013