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THE DRUGS AND COSMETICS ACT, 1940

Title : THE DRUGS AND COSMETICS ACT, 1940

Year : 1940

[Act, No. 23 of 1940]1*
[10th April, 1940]
PREAMBLE

An Act to regulate the import, manufacture, distribution and sale of drugs2*[and cosmetics].

WHEREAS it is expedient to regulate the3*[import, manufacture, distribution and sale] of drugs2*[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 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:-

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1. For Statement of Objects and Reasons, see Gazette of India, 1940, Pt. V, p. 34; for the Report of the Select Committee, see Gazette of India, 1940, Pt. V. p. 143.

The Act has been applied to all the partially excluded areas in the State of Orissa, see Orissa Government Notification No. 3358-LSG, dated 25th August, 1941.

2. Inserted by Act 21 of 1962, Section 2 (w.e.f. 27-7-1964).

3. Substituted by the A.O. 1950, for certain words.

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(1) This Act may be called the Drugs1*[and Cosmetics] Act, 1940.

(2) It extends to the whole of India2[* * *].

(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 date6 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. Inserted by Act 21 of 1962, Section 3 (w.e.f. 27-7-1964).

2. The words "except the State of Jammu and Kashmir" omitted by Act 19 of 1972, Section 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, Section 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, Section 3, p. 128. The Act is extended to Dadra and Nagar Haveli by Reg. 6 of 1963, Section 2 and Schedule I; to Pondicherry by Reg. 7 of 1963, Section 3 and Schedule I; to Goa, Daman and Diu by Reg. 11 of 1963, Section 3 and Schedule and to Laccadive, Minicoy and Amindivi Islands by Reg. 8 of 1965, Section 3 and Schedule

4. Added by Act 19 of 1972, Section 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, Section 3(ii), p. 2331.

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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.



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 4*[Ayurvedic, Siddha and Unani Tibb system 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 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;]

14 [* * *]

15*[(e) "Inspector" means-

(i) In relation to 4*[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;]

16*[(f) "Manufacture" in relation to any drug 17*[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 18* [sale or distribution] but does not include the compounding or dispensing 19*[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;]

20*[(g)] "To import", with its grammatical variations and cognate expressions means to bring into 21 [India];

22*[(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;]

23*[(i) "prescribed" means prescribed by rules made under this Act.]

24 [* * *]

3A - 25* 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. Inserted by Act 13 of 1964, Section 2 (w.e.f. 15-9-1964).

2. Substituted by Act 68 of 1982, Section 2, for "Ayurvedic (including Siddha) or Unani" (w.e.f. 1-2-1983).

3. Substituted by Act 68 of 1982, Section 3, for "disease in human beings, mentioned in, and processed and manufactured" (w.e.f. 1-2-1983).

4. Substituted by Act 68 of 1982, Section 3, for "Ayurvedic (including Siddha) or Unani (Tibb) system of medicine" (w.e.f. 1-2-1983).

5. Original clause (a) relettered as clause (aa) and Substituted by Act 13 of 1964, Section 2 (w.e.f. 15-9-1964).

6. Substituted by Act 68 of 1982, Section 3, for "Ayurvedic and Unani Drugs Technical Advisory Board" (w.e.f. 1-2-1983).

7. Clause (aa) Inserted by Act 21 of 1962, Section 4 (w.e.f. 27-7-1964) and relettered as clause (aaa) by Act 13 of 1964, Section 2 (w.e.f. 15-9-1964).

8. The words "but does not include soap" omitted by Act 68 of 1982, Section 3 (w.e.f. 1-2-1983).

9. Substituted by Act 11 of 1955, Section 2, for clause (b) (w.e.f. 15-4-1955).

10. Substituted by Act 68 of 1982, Section 3, for sub-clause (i) (w.e.f. 1-2-1983).

11. Substituted by Act 13 of 1964, Section 2, for "vermins" (w.e.f. 15-9-1964).

12. Inserted by Act 68 of 1982, Section 3 (w.e.f. 1-2-1983).

13. Substituted by Act 13 of 1964, Section 2, for clause (c) (w.e.f. 15-9-1964).

14. Clause (d) omitted by Act 19 of 1972, Section 3 (w.e.f. 31-5-1972).

15. Substituted by Act 13 of 1964, Section 2 for clause (e) (w.e.f. 15-9-1964).

16. Clause (bbb) Inserted by Act 11 of 1955, Section 2 (w.e.f. 15-4-1955) and relettered as clause (f) by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961)

17. Inserted by Act 21 of 1962, Section 4 (w.e.f. 27-7-1964).

18. Substituted by Act 68 of 1982, Section 3, for "sale and distribution" (w.e.f. 1-2-1983)

19. Substituted by Act 21 of 1962, Section 4, for "or packing of any drug".

20. Clauses (c), (d) and (e) relettered as clauses (g), (h) and (i) respectively by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961).
21. Substituted by Act 3 of 1951, Section 3 and Schedule, for "the States".

22. Clause (d) relettered as clause (h) by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961) and Substituted by Act 68 of 1982, Section 3 (w.e.f. 1-2-1983).

23. Clause (e) Substituted by Act 11 of 1955, Section 2 (w.e.f. 15-4-1955) and relettered as clause (i) by Act 35 of 1960, Section 2 (w.e.f. 16-3-1961).

24. Clause (f) Inserted by the A.O. 1950 and omitted by Act 3 of 1951, Section 3 and Schedule.

25. Inserted by Act 19 of 1972, Section 4 (w.e.f. 31-5-1972).

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Any substance specified as poisonous by rule made under Chapter III or Chapter IV1[or Chapter IVA] shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV1*[or Chapter IVA], as the case may be.

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1. Inserted by Act 13 of 1964, Section 3 (w.e.f. 15-9-1964).

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Last updated on July, 2016

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