Section 3 of Drugs and Cosmetics Act 1940 - Definitions

Section 3 Definitions: Drugs and Cosmetics Act 1940

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 article 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 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 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 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;]

12[(c) "Government Analyst" means-

(i) in relation to 13[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 13[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[ 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, labeling, breaking up or otherwise treating or adopting any drug 18[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[ 21[(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 Government after consultation with the Drugs Technical Adivisory Board constituted under section 5;]

24[ 21[(i)] "prescribed" means prescribed by rules made under this Act.]
25* * * * *


 

 

----------

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).

12. Subs. by Act 13 of 1964, s. 2, for cl. (c) (w.e.f. 15-9-1964).

13. Subs. by Act 68 of 1982, s. 2, for certain words (w.e.f. 1-2-1983).

14. Cl. (d) omitted by Act 19 of 1972, s. 3.

15. Subs. by Act 13 of 1964, s. 2, for cl. (e) (w.e.f. 15-9-1964).

16. Cl. (bbb) ins. by Act 11 of 1955, s. 2.

17. Cl. (bbb) relettered as cl. (f) by Act 35 of 1960, s. 2 (w.e.f. 16-3-1961).

18. Ins. by Act 21 of 1962, s. 4 (w.e.f. 27-7-1964).

19. Subs. by Act 68 of 1982, s. 3, "sale and distribution" (w.e.f. 1-2-1983).

20. Subs. by Act 21 of 1962, s. 4, for "or packing of any drug".

21. 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).

22. Subs. by Act 3 of 1951, s. 3 and Sch., for "the States".

23. Subs. by Act 68 of 1982, s. 3, for cl. (h) (w.e.f. 1-2-1983).

24. Subs. by Act 11 of 1955, s. 2, for original cl. (e).

25. Cl. (f) omitted by Act 3 of 1951, s. 3 and Sch.