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Section 3 – The Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940

 

 

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.

 

————————

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.

 

 

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The Drugs and Cosmetics Act, 1940

 

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