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 date6
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 date8
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.]
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 States of Delhi. Ajmer and Coorg on the 1st 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 1st 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. 1st 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.
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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 (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
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;]
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
[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 ;]
5
[
6
[(f)] “manufacture” in relation to any drug 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
Government 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).
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* * * * *
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.