3. Definitions.
In this act, unless there is anything repugnant in
the subject or context, -
(a) [(Note: Ins. by Act 13 of
1964, sec.2 (w.e.f. 15-9-1964) (Note: Subs. by Act 68 of 1982, sec.2, for
certain words (w.e.f. 1-2-1983). Ayurvedic, Siddha or Unani] drugs"
includes all medicines intended for internal or external use for or in the
diagnosis, treatment, mitigation or prevention of [(Note: Subs. by Act 68 of
1982, sec.3, for certain words (w.e.f. 1-2-1983) disease or disorder in
human beings or animals, and manufactured] exclusively in accordance with the
formulate described in, the authoritative books of [ (Note: Subs. by Act 68 of
1982, sec.3, for certain words (w.e.f. 1-2-1983) Ayurvedic, Siddha and Unani
Tibb system of medicine], specified in the First Schedule;]
(aa) [(Note: Original clause (a)
was relettered as clause (aa) and substituted by Act 13 of 1964, sec.2 (w.e.f.
15-9-1964) "the Board" means�
(i) in relation to [ (Note:
Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983) Ayurvedic,
Siddha or Unani] drug, the [(Note: Subs. by Act 68 of 1982, sec.3, for certain
words (w.e.f. 1-2-1983) 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;]
[[(aaa)] (Note: Ins. by Act 21
of 1962, sec.4 (w.e.f. 27-7-1964)) (Note: Relettered by Act 13 of 1964, sec.2 (w.e.f.
15-9-1964)) "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 (Note: Certain words omitted by Act 68 of 1982, sec.3 (w.e.f.
1-2-1983))].
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 oralters appearance then
also it will be a cosmetic within the meaning of 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.
[(b) (Note: Subs. by Act 11 of
1955, sec.2, for clause (b)) "drug" includes �
[(i) (Note: Subs. by Act 68
of 1982, sec.3, for sub-clause (i) (w.e.f. 1-2-1983)) 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 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 [(Note: Subs. by Act 13 of 1964,
sec.2, for "vermins" (w.e.f. 15-9-1964) 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 ;]
[(iii) (Note: Ins. by Act 68 of
1982, sec.3 (w.e.f. 1-2-1983)) 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;]
COMMENTS
(i) The definition of 'drugs' is
an inclusive one. It includes all medicines for external or internal use of
human beings or animals or any substances itended 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) I 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.
[(c) (Note: Subs. by Act 13 of
1964, sec.2, for clause (c) (w.e.f. 15-9-1964)) "Government Analyst" means �
(i) In relation to [(Note:
Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983))
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;]
(d) (Note: Clause (d) omitted
by Act 19 of 1972, sec.3)
[(e) (Note: Subs. by Act 13 of
1964, sec.2 for clause (e) (w.e.f. 15-9-1964)) "Inspector" means�
(i) In relation to [(Note:
Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983)) 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;]
[(f) (Note: Clause (bbb) ins.
by Act 11 of 1955, sec.2) (Note: Clause (bbb) reentered as clause (f) by Act 35
of 1960, sec.2 (w.e.f. 16-3-1961) "manufacture" in relation to
any drug [(Note: Ins. by Act 21 of 1962, sec.4 (w.e.f. 27-7-1964)) 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 [ (Note: Ins. by Act 21 of 1962,
sec.4 (w.e.f. 27-7-1964)) or cosmetic] with a view to its [(Note: Subs. by Act
68 of 1982, sec.3, for "sale and distribution" (w.e.f. 1-2-1983)) sale
or distribution] but does not include the compounding or dispensing [ (Note:
Subs. by Act 21 of 1962, sec.4, for "or packing of any drug".) 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 ;]
(g)(Note: Clauses (c), (d)
and (e) reentered as clauses (g), (h) and (i) respectively by Act 35 of 1960,
sec.2 (w.e.f. 16-3-1961)). "to import", with its grammatical variations and
cognate expressions means to bring into [(Note: Subs. by Act 3 of 1951, sec.3
and Sch., for "the States".) India];
[(h)(Note: Clauses (c), (d)
and (e) reentered as clauses (g), (h) and (i) respectively by Act 35 of 1960,
sec.2 (w.e.f. 16-3-1961)). (Note: Subs. by Act 68 of 1982, sec.3, for clause (h)
(w.e.f. 1-2-1983)). "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 formulate 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
parental 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;]
[(I)] (Note: Subs. by Act 11
of 1955, sec.2, for original clause (e)) (Note: Clauses (c), (d) and (e)
reentered as clauses (g), (h) and (i) respectively by Act 35 of 1960, sec.2
(w.e.f. 16-3-1961)) "prescribed" means prescribed by rules made under this Act.]
(f) (Note: Clause (f) ins. by the A.O. 1950
and omitted by Act 3 of 1951, sec.3 and Sch.)
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