Drugs and Cosmetics Act, 1940
3. Definitions
In this Act, unless there is anything repugnant in the subject
or context,-
9 [(a) "10[Ayurvedic, Siddha or Unani]
drug" includes all medicines intended for internal or external use for or
in the diagnosis, treatment, mitigation or prevention of 11[disease
or disorder in human beings or animals, and manufactured] exclusively in
accordance with the formulae described in, the authoritative books of 11[Ayurvedic,
Siddha and Unani Tibb system of medicine], specified in the First Schedule,]
12 [(aa) "the Board" means-
(i) in relation to 10[Ayurvedic,
Siddha or Unani] drug, the 11[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;]
13 [14[(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 15[***];]
16 [(b) "drug" includes-
17 [(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) intend
to affect the structure or any function of the human body or intended to be
used for the destruction of 18'[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;]
19 [(iii) all substances intended for use
as components of a drug including empty gelatine 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;]
20 [(c) "Government Analyst" means-
(i) in relation to 10[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;]
21[***]
22 [(e) "Inspector" means-
(i) in relation to 10[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;]
23 [24 (f) manufacture" in
relation to any drug 13[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 13[or
cosmetic] with a view to its 25[sale or distribution] but does not
include the compounding or dispensing 26[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;]
27 [(g)] "to import", with its grammatical
variations and cognate expressions means to bring into 28[India];
29 [(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 of 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 authorized in the behalf by the Central Government
after consultation with the Drugs Technical Advisory Board constituted under
section 5;]
30 [27[(i)] "prescribed" means
prescribed by rules made under this Act.]