Section 3 Drugs And Costmetics Act, Sec 3 of DCA
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3. Defini tions. —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;]
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 relat ion 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 cosmet ic, an Inspector appointed by the
Central Government or a State Government under sect ion 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.]
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