Section 3 Drugs And Costmetics Act, 1940

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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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