X

Drugs and Cosmetics Act, 1940 - Definitions

J E
Indian Laws and Regulations Related to Health

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))].

(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
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;

(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 33G; and

(ii) in relation to any other drug or cosmetic, a Government Analyst appointed by the Central Government or a State Government under section 21;

(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 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 or cosmetic includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business; and “to manufacture” shall be consrued 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.)

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
User Avatar
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions
san15
Please confirm whether the drug is in JP and not in IP , is it mandatory to claim JP?
san15  Tuesday, December 18, 2012
mtcgases
there are people who are using a single liquid oxygen tank for both medical and industrial oxygen, and theboth grades liquid oxygen is being transported in the same transport tank, both the grades of oxygen are filled from the same filling manifold, even the liquid oxygen is being imported from bhutan and sold in india, Is it legal as per indian Drug Act.
mtcgases  Saturday, September 22, 2012
Shwetaracha06
Hi, Mohanjeeva We would like to have your contact details..(Regarding tooth powder)Plz rply or you can mail me mail id : rachashweta06@gmail.com
Shwetaracha06  Wednesday, September 19, 2012
Mohanjeeva
Sir
We are 100% Merchandise Exporter for the past 10years .We are having a sample Ash tooth powder and we want the detailed test report for the following items in terms of percentage :
1) Ash
2) Potash Alum
3) Menthol
4) Thaimol
5) Amaranth Dye
6) Propylene Glycol
7) Industrial Sweetener (Sacrin)
Kindly advise us to whom we have to proceed for the above particulars .
Awaiting your early reply .
Rgds
Mohanjeeva  Wednesday, August 29, 2012
indianguy
sir, where can i get the information of schedule T for manufacturing of an ayurvedic drugs.
indianguy  Wednesday, August 22, 2012
View all Comments (15)

Most Popular News on Medindia

P
M
s
Drugs and Cosmetics Act, 1940 - The Central Drugs ...
S
Drugs and Cosmetics Act, 1940 - Introduction