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  Indian Laws and Regulations Related to Health
Drugs and Cosmetics Act, 1940 - Definitions

Introduction

Definitions

The Central Drugs Laboratory

The Drugs Consultative Committee

Prohibition of import of certain drugs or cosmetics

Standards of quality

Prohibition of manufacture and sale or certain drugs and cosmetics

Inspectors

Penalty for subsequent offences

Confiscation

Chapter not to apply to [Ayurvedic, Siddha or Unani] drugs

Power to give directions

Offences by Government Departments

First Schedule

Second Schedule

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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Posted by:  san15, India  Posted on: 12/18/2012
Please confirm whether the drug is in JP and not in IP , is it mandatory to claim JP?
Posted by:  mtcgases, India  Posted on: 9/22/2012
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.
Posted by:  Shwetaracha06,  Posted on: 9/19/2012
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
Posted by:  Mohanjeeva, India  Posted on: 8/29/2012
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
Posted by:  indianguy, India  Posted on: 8/22/2012
sir, where can i get the information of schedule T for manufacturing of an ayurvedic drugs.
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