Drugs and Cosmetics Act, 1940
No: 23 Dated: Apr, 10 1940
THE DRUGS AND COSMETICS ACT, 1940
ACT NO. 23 OF 1940
An Act to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
WHEREAS it is expedient to regulate the import, manufacture, distribution and sale of drugs and cosmetics;
AND WHEREAS the Legislatures of all the Provinces have passed resolutions in terms of section 3 of the Government of India Act, 1935, in relation to such of the above-mentioned matters and matters ancillary thereto as are enumerated in List II of the Seventh Schedule to the said Act:
It is hereby enacted as follows: —
CHAPTER I
INTRODUCTORY
1. Short title, extent and commencement. —(1) This Act may be called the Drugs and Cosmetics Act, 1940.
(2) It extends to the whole of India.
(3) It shall come into force at once; but Chapter III shall take effect only from such date6 as the Central Government may, by notification in the Official Gazette, appoint in this behalf, and Chapter IV shall take effect in a particular State only from such date6 as the State Government may, by like notification, appoint in this behalf :
Provided that in relation to the State of Jammu and Kashmir*, Chapter III shall take effect only from such date8 after the commencement of the Drugs and Cosmetics (Amendment) Act, 1972 (19 of 1972), as the Central Government may, by notification in the Official Gazette, appoint in this behalf.
2. Application of other laws not barred. —The provisions of this Act shall be in addition to, and not in derogation of, the Dangerous Drugs Act, 1930 (2 of 1930), and any other law for the time being in force. 3. Definitions. —In this Act, unless there is anything repugnant in the subject or context, —
(a) “ Ayurvedic, Siddha or Unani drug” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, specified in the First Schedule;
(aa) “the Board” means—
(i) in relation to Ayurvedic, Siddha or Unani drug, the 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) “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;
(b) “drug” includes—
(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 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) 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) “Government Analyst” means—
(i) in relation to 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;
(e) “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) “manufacture” in relation to any drug 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 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 construed accordingly;
(g) “to import”, with its grammatical variations and cognate expressions means to bring into India;
(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;
(i) “prescribed” means prescribed by rules made under this Act.