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THE DRUGS AND COSMETICS ACT, 1940 (INDIA)

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 date 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 date as the State Government may, by like notification, appoint in this behalf:

Provided that in relation to the State of Jammu and Kashmir, Chapter II shall take effect only from such date 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) ” [1] [Ayurvedic Siddha or Unani] drugs” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of [2] [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 systems of medicine, specified in the First Schedule;]

(aa) “the Board” means —

(i) in relation to [4] [Ayurvedic, Siddha or Unani drug] the [5] [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, powered, 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, [6] [***]

(b) “drug” includes —

[7] [(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for on 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;] [8] [(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 [9] [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. [10] [*******]

(e) “Inspector” means —

(i) in relation to [11] [Ayurvedic, Sidha 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 and drug for 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 [12] [sale or distribution] but does not include the compounding or dispensing [13] [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;

[14] [(h) “patent or proprietory medicine” means, —

(i) in relation to Ayurvedic, Sidha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae 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 parenterate 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) “prescribed” means prescribed by rules made under this Actea

3A. Construction of references to any law not in force or any functionary not in existence in the State of Jammu and Kashmir. – Any reference in this Act to any law which is not in force, or any function not in existence, in the State of Jammu and Kashmir, shall, in relation to that State, be construed as a reference to the corresponding law in force, or to the corresponding functionary in existence, in that State.

4. Presumption as to poisonous substances. – Any substance specified as poisonous by rule made under Chapter III or Chapter IV or Chapter IVA shall be deemed to be a poisonous substance for the purposes of Chapter III or Chapter IV for Chapter IVA as the case may be.

CHAPTER II-THE DRUGS TECHNICAL ADVISORY BOARD, THE CENTRAL DRUGS LABORATORY AND THE DRUGS CONSULTATIVE COMMITTEE

5. The Drugs Technical Advisory Board. – (1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Actea

2. The Board shall consist of the following members, namely: –

(i) the Director general of Health Services ex officio, who shall be Chairman;

(ii) the Drugs Controller, India, ex officio;

(iii) The Director of the Central Drugs Laboratory, Calcutta, ex officio;

(iv) The Director of the Central Research Institute, Kasauli, ex officio;

(v) the Director of the Indian Veterinary Research Institute, Izatnagar, ex officio;

(vi) the President of the Medical Council of India, ex officio;

(vii) the President of the Pharmacy Council of India, ex officio;

(viii) the Director of the Central Drug Research Institute, Lucknow, ex officio;

(ix) two persons to be nominated by the Central Government from among persons who are in charge of drugs control in the States;

(x) one person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teacher in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian University or a college affiliated thereto;

(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated thereto;

(xii) on person to be nominated by the Central Government from the pharmaceutical industry;

(xii) one pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research;

(xiv) one person to be elected by the Central Council of the Indian Medical Association;

(xv) one person to be elected by the Council of the Indian Pharmaceutical Association;

(xvi) two persons holding the appointment of Government Analyst; under this Act, to be nominated by the Central Government.

(3) The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re-nomination and re-election :

Provided that the person nominated or elected, as the case may be under clause (ix) or clause (x) or clause (xi) or clause (xvi) of sub-section (2) shall hold office for so long as he holds the appointment of the office by virtue of which he was nominated or elected to the Board.

(4) The Board may, subject to the previous approval of the Central Government, make bye-laws fixing a quorum and regulating its own procedure and the conduct of all business to be transacted by it.

(5) The Board may constitute sub-committees and may appoint to such sub-committees for such periods, not exceeding three years, as it may decide, or temporarily for the consideration of particular matters, person who are not members of the Board.

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