Drugs and Cosmetics Act, 1940 - The Central Drugs Laboratory

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3A. Constitution 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 functionary 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 II or Chapter IV [(Note: Ins. by Act 13 of 1964, sec.3 (w.e.f. 15-9-1964)) or Chapter IVA] shall be deemed to be a poisonous substance for the purpose of Chapter III or Chapter IV [(Note: Ins. by Act 13 of 1964, sec.3 (w.e.f. 15-9-1964)) or Chapter IVA], as the case may be.

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 Act.

[(2) (Note: Subs. by Act 13 of 1964, sec.4, for sub-section (2) (w.e.f. 15-9-1964)) 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 teachers 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) One person to be nominated by the Central Government from the pharmaceutical industry;

(xiii) One pharrmacologist 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 :

[(Note: Subs. by Act 13 of 1964, sec.4, for the Proviso (w.e.f. 15-9-1964)). Provided that the person nominated or elected, as the case may be, under clause (ix) or clause (x) or clause (xi) of 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, persons who are not members of the Board.

(6) The functions of the Board may be exercised notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person to be Secretary of the Board and shall provide the Board with such clerical and other staff as the Central Government considers necessary.

6. The Central Drugs Laboratory. – (1) The Central Government shall, as soon as may be, establish a Central Drugs Laboratory under the control of a Director to be appointed by the Central Government, to carry out the functions entrusted to it by this Act or any rules made under this Chapter :

Provided that, if the Central government so prescribes, the functions of the Central Drugs Laboratory in respect of any drug or class of drugs [(Note: Ins. by Act 21 of 1962, sec.5 (w.e.f. 27-7-1964)) or cosmetic or class of cosmetics] or class of cosmetics] shall be carried out at the Central Research Institute, Kasauli, or at any other prescribed Laboratory and the functions of the Director of the Central Drugs Laboratory in respect of such drug or class of drugs [(Note: Ins. by Act 21 of 1962, sec.5 (w.e.f. 27-7-1964)) or such cosmetic or class of cosmetics] shall be exercised by the Director of that Institute or of that other Laboratory, as the case may be.

(2) The Central Government may, after consultation with the Board, make rules prescribing-

(a) The functions of the Central Drugs Laboratory ;

(b) (Note: Clause (b) omitted by Act 11 of 1955, sec.4)

(c) (Note: Clause (c) omitted by Act 11 of 1955, sec.4)

(d) The procedure for the submission of the said Laboratory [ (Note: Subs. by Act 13 of 1964, sec.5, for "under Chapter IV" (w.e.f. 15-9-1964)) under Chapter IV or Chapter IVA] of samples of drugs [(Note: Ins. by Act 21 of 1962, sec.5 (w.e.f. 27-7-1964)) or cosmetics] for analysis or test, the forms of the Laboratory’s reports thereon and the fees payable in respect of such reports ;

(e) Such other matters as may be necessary or expedient to enable the said Laboratory to carry out its functions;

(f) The matters necessary to be prescribed for the purposes of the proviso to sub-section (1).

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rut17, United Arab Emirates

What are the regulations for compounding hormones for BHRT therapies in India. Is this legal? what regulations do compounding pharmacies in India follow?

bubai_123, India

can a man selling homeopathy medicine as retailer without valid license? If so, what is punishment for that offence

rihdh.ray

Hi, I would like to know what is the punishment of illegally running a stem cell banking in India. there are companies running stem cell banking without license, also using and promoting technologies to customer which has no approval.

san15, India

Please confirm whether the drug is in JP and not in IP , is it mandatory to claim JP?

mtcgases, India

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.

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