Drugs and Cosmetics Act, 1940 - Chapter not to apply to [Ayurvedic, Siddha or Unani] drugs

33A. Chapter not to apply to [Ayurvedic, Siddha or Unani] drugs. – Save as otherwise provided in this Act, nothing contained in this Chapter shall apply to [Ayurvedic, Siddha or Unani] drugs.]

33B. Application of Chapter IVA. – This Chapter shall apply only to [(Note: Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 1-2-1983)) Ayurvedic, Siddha and Unani] drugs.

33C. Ayurvedic and Unani Drugs Technical Advisory Board. – (1) The Central Government shall, by notification in the Official Gazette and with effect from such date as may be specified therein, constitute a Board (to be called the [(Note: Subs. by Act 68 of 1982, sec.30, for certain words (w.e.f. 1-2-1983)) Ayurvedic, Siddha and Unani Drugs Technical Advisory Board] to advise the Central Government and the State Governments on technical matters arising out of this Chapter and to carry out the other functions assigned to it by this Chapter.

(2) The Board shall consist of the following members, namely, -

(i) The Director General of Health Services, ex officio ;

(ii) The Drugs Controller, India, ex officio,

[(iii) (Note: Subs. by Act 68 of 1982, sec.30, for clause (iii) (w.e.f. 1-2-1983)) The principal officer dealing with Indian systems of medicine in the Ministry of Health, ex-officio;]

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

(v) One person holding the appointment of Government Analyst under section 33F, to be nominated by the Central Government ;

(vi) One Pharmacognocist to be nominated by the Central Government ;

(vii) One Photo-chemist to be nominated by the Central Government ;

[(viii) (Note: Subs. by Act 68 of 1982, sec.30 for clause (viii) (w.e.f. 1-2-1983)) Four persons to be nominated by the Central Government, two from amongst the members of the Ayurvedic Pharmacopoeia Committee, one from amongst the members of Unani Pharmacopoeia Committee and one from amongst the members of the Siddha Pharmacopoeia Committee ;]

(ix) One teacher in Darvyaguna, and Bhaishajya Kalpana, to be nominated by the Central Government ;

(x) One teacher in ILM-UL-ADVIA and TAKLIS-WA-DAWASAZI, to be nominated by the Central Government ;

[(xi) (Note: Subs. by Act 68 of 1982, sec.30, for clauses (xi) and (xii) (w.e.f. 1-2-1983)) One teacher in Gunapadam to be nominated by the Central Government ;

(xii) Three persons, one each to represent the Ayurvedic, Siddha and Unani drug industry, to be nominated by the Central Government ;

(xiii) Three persons, one each from amongst the practitioners of Ayurvedic, Siddha and Unani Tibb systems of medicine to be nominated by the Central Government.]

(3) The Central Government shall appoint a member of the Board as its Chairman.

(4) The nominated members of the Board shall hold office for three years but shall be eligible for recombination.

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

(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.

33D. The Ayurvedic, Siddha and Unani Drugs Consultative Committee. – (1) The Central Government may constitute an Advisory Committee to be called the Ayurvedic, Siddha and Unani Drugs Consultative Committee to advise the Central Government, the State Governments and the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board on any matter for the purpose of securing uniformity throughout India in the administration of this Act in so far as it relates to Ayurvedic, Siddha or Unani drugs.

(2) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall consist of two persons to be nominated by the Central Government as representatives of that Government and not more than one representative of each State to be nominated by the State Government concerned.

(3) The Ayurvedic, Siddha and Unani Drugs Consultative Committee shall meet when required to do so by the Central Government and shall regulate its own procedure.

33E. Misbranded drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be misbranded –

(a) If it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is ; or

(b) If it is not labeled in the prescribed manner ; or

(c) If its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.

33EE. Adulterated drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be adulterated, -

(a) If it consists, in whole or in part, of any filthy, putrid or decomposed substance ; or

(b) It has been prepared, packed or stored under in sanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health ; or

(c) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health ; or

(d) If it bears or contains, for purposes of colouring only, a colour other than one which is prescribed ; or

(e) If it contains any harmful or toxic substance which may render it injurious to health ; or

(f) If any substance has been mixed therewith so as to reduce its quality or strength.

Explanation. – For the purpose of clause (a), a drug shall not be deemed to consist, in whole or in part, of any decomposed substance only by reason of the fact that such decomposed substance is the result of any natural decomposition of the drug :

Provided that such decomposition is not due to any negligence on the part of the manufacturer of the drug or the dealer thereof and that it does not render the drug injurious to health.

33EEA. Spurious drugs. – For the purposes of this Chapter, an Ayurvedic, Siddha or Unani drug shall be deemed to be spurious –

(a) If it is sold, or offered or exhibited for sale, under a name which belongs to another drug ; or

(b) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive, or bears upon it or upon its label or container the name of another drug, unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug ; or

(c) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist ; or

(d) If it has been substituted wholly or in part by any other drug or substance ; or

(e) If it purports to be the product of a manufacturer of whom it is not truly a product.

33EEB. Regulation of manufacturer for sale of Ayurvedic, Siddha and Unani drugs. – No person shall manufacture for sale or for distribution any Ayurvedic, Siddha or Unani drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.

33EEC. Prohibition of manufacture and sale of certain Ahyurvedic, Siddha and Unani drugs. – From such date as the State Government may, by notification in the Official Gazette, specify in this behalf, no person, either by himself or by any other person on his behalf, shall –

(a) Manufacture for sale or for distribution -

(i) Any misbranded, adulterated or Ayurvedic, siddha or Unani drug ;

(ii) Any patent or proprietary medicine, unless there is displayed in the prescribed manner on the label or container thereof the true list of all the ingredients contained in it ; and

(iii) Any Ayurvedic, Siddha or Unani drug in contravention of any of the provisions of this Chapter or any rule made thereunder ;

(b) Sell, stock or exhibit or offer for sale or offer for sale or distribute any Ayurvedic, Siddha or Unani drug which has been manufactured in contravention of any of the provisions of this Act, or any rule made thereunder :

(c) Manufacture for sale or for distribution, any Ahyurvedic, Siddha or Unani drug, except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter by the prescribed authority.

Provided that nothing in this section shall apply to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drug for the use of their own patients :

Provided further that nothing in this section shall apply to the manufacture, subject to the prescribed conditions, of small quantities of any Ayurvedic, Siddha or Unani drug for the purpose of examination, test or analysis.

33EED. Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest. – Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied on the basis of any evidence or other material available before it that the use of any Ahyurvedic, Siddha or Unani drug is likely to involve any risk to human beings or animals or that any such drug does not have the therapeutic value claimed or purported to be claimed for it and that in the public interest it is necessary or expedient so to do then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug.]