The Drugs and Cosmetics Act, 1940




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        It was obligatory on the part of the rule making authority to satisfy the Court that it was necessary in the facts and circumstances of  the case to enhance the fees payable for   the renewal of licence in the manner as has been sought to be done; M/s Jaiswal Medical Hall v. Union of India, AIR 1988 Pat 266.




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.]


(Note: Ins. by Act 13 of 1964, sec.26 (w.e.f. 1-2-1969))
(Note: Subs. by Act 68 of 1982, sec.2, for certain words (w.e.f. 01.02.1983))


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. 01.02.1983)) 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. 01.02.1983)) 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. 01.02.1983)) 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. 01.02.1983)) 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. 01.02.1983)) 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 renomination.
(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 – (Note: Subs. by Act 68 of 1982, sec.31, for sections 33D and 33E (w.e.f. 01.02.1983))


(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 insanitary 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.


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