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Section 33N – The Drugs and Cosmetics Act, 1940

The Drugs and Cosmetics Act, 1940



33N. Power of Central Government to make rules. –


(1) The Central Government may, 1[after consultation with, or on the recommendation of, the Board] and after previous publication by notification in the Official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter:


Provided that consultation with the Board may be dispensed with if the Central Government is of opinion that circumstances have arisen which render it necessary to make rules without such consultation, but in such a case, the Board shall be consulted within six months of the making of the rules and the Central Government shall take into consideration any suggestions which the Board may make in relation to the amendment of the said rules.


(2) Without prejudice to the generality of the foregoing power, such rules may—


(a) provide for the establishment of laboratories for testing and analysing 2[Ayurvedic, Siddha or Unani] drugs;


(b) prescribe the qualifications and duties of Government Analysts and the qualifications of Inspectors;


(c) prescribe the methods of test or analysis to be employed in determining whether any 2[Ayurvedic, Siddha or Unani] drug is labelled with the true list of the ingredients which it is purported to contain;


(d) specify any substance as a poisonous substance;


(e) prescribe the forms of licences for the manufacture for sale of 2[Ayurvedic, Siddha or Unani] drugs, 3[and for sale of processed Ayurvedic, Siddha or Unani drugs,] the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same and the fees payable therefor; 3[and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with];


4[(f) prescribe the conditions to be observed in the packing of Ayurvedic, Siddha and Unani drugs including the use of packing material which comes into direct contact with the drugs, regulate the mode of labelling packed drugs and prescribe the matters which shall or shall not be included in such labels;]


(g) prescribe the conditions subject to which small quantities of 5[Ayurvedic, Siddha or Unani] drugs may be manufactured for the purpose of examination, test or analysis; and


6[(gg) prescribe under clause (d) of section 33EE the colour or colours which an Ayurvedic, Siddha or Unani drug may bear or contain for purposes of colouring;


(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs under section 33EEB;]


(h) any other matter which is to be or may be prescribed under this Chapter.



1. Subs. by Act 68 of 1982, sec. 35, for “after consultation with the Board” (w.e.f. 1-2-1983).


2. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).


3. Ins. by Act 68 of 1982, sec. 35 (w.e.f. 1-2-1983).


4. Subs. by Act 68 of 1982, sec. 35, for “clause (f)” (w.e.f. 1-2-1983).


5. Subs. by Act 68 of 1982, sec. 2, for “Ayurvedic (including Siddha) or Unani” (w.e.f. 1-2-1983).


6. Ins. by Act 68 of 1982, sec. 35 (w.e.f. 1-2-1983).



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The Drugs and Cosmetics Act, 1940


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