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The Drugs Act, 1940

( ACT NO. XXIII Of 1940 )

Chapter IV

MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS

Power of Government to make rules
 
 
 
 
33. (1) The Government may, after previous publication by notification in the official Gazette, make rules for the purpose of giving effect to the provisions of this Chapter.
 
 
(2) Without prejudice to the generality of the foregoing power, such rules may
 
 
 
 
(a) provide for the establishment of laboratories for testing and analysing 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 a drug is of standard quality;
 
 
 
 
(d) prescribe in respect of biological and organo metallic compounds, the units or methods of standardisation;
 
 
 
 
(e) prescribe the forms of licences for the manufacture for sale, for the sale and for the distribution of drugs or any specified drug or class of 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 therefore;
 
 
 
 
(f) specify the diseases or ailments which a drug may not purport or claim to cure or mitigate and such other effects which a drug may not purport or claim to have;
 
 
 
 
(g) prescribe the conditions subject to which small quantities of drugs may be manufactured for the purpose of examination, test or analysis;
 
 
 
 
(h) require the date of manufacture and the date of expiry of potency to be clearly and truly stated on the label or container of any specified drug or class of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of the said drug or class of drugs after the expiry of a specified period from the date of manufacture or after the expiry of the date of potency;
 
 
 
 
(i) prescribe the conditions to be observed in the packing in bottles, packages and other containers of drugs, and prohibit the sale, stocking or exhibition for sale, or distribution of drugs packed in contravention of such conditions;
 
 
 
 
(j) regulate the mode of labelling packed drugs, and prescribe the matters which shall or shall not be included in such labels;
 
 
(k) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any drug, prohibit the manufacture, sale or stocking or exhibition for sale, or distribution of any drug in which that proportion is exceeded, and specify substances which shall be deemed to be poisonous for the purposes of this Chapter and the rules made thereunder;
 
 
 
 
(l) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any patent or proprietary medicine containing such drug;
 
 
 
 
(m) prescribe the form of warranty referred to in sub section (1) of section 19;
 
 
 
 
(n) regulate the powers and duties of Inspectors;
 
 
 
 
(o) prescribe the forms of report to be given by Government Analysts, and the manner of application for test or analysis under section 26 and the fees payable therefore;
 
 
 
 
(p) specify the offences against this Chapter or any rule made thereunder in relation to which the stock of the drug shall be liable to confiscation under section 31;
 
 
 
 
(q) provide for the exemption, conditionally or otherwise, from all or any of the provisions of this Chapter or the rules made thereunder, of any specified drug or class of drugs.

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Ministry of Law, Justice and Parliamentary Affairs