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12. Power of Central Government to make rules.- (1) The Central Government may, 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) specify the drugs or classes of drugs or cosmetics or classes of cosmetics for the import of which a licence is required, and prescribe the form and conditions of such licences, the authority empowered to issue the same, the fees payable therefor and provide f or the cancellation, or suspension of such licence in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which the licence is issued is not complied with;

(b) prescribe the methods of test or analysis to be employed in determining whether a drug or cosmetic is of standard quality;

(c) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation;

(cc) prescribe under clause (d) of section 9A the colour or colours which a drug may bear or contain for purposes of colouring;

(d) specify the diseases or ailments which an imported drug may not purport or claim to prevent, cure or mitigate and such other effects which such drug may not purport or claim to have;

(e) prescribe the conditions subject to which small quantities of drugs, the import of which is otherwise prohibited under this Chapter, may, be imported for the purpose of examination, test or analysis or for personal use;

(f) prescribe the places at which drugs or cosmetics may be imported, and prohibit their import at any other place;

(g) 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 imported drug or class of such drug, and prohibit the import of the said drug or class of drug after the expiry of a specified period from the date of manufacture:

(h) regulate the submission by importers, and the securing, of samples of drugs or cosmetics for examination, test or analysis by the Central Drugs Laboratory, and prescribe the fees, if any, payable for such examination, test or analysis.,

(i) prescribe the evidence to be supplied, whether by accompanying documents or otherwise, of the quality of drugs or cosmetics sought to be imported, the procedure of officers of Customs in dealing with such evidence, and the manner of storage at places of import of drugs or cosmetics detained pending admission;

(j) provide for the exemption,. conditionally or otherwise, from all or any of the provisions of this Chapter and the rules made thereunder of drugs or cosmetics imported for the purpose only of transport through, .and export from, 2India;

(k) prescribe the conditions to be observed in the packing in bottles, packages or other containers, of imported drugs or cosmetics including the use of packing material which comes into direct contact with the drugs.

(l) regulate the mode of labelling drugs or cosmetics imported for sale in packages, and prescribe the matters which shall or shall not be included in such labels;

(m) prescribe the maximum proportion of any poisonous substance which may be added to or contained in any imported drug, prohibit the import 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;

(n) require that the accepted scientific name of any specified drug shall be displayed in the prescribed manner on the label or wrapper of any imported, patent or proprietary medicine containing such drug;

(o) 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 or cosmetic or class of cosmetics.





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