Section 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 cover, among other matters: specifying drugs or cosmetics for which an import licence is required and the conditions, fees and cancellation/suspension of such licences; prescribing methods of test or analysis to determine standard quality; prescribing units or methods of standardisation for biological and organometallic compounds; prescribing colours a drug may bear for colouring purposes; specifying diseases or ailments an imported drug may not purport to cure or mitigate; prescribing conditions for import of small quantities for examination, test, analysis or personal use; prescribing places at which drugs or cosmetics may be imported; requiring dates of manufacture and expiry to be stated on labels of imported drugs and prohibiting import after expiry; regulating submission and securing of samples for the Central Drugs Laboratory and fees payable; prescribing evidence of quality to be supplied by importers and procedure of Customs officers; providing exemptions for drugs or cosmetics imported for transport through or export from India; prescribing packing conditions including packing material in direct contact with drugs; regulating labelling of imported drugs or cosmetics; prescribing the maximum proportion of poisonous substances permissible and specifying substances deemed poisonous; requiring the accepted scientific name of a specified drug to be displayed on labels of patent or proprietary medicines; and providing for exemptions, conditional or otherwise, from provisions of this Chapter or rules made thereunder.
Source: The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), Chapter III.
