Section 33. 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, among other matters: provide for the establishment of laboratories for testing and analysing drugs or cosmetics; prescribe qualifications and duties of Government Analysts and qualifications of Inspectors; prescribe methods of test or analysis for standard quality; prescribe standardisation units for biological and organometallic compounds; prescribe colours a drug or cosmetic may bear for colouring purposes; prescribe forms and conditions of manufacturing, sale and distribution licences and provide for their cancellation or suspension; prescribe records, registers and documents to be kept under section 18B; prescribe fees for inspection of premises for licensing purposes; prescribe the manner of certifying copies under section 22(2A); specify diseases or ailments a drug may not purport to cure or mitigate; prescribe conditions for manufacture of small quantities for examination, test or analysis; require dates of manufacture and expiry to be stated on labels and prohibit sale after expiry; prescribe packing conditions including packing material in direct contact with drugs; regulate labelling of packed drugs or cosmetics; prescribe the maximum proportion of poisonous substances permissible; require display of the accepted scientific name of a specified drug on patent or proprietary medicine labels; prescribe powers and duties of Inspectors and their subordination; prescribe forms of Government Analysts’ reports and fees for test or analysis under section 26; specify offences in relation to which confiscation orders may be made under section 31; provide for exemptions from provisions of this Chapter or rules made thereunder; and specify the sum which may be prescribed by the Central Government under section 32B.
Source: The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), Chapter IV, as amended by Act 26 of 2008.
