Section 33N. 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 Ayurvedic, Siddha or Unani drugs; prescribe qualifications and duties of Government Analysts and qualifications of Inspectors; prescribe methods of test or analysis to determine whether a drug is labelled with the true list of ingredients it purports to contain; specify any substance as poisonous; prescribe forms of manufacturing and sale licences, application forms, conditions, authority and fees, and provide for cancellation or suspension of such licences; prescribe packing conditions including packing material in direct contact with drugs, regulate labelling and prescribe matters to be included or excluded from labels; prescribe conditions for manufacture of small quantities for examination, test or analysis; prescribe colours a drug may bear for colouring purposes; prescribe standards for Ayurvedic, Siddha or Unani drugs under section 33EB; prescribe records, registers or documents to be kept under section 33KB; and any other matter to be or which may be prescribed under this Chapter.
Source: The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), Chapter IVA, as amended by Act 26 of 2008.
