Amendment status not verified — confirm the current text below against the official source.
Power of Central Government to make rules.—4[(1) The Central Government may 5[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) provide for the establishment of laboratories for testing and analysing drugs 6[or cosmetics]; (b) prescribed 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 6[or cosmetic] is of standard quality; (d) prescribe, in respect of biological and organometallic compounds, the units or methods of standardisation; 7[(dd) prescribe under clause (d) of 5[section 17A] the colour or colours which a drug may bear or contain for purposes of colouring;] (e) prescribe the forms of licences 8[for the manufacture for sale or for distribution], for the sale and for the distribution of drugs or any specified drug or class of drugs 6[or of cosmetics or any specified cosmetic or class of cosmetics], the form of application for such licences, the conditions subject to which such licences may be issued, the authority empowered to issue the same 8[, the qualification of such authority] and the fees payable therefor 8[and provide for the cancellation or suspension of such licences in any case where any provision of this Chapter or the rules made thereunder is contravened or any of the conditions subject to which they are issued is not complied with;] 8[(ee) prescribe the records, registers or other documents to be kept and maintained under section 18B; (eea) prescribe the fees for the inspection (for the purposes of grant or renewal of licence) of premises, wherein any drug or cosmetic is being or is proposed to be manufactured; (eeb) prescribe the manner in which copies are to be certified under sub-section (2A) of section 22;] (f) specify the diseases or ailments which a drug may not purport or claim 9[to prevent, 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; _________________________________________________________________________________________________