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Union of India - Section

Section 31 in The Drugs and Cosmetics Rules, 1945

31. [ Standard for certain imported drugs. [Substituted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]

- No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the rules shall be applicable for determining whether any such imported drug complies with the said standards:Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(I) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent. residual shelf-life period as on the date of import:Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.]