Guest guest Posted February 22, 2011 Report Share Posted February 22, 2011 Dear members, Drug control issues: Indian scenario FDC is rational or irrational needs an examination as per provisions made in Schedule-Y. The power of examination of an FDC as per Schedule-Y lies with the Licensing Authority notified under section 21( i.e. DCGI (India) . It is an accepted fact that an FDC be treated as a new drug, because by combining two or more drugs, the safety, efficacy, and bioavailability of the individual Active Pharmaceutical Ingredient (API) may change. As per the Drugs and Cosmetic Act, 1940, any new drug and the permission to market a drug is to be given by the DCGI. The Indian drug control authority has issued notifications banning many FDCs. The principal notification under Section 26-A of the Drugs and Cosmetics Act, 1940, (prohibiting manufacture, sale and distribution of certain FDCs, which do not have any therapeutic justification or are likely to involve risk to human being) banned around 79 drug formulations from the year 1983 till date. Some examples are FDCs of vitamins with anti-inflammatory agents and tranquillisers, of anti-histamines with anti-diarrhoeals etc. Regards, Dr.Sonali Pimpalkhute, Lecturer,Pharmacology, GMC,Nagpur. Quote Link to comment Share on other sites More sharing options...
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