The Union Health Ministry banned 14 fixed dose combination (FDC) drugs citing lack of therapeutic justification and expert committee’s recommendation for their prohibition, published a gazette notification on Friday.
Drugs mentioned are used to treat common ailments
FDC drugs contain a combination of two or more active pharmaceutical ingredients in single form which is manufactured in a fixed ratio and then distributed. In the latest notification the drugs mentioned are used for treating cough, fever, common infections, body ache and combinations like Paracetamol dispersible tablets, Amoxicillin + Bromhexine and Pholcodine +Promethazine.
344 drug combinations banned in 2016
These FDCs were part of a group of 344 drug combinations that were banned in 2016 by the government after an expert panel, constituted at the order of the Supreme Court, declared them as “irrational”. It was also found that they were marketed to patients without scientific data proving their efficacy and safety.
Marketing License mandatory
Chinu Srinivasan, an activist who is associated with patients right group, filed a complain against the FDC’s in the Supreme Court. He further said that all the drugs in India before obtaining manufacturing license from State drug administration should have marketing approval from Central Drugs Standard Control Organization (CDCSO).
FDC’s without getting marketing license secured manufacturing approval
Mentioned FDC’s without getting a marketing license secured manufacturing approval from State drug administration. Most of the drugs out of the list of 344 drugs are banned except some which have contested the case saying that those were launched prior to 1988 when marketing approval by CDCSO came into force. After this the case reached Delhi High Court which ordered to form another committee to look into the matter. The second committee recommended the FDC in the latest notification.
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