Key Points
The government has banned 14 fixed-dose combination drugs including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup citing there is "no therapeutic justification" for these medicines and that they may involve "risk" to people..
The banned drugs included those used for treating common infections, cough and fever - combinations such as Nimesulide + Paracetamol dispersible tablets, Chlorpheniramine Maleate + Codeine Syrup, Pholcodine + Promethazine, Amoxicillin + Bromhexine and Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol, Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin and Salbutamol + Bromhexine...
And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country," the notification stated...
In 2016, the government announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court...
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Govt bans 14 fixed dose combination drugs, cites they may involve risk to people
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India bans 14 fixed-dose medicines for likely posing risks to health
03, Jun, 23The Indian government has banned 14 types of fixed-dose combination (FDC) medicines due to a lack of therapeutic justification and potential risks to humans, according to an expert panel's recommendations. FDCs mix two or more active ingredients in a fixed ratio. The FDCs that have been banned include Nimesulide+ Paracetamol dispersible tablets and Pholcodine+ Promethazine, amongst others. The decision has been taken after an earlier restriction of 344 FDCs was challenged by manufacturers in court.
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