Centre bans 14 FDC drugs: The Union government on Friday banned 14 fixed-dose combination (FDC) medicines after they were found to lack therapeutic relevance.
Fixed-dose combinations (FDCs), also referred to as “cocktail” drugs, are medicines that combine more than one drug in a single pill.
According to the notification, the Expert Committee recommended that “there is no therapeutic justification for this FDC and the FDC may involve risk to human beings”.
The notification also said that “in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution” of these FDCs.
Used for common ailments
The banned drugs are used for treating cough, common infections, fever and body ache and combinations such as Nimesulide + Paracetamol dispersible tablets, Amoxicillin + Bromhexine and Pholcodine +Promethazine.
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 behest of the Supreme Court, declared them as “irrational” and found that they were marketed to patients without scientific data proving their efficacy and safety.
The long-pending move has been taken on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board.
In public interest
“…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,” notification said.
But these drugs have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market. There are also fears that this may increase drug resistance in people.
Apart from banning cocktail medicines, the DCGI may also focus on banning codeine-based medicines in a phased manner.
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