AMN / WEB DESK
The Government of India on Friday banned 14 types of fixed-dose combination (FDC) medicines due to a lack of therapeutic justification and potential risks to humans. It was done after 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.
A FDC contains two or more active ingredients in a fixed dose ratio.
As per the notification, the expert recommended that there is no medical justification for the use of these FDC and they may involve risk to humans.
It has also been said in the notification that it is necessary to ban the manufacture, sale or distribution of these FDCs in the larger public interest.
This long-pending step has been taken on the basis of the recommendations of the Expert Committee and the Drug Technical Advisory Board.
In 2016, the ministry launched a drive to filter out drug combinations from the Indian pharmaceutical industry by banning around 350 FDCs, affecting over 2,700 branded drugs.
Apart from banning cocktail drugs, DCGI may also focus on banning codeine-based drugs in a phased manner.
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