India bans 14 fixed-dose medicines for risks to health

NEW DELHI: The 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.

The FDCs mix two or more active ingredients in a fixed ratio. They 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. According to the government notification, the Expert Committee recommended that “there is no therapeutic justification” for these FDC and they may involve “risk” to human beings.

“Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940,” the notification said. It stated that any kind of regulation or restriction to allow for any use in patients is not “justifiable”. “Therefore, only prohibition under Section 26A is recommended,” it further said.

The FDCs are Nimesulide+ Paracetamol dispersible tablets, Amoxicillin+ Bromhexine, Pholcodine+ Promethazine, Chlorpheniramine maleate + Dextromethorphan + Guaiphenesin +Ammonium Chloride + Menthol, Chlopheniramine Maleate + Codeine Syrup, Ammomium Chloride + Bromhexine + Dextromethorphan, Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol, Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride, Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine +Guaiphenesin, Salbutamol + Bromhexine, Chlorpheniramine + Codeine Phosphate + Menthol Syrup, Phenytoin + Phenobarbitone sodium, Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg + 55mg + 4mg + 1mg) , (110mg + 46mg + 3mg + 0.9mg) & (130mg + 55mg + 3mg + 0.5mg) per 5ml syrup, Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine.

Earlier the government had restricted about 344 categories of FDCs. However, it was challenged by various manufacturers in the court. The Supreme Court had earlier asked the country’s top technical body-DTAB to review whether these drugs should continue to be sold.

The government said that the decision to ban the FDCs was taken following the recommendations of the Expert Committee and the Drugs Technical Advisory Board.

”The Central Government is satisfied that it is necessary and expedient in 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”.