India bans 14 fixed-dose medicines for likely posing risks to health

The government on Friday banned 14 fixed-dose combination (FDC) medicines as they have been found to lack therapeutic justification and have been recommended to be banned by an expert panel.

A FDC contains two or more active ingredients in a fixed dose ratio.

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”.