New Delhi: The government 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 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.
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