Centre bans 14 fixed dose combination drugs used for treating common ailments citing health ‘risk’

The banned drugs included those used for treating infections like cough and fever; follows the recommendations of an expert committee.

The Central Government has banned fourteen different fixed-dose combination (FDC) medicines through a gazette this past weekend.  

This action follows the advice from an expert committee which said, “there is no therapeutic justification for this FDC and the FDC 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 26A of the Drugs and Cosmetic Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable.”

The FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio.

The list of banned drugs included a few drugs that are used to treat common infections. Fixed-dose combinations have two or more active pharmaceutical ingredients present in a fixed ratio. The list of 14 banned FDCs include – 

  • Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
  • Phenytoin + Phenobarbitone Sodium
  • Salbutamol + Bromhexine
  • Chlorpheniramine + Codeine Phosphate + Menthol Syrup
  • Nimesulide + Paracetamol dispersible tablets
  • Pholcodine + Promethazine
  • Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
  • Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
  • Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
  • Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
  • Amoxicillin + Bromhexine
  • Chlorpheniramine Maleate + Codeine Syrup
  • Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
  • Ammonium Chloride + Bromhexine + Dextromethorphan 

These banned FDCs are also the part of 344 FDCs previously prohibited for sale by the Health Ministry back in 2016. 

The notification also said, “The Central Government is convinced that this move is necessary and in the public’s best interest to keep a check on the sale and manufacturing for human use of the drug in the country.”

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