Fourteen fixed-dose combination (FDC) medicines found to lack therapeutic relevance have been banned by the Central Government through a gazette notification issued over the weekend.
While industry experts claim that some of these combinations aren’t available in the market currently, the banned combinations include medicines used for cough, fever and infections, and are sold over the counter.
According to the Central Drugs Standard Control Organisation (CDSCO), FDCs refer to products containing one or more active ingredients used for a particular indication(s).
The ban, which comes into effect immediately, follows recommendations of an expert committee formed to examine the efficacy of these drug combinations.
The notification states that an expert committee recommended that “there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings”.
The notification also said that “in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution” of these FDCs.
The long-pending move has been taken based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board.
“The Central Government is satisfied that it is necessary and expedient in the 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,” the notification said.
The banned FDCs are part of 344 fixed-dose combinations prohibited for sale by the Union Health Ministry in 2016 but the makers of 15 such drugs challenged the decision in Delhi High Court.
Prohibited FDC medicines
- Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
- 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 5 ml
- Phenytoin + Phenobarbitone Sodium
- Chlorpheniramine + Codeine Phosphate + Menthol Syrup
- Salbutamol + Bromhexine
- Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
- Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
- Nimesulide + Paracetamol dispersible tablets
- Amoxicillin + Bromhexine
- Pholcodine + Promethazine
- Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
- Chlorpheniramine Maleate + Codeine Syrup
- Ammonium Chloride + Bromhexine + Dextromethorphan
- Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol