New Delhi, June 03, 2023 - The Central Government has issued a gazette notification banning fourteen fixed-dose combination (FDC) medicines that lack therapeutic relevance. These combinations, which include medicines used for cough, fever, and infections and are sold over the counter, have been deemed unnecessary and potentially risky by an expert committee.
Although some of these banned combinations are currently unavailable in the market, the Central Drugs Standard Control Organisation (CDSCO) defines FDCs as products containing one or more active ingredients for specific indications.
The ban, effective immediately, is in line with the recommendations of the expert committee and the Drugs Technical Advisory Board. The notification states that these FDCs have no therapeutic justification and may pose risks to human beings. In the interest of public health, the manufacture, sale, and distribution of these FDCs have been prohibited.
These banned FDCs were initially part of the 344 fixed-dose combinations prohibited by the Union Health Ministry in 2016. However, the makers of fifteen drugs challenged the decision in the Delhi High Court.
Prohibited FDC Medicines:
1. Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
2. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (multiple variants)
3. Phenytoin + Phenobarbitone Sodium
4. Chlorpheniramine + Codeine Phosphate + Menthol Syrup
5. Salbutamol + Bromhexine
6. Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin
7. Dextromethorphan + Chlorpheniramine + Guaiphenesin + Ammonium Chloride
8. Nimesulide + Paracetamol dispersible tablets
9. Amoxicillin + Bromhexine
10. Pholcodine + Promethazine
11. Chlorpheniramine Maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
12. Chlorpheniramine Maleate + Codeine Syrup
13. Ammonium Chloride + Bromhexine + Dextromethorphan
14. Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
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