Fourteen popular drugs sold over the counter for common ailments such as cough, fever and infections have been banned in India.Known as Fixed Dose Combination (FDC) medicines, these have been found to lack therapeutic relevance. The Government announced the ban through a gazette notification issued over the weekend. The long-pending move has been taken based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board.The notification states that the Expert Committee had found that “there is no therapeutic justification for these FDCs and the FDCs may involve risk to human beings”. The ban, it said, was being imposed “in the larger public interest".
“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 Central Drugs Standard Control Organisation (CDSCO) defines FDCs as products containing one or more active ingredients used for a particular indication or multiple indicationss. 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 had, at the time, challenged the decision in the Delhi High Court.
The FDCs banned now are:
1. Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
2. 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
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