The Union Health Ministry, in a notification issued on 2 June, banned 14 fixed-dose combination (FDC) medicines, citing lack therapeutic relevance.
In the gazette notification issued over the weekend, the Centre has banned combinations that include nimesulide and paracetamol dispersible tablets, and codeine-based cough syrups those drugs used for cough, fever and infections, among others.
“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 Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable”.Health Ministry Notification
The list of FDCs include cough syrups, anti-allergy drugs, and painkillers used mainly for the treatment of colds-coughs, and respiratory infections.
The Banned Combinations
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
What Are FDCs?
FDCs or fixed-dose drugs are those drugs that combine two or more drugs in a fixed ratio into a single dosage form, as described by in PubMed Central. It was further stated how FDCs are justified when they demonstrate clear benefits in terms of:
Potentiating therapeutic efficacy
Reducing the incidence of adverse effect of drugs
Having pharmacokinetic advantage
Better compliance by reducing the pill burden
Reducing dose of individual drugs
Decreasing development of resistance
Cheaper than individual drug
The banned FDCs were also included in 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.