14 Fixed-Dose Drugs to Treat Cold, Cough Banned By Health Ministry: What We Know

The Union Health Ministry banned 14 fixed-dose drugs due to their lack of therapeutic justification.

Drug regulators must stop viewing incidents in the Gambia and Uzbekistan in isolation.

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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

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

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.