Govt bans 14 fixed-dose combination drugs used to treat cough, fever

The Union Health Ministry has banned 14 irrational fixed-dose combination (FDC) medicines five years after the Supreme Court told the government to examine the health benefits of these drugs.

In a series of notifications published on Friday, the ministry prohibited the manufacture, sale or distribution of 14 medicines for human use after an expert committee recommended that "there is no therapeutic justification for these FDCs and they may involve risk to human beings". The ban will come into immediate effect.

The banned drugs included those used for treating common infections, cough and fever, PTI reported. These include combinations such as Nimesulide + Paracetamol dispersible tablet, and Amoxicillin + Bromhexine.

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While FDCs — cocktails of two or more types of drugs — are meant to improve patient compliance, irrational FDCs remained a menace for the Indian market with drug-makers aggressively selling many such drugs.

The problematic use of FDCs was also flagged by a parliamentary standing committee a decade ago, resulting in the ban of nearly 350 medicines.

Adjudicating on the litigation in 2017, the Supreme Court exempted 15 medicines outside the scope of the government-imposed ban on procedural grounds but left it to the Centre to carry out an inquiry to decide whether the same prohibition can be extended to them.

An expert panel examined the cases of each of these 15 medicines and submitted its report recommending the ban to the ministry in April last year. Subsequently, the Drug Technical Advisory Board agreed to the recommendations.

Three of the 15 medicines exempted by the SC are not among the ones that have been banned. Instead, there are two additional ones.

The committee recommended that since there was no therapeutic justification for any of these FDCs and they may pose a risk to human beings, in the larger public interest, their manufacture and sale must be prohibited under Section 26A of the Drugs and Cosmetics Act, 1940, that provides such an option.

"These FDCs are irrational and unscientific, the expert committees have said clearly. Most of the affected manufacturers were not able to prove the therapeutic rationale, safety and efficacy of their FDCs. It shows that our regulators can undo wrong decisions of the past if they put their heart to it," All India Drug Action Network, which campaigned against irrational FDCs, said in a statement.

The following are the list of the 14 banned FDCs

1. Nimesulide, paracetamol dispersible tablet

2. Amoxicillin, bromhexine

3. Pholcodine, promethazine

4. Chlorpheniramine maleate, dextromethorphan, guaiphenesin, ammonium chloride, menthol

5. Ammonium chloride, bromhexine, dextromethorphan

6. Chlorpheniramine maleate, codeine syrup

7. Bromhexine, dextromethorphan, ammonium chloride, menthol

8. Dextromethorphan, chlorpheniramine maleate, guaiphenesin, ammonium chloride

9. Paracetamol, bromhexine, phenylephrine, chlorpheniramine, guaiphenesin

10. Salbutamol, bromhexine

11. Chlorpheniramine, codeine phosphate, menthol syrup

12. Phenytoin, phenobarbitone sodium

13. Ammonium chloride, sodium citrate, chlorpheniramine maleate, menthol syrup

14. Salbutamol, hydroxyethyl theophylline, bromhexine