The federal Department of Health has banned 14 unreasonable fixed-dose combination drug (FDC) drugs, five years after the Supreme Court ordered the government to investigate the health benefits of those drugs.
In a series of notices released on Friday, the department responded after an expert panel recommended that “these FDCs have no therapeutic justification and may pose a risk to humans.” , banned the manufacture, sale and distribution of 14 drugs for human use. The ban is effective immediately.
Banned substances included drugs used to treat common infections, coughs, and fevers. PTI report. These include combinations such as nimesulide + paracetamol dispersible tablets, amoxicillin + bromhexine.
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FDCs (mixtures of two or more drugs) aim to improve patient compliance, but unreasonable FDCs are still on the Indian market as pharmaceutical companies aggressively market large numbers of such drugs. poses a threat to
The problematic use of FDCs was flagged by a standing committee of Congress a decade ago, resulting in the banning of about 350 drugs.
In a ruling in a 2017 case, the Supreme Court exempted 15 drugs outside the government-imposed ban for procedural reasons, but the Center is investigating whether a similar ban could apply to these drugs. entrusted to
An expert panel reviewed cases for each of these 15 drugs and submitted a report to the ministry last April recommending a ban. The Pharmaceutical Technology Advisory Board subsequently agreed with this recommendation.
Three of the 15 drugs exempted by the SC are not among the banned drugs. Instead, there are two more.
Because these FDCs had no therapeutic justification and could pose a hazard to humans, the Commission decided that, in the greater public interest, under section 26A of the Pharmaceuticals and Cosmetics Act of 1940, He recommended that the manufacture and sale of the product should be prohibited. provide such an option.
“These FDCs are irrational and unscientific,” the panel of experts unequivocally states. This shows that if our regulators make a decision, they can undo past wrong decisions. The All India Counter-Drug Network, which is campaigning to do so, said in a statement.
Below is a list of the 14 prohibited FDCs.
1. Nimesulide, paracetamol dispersible tablets
2. Amoxicillin, bromhexine
3. Horcodin, promethazine
4. Chlorpheniramine Maleate, Dextromethorphan, Guaifenesin, Ammonium Chloride, Menthol
5. Ammonium chloride, bromhexine, dextromethorphan
6. Chlorpheniramine Maleate, Codeine Syrup
7. Bromhexine, Dextromethorphan, Ammonium Chloride, Menthol
8. Dextromethorphan, Chlorpheniramine Maleate, Guaifenesin, Ammonium Chloride
9. Paracetamol, bromhexine, phenylephrine, chlorpheniramine, guaifenesin
10. Salbutamol, bromhexine
11. Chlorpheniramine, Codeine Phosphate, Menthol Syrup
12. Phenytoin, Phenobarbitone Sodium
13. Ammonium chloride, sodium citrate, chlorpheniramine maleate, menthol syrup
14. Salbutamol, Hydroxyethyltheophylline, Bromhexine
