Five years after the Supreme Court asked the government to investigate the health benefits of these drugs, the Union Health Ministry has banned 14 irrational Fixed Dose Compound (FDC) drugs.
In a series of notices issued by the ministry on Friday, an expert committee banned the manufacture, sale and distribution of 14 medicines to humans after recommending that “there is no medical justification for these FDCs and they may pose a risk to humans.” The ban will take effect immediately.
Prohibited medicines for common infections, cough and fever; PTI He reported. These include combinations such as Nimesulide + Paracetamol dispersible tablets and Amoxicillin + Bromhexine.
Also read | Prescribing generic drugs or prescribing facial measures: Center speaks to doctors in central government hospitals
While FDCs – cocktails of two or more types of drugs – are intended to improve patient compliance, irrational FDCs remain a threat to the Indian market as drugmakers aggressively sell more such drugs.
The problematic use of FDCs was pointed out by a parliamentary standing committee a decade ago, which led to the banning of around 350 drugs.
In the year Ruling on the dispute in 2017, the Supreme Court exempted 15 drugs from the government’s ban on procedural grounds, but left it to the Center to conduct an inquiry to decide whether the same ban could be extended.
An expert team examined each case of these 15 drugs and submitted its report to the ministry recommending the ban in April last year. Subsequently, the Drug Technical Advisory Board accepted the recommendations.
Of the 15 SC exempted drugs, three are not found in the banned ones. Instead, there are two more.
The Committee urged that as there was no medical justification for these FDCs and they could pose a risk to human beings, in the larger public interest, their manufacture and sale should be banned under Section 26A of the Drugs and Cosmetics Act, 1940. It offers such an option.
“These FDCs are irrational and unscientific, the expert committee clearly stated. Most of the affected manufacturers failed to prove the medical rationality, safety and efficacy of FDCs. This shows that our regulators can overturn wrong decisions if they pass. Take heart,” said the campaigner against irrational FDCs. All India Drug Action Network said in a statement.
The following is a list of 14 prohibited FDCs.
1. Nimesulide, paracetamol dispersible tablet
2. Amoxicillin, bromhexine
3. Pholcodine, 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, hydroxyethyl theophylline, bromhexine
[ad_2]
Comments