In a move aimed at safeguarding public health, the government has announced the prohibition of 14 fixed-dose combination (FDC) medicines. These FDCs, which consist of two or more active ingredients in a fixed ratio, have been found to lack therapeutic justification and pose potential risks to human beings. This decision was made based on the recommendations put forth by an expert panel.
According to the official notification issued by the government, the expert committee concluded that there is no valid therapeutic reason to support the use of these FDCs. Furthermore, they identified potential risks associated with their consumption. In light of these findings and with the larger public interest in mind, the government has invoked Section 26A of the Drugs and Cosmetics Act, 1940, to ban the manufacturing, sale, and distribution of these FDCs.
The notification emphasizes that any form of regulation or restriction allowing the use of these FDCs in patients is not justifiable. Hence, the expert committee has recommended the complete prohibition of these FDCs through Section 26A.
The 14 banned FDCs include:
1. Nimesulide + Paracetamol dispersible tablets
2. Amoxicillin + Bromhexine
3. Pholcodine + Promethazine
4. Chlorpheniramine maleate + Dextromethorphan + Guaiphenesin + Ammonium Chloride + Menthol
5. Chlopheniramine Maleate + Codeine Syrup
6. Ammomium Chloride + Bromhexine + Dextromethorphan
7. Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
8. Dextromethorphan + Chlorpheniramine + 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 (100mg + 40mg + 2.5mg + 0.9mg)
14. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (125mg + 55mg + 4mg + 1mg)
15. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (110mg + 46mg + 3mg + 0.9mg)
16. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol (130mg + 55mg + 3mg + 0.5mg)
17. Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
Prior to this ban, the government had already imposed restrictions on 344 categories of FDCs. However, these restrictions were challenged in court by various manufacturers. In response, the Supreme Court sought the review of these drugs by the Drugs Technical Advisory Board (DTAB), the country’s top technical body.
The government has based its decision to ban these FDCs on the recommendations provided by the Expert Committee and the DTAB. It believes that prohibiting the manufacture, sale, and distribution of these drugs is necessary and expedient in the interest of public health. This step underscores the government’s commitment to regulating pharmaceutical products and ensuring the well-being of its citizens