Last Updated on January 13, 2024 by The Health Master
14 FDC Drugs banned
The Indian government has taken a decisive step to ban 14 fixed-dose combination (FDC) drugs, including popular medications such as Nimesulide and Paracetamol dispersible tablets, as well as Chlopheniramine Maleate and Codeine syrup.
The Union Health Ministry issued a notification on Friday, stating that these medications lack therapeutic justification and may pose risks to individuals.
This move follows the recommendations made by an expert committee in the interest of public safety.
Reasons for the Ban:
The expert committee has conducted a thorough evaluation of these FDC drugs and has concluded that they do not possess any therapeutic justification.
Additionally, they have determined that these combinations may potentially endanger human health.
Consequently, the Union Health Ministry has deemed it necessary to prohibit the manufacture, sale, and distribution of these FDC drugs under section 26A of the Drugs and Cosmetics Act, 1940.
The notification highlights that any regulatory measures allowing the use of these drugs in patients would not be justifiable.
Banned Drug Combinations:
The 14 FDC drugs that have been banned encompass a range of treatments for common infections, cough, and fever.
They include:
- 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 + hydroxy ethyl theophylline + bromhexine
FDC Drugs Defined:
Fixed-dose combination (FDC) drugs consist of two or more active pharmaceutical ingredients (APIs) combined in a fixed ratio.
They are formulated to provide synergistic therapeutic effects. However, in the case of these banned drugs, the expert committee has determined that their combinations lack therapeutic justification and may pose risks to individuals.
Background and Precedent:
In 2016, the Indian government had previously imposed a ban on the manufacture, sale, and distribution of 344 drug combinations.
This action came after an expert panel, established at the request of the Supreme Court, concluded that these combinations were being marketed to patients without proper scientific data.
The manufacturers challenged the ban in court. The recently banned 14 FDC drugs are among the 344 combinations targeted in the previous ban.
Conclusion:
The Indian government’s decision to prohibit the manufacture, sale, and distribution of these 14 fixed-dose combination drugs stems from concerns over their therapeutic justification and potential risks to human health.
By acting on the recommendations of an expert committee, the government aims to prioritize public safety and ensure that medications available in the country adhere to necessary standards.
S.O 2405(E) dt 02-06-2023 Banned under section 26A FDC Phenytoin + Phenobarbitone sodium
S.O 2403(E) dt 02-06-2023 Banned under section 26A FDC Salbutamol + Bromhexine
S.O 2398(E) dt 02-06-2023 Banned under section 26A FDC Chlopheniramine Maleate + Codeine Syrup
S.O 2396(E) dt 02-06-2023 Banned under section 26A FDC Pholcodine+ Promethazine
S.O 2395(E) dt 02-06-2023 Banned under section 26A FDC Amoxicillin+ Bromhexine
S.O 2394(E) dt 02-06-2023 Banned under section 26A FDC Nimesulide+ Paracetamol dispersible tablets
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