Nimesulide + Paracetamol among 14 fixed dose combination drugs now banned

The rationale behind this action is the absence of "therapeutic justification" for these medications and the potential "risk" they pose to individuals.

The government has taken the decision to prohibit the use of 14 fixed-dose combinations (FDC) drugs, including Nimesulide and Paracetamol dispersible tablets, and Chlorpheniramine Maleate and Codeine syrup. The rationale behind this action is the absence of "therapeutic justification" for these medications and the potential "risk" they pose to individuals.

The Union Health Ministry issued an official notification on Friday to enforce this ban. The prohibited drugs encompassed various combinations utilized for the treatment of common infections, cough, and fever. These include Nimesulide + Paracetamol dispersible tablets, Chlorpheniramine Maleate + Codeine Syrup, Pholcodine + Promethazine, Amoxicillin + Bromhexine, Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol, Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaiphenesin, and Salbutamol + Bromhexine.

This decision was made based on the recommendations put forth by an expert committee. The committee concluded that there is no valid therapeutic justification for the fixed-dose combination drugs and that they may pose risks to human health. In the interest of public welfare, the manufacture, sale, and distribution of these FDC drugs are deemed necessary to be prohibited under section 26 A of the Drugs and Cosmetics Act, of 1940. The notification emphasized that any form of regulation or restriction allowing their use in patients is unjustifiable.

The notification further stated, "Based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient, in the interest of public welfare, to regulate and prohibit the manufacture, sale, and distribution of these drugs for human use within the country."

Fixed-dose combination drugs are formulations that contain a combination of two or more active pharmaceutical ingredients (APIs) in fixed ratios. In 2016, the government had already imposed a ban on 344 drug combinations after an expert panel, established by the Supreme Court, found that they were being marketed to patients without sufficient scientific data. The manufacturers had challenged the order in court. The currently banned 14 FDCs are included in the list of those 344 drug combinations.