Government bans 14 fixed dose combination drugs as they may pose 'risk' to people

There is "no therapeutic justification" for 14 fixed dose combination medications, including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup, which the government has banned on the grounds that they may pose a "risk" to individuals.

The Union Health Ministry gave a warning on Friday.

The drugs which are banned included those used for treating common infections, cough and fever - Combinations such as Nimesulide and Paracetamol dispersible tablets, Chlopheniramine Maleate and Codeine Syrup, Pholcodine and Promethazine, Amoxicillin and Bromhexine and Bromhexine and Dextromethorphan and Ammonium Chloride and Menthol, Paracetamol and Bromhexine and Phenylephrine and Chlorpheniramine and Chlorpheniramine and Salbutamol + Bromhexine.

An expert committee's recommendations prompted the move.

The expert committee said that there is "no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to human beings.

Hence,



in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable."

"And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country," the notification stated.

Drugs that combine two or more active pharmaceutical ingredients (APIs) in a fixed ratio are known as FDC drugs.

After an expert panel established at the request of the Supreme Court stated that 344 drug combinations were being sold to patients without scientific data, the government announced a ban on their manufacture, sale, and distribution in 2016. The order was challenged in court by the manufacturers.