India bans 14 fixed-dose combination drugs including nimesulide and paracetamol: Report

Gujarat, National, World

The Indian government has banned 14 fixed-dose combination drugs including nimesulide and paracetamol dispersible tablets and chlorpheniramine maleate and codeine syrup. Citing a notification from the Union Health Ministry, the news agency PTI reported on Saturday (June 3) that the government said there is “no therapeutic justification” for these medicines and that they may involve “risk” to people.

Which drugs have been banned?

The banned drugs include those for treating common infections cough and fever- combinations such as nimesulide + paracetamol dispersible tablets, chlorpheniramine maleate + codeine syrup, pholcodine + promethazine, amoxicillin + bromhexine and bromhexine + dextromethorphan + ammonium chloride + menthol, paracetamol + bromhexine+ phenylephrine + chlorpheniramine + guaiphenesin and salbutamol + bromhexine.

The move comes after recommendations by an expert committee.

The committee said 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,” as per the notification.

“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 added.

What are FDC drugs?

FDC are drugs which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. Back in 2016, the central government announced the ban on 344 drug combinations after an expert panel said they were being sold to patients without scientific data and the order was challenged by the manufacturers in court. The currently banned 14 FDCs are a part of these 344 drug combinations.

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