May 21, 2024

According to the government, there is “no therapeutic justification” for 14 fixed dose combination pharmaceuticals, including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup, and they may pose a “risk” to patients.

photo medication pills on white plastic container
Photo by Anna Shvets on

On Friday, the Union Health Ministry released a notification regarding this.

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

An expert committee’s suggestions led to the decision.

According to the expert committee, “this FDC (fixed dose combination) has no therapeutic justification, and it may pose a risk to humans.” Therefore, under section 26 A of the Drugs and Cosmetics Act of 1940, it is necessary to prohibit the manufacturing, sale, or distribution of this FDC in the interest of the general public. Given the foregoing, it is not reasonable to impose any regulations or restrictions that would prevent use in patients.

And while the Central Government is convinced that it is necessary and expedient in the public interest to regulate by prohibiting the manufacture for sale, sale, and distribution of drugs for human use based on the Expert Committee’s and Drugs Technical Advisory Board’s recommendations,

After a Supreme Court-ordered expert panel found that 344 drug combinations were being sold to patients without adequate scientific support, the government announced a ban on their production, sale, and distribution in 2016. The order was subsequently contested in court by the manufacturers.

Of all 344 medication combinations, 14 FDCs are now prohibited.

Vijay Laxmi Rai

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