14 FDC drugs including Nimesulide, Paracetamol, banned in India

The Indian government has banned 14 FDC drugs due to their “no therapeutic justification” and potential risk to individuals. This is in response to the recommendations of an expert committee and the Health Ministry.

In response to the suggestions of an expert committee, the Central Government has put a ban on 14 FDC (Fixed Dose Combination) drugs in the country. According to the government these drugs have “no therapeutic justification” and may pose a “risk” to individuals. The Health Ministry had made a statement on the subject.

Paracetamol and Nimesulide dispersible tablets, as well as Chlopheniramine Maleate and Codeine syrup, are among the 14 fixed dosage combination medications.

These banned drugs included those used to cure common infections, such as: Chlopheniramine Maleate Codeine Syrup, Nimesulide Paracetamol dispersible tablets, Paracetamol Bromhexine Phenylephrine Chlorpheniramine Guaiphenesin and Salbutamol Bromhexine, etc.

“No therapeutic justification for this FDC (fixed dose combination) and the FDC could pose a danger to humans,” concluded the expert group. Thus, under section 26 A of the Drugs and Cosmetics Act, 1940, this FDC must be banned for public good. Given the circumstances, any limitation or restriction allowing patient usage is unjustifiable.”

“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 Health Ministry notification stated.

In 2016, the government banned the manufacture, sale, and distribution of 344 drug combinations after a Supreme Court-appointed expert panel found they were being sold to patients without scientific data. The manufacturers challenged the order in court. 344 medication combinations include the 14 prohibited FDCs.