Health Ministry Bans 14 FDC Drugs in India, Citing Potential Risks

New Delhi: The Indian government has recently implemented a ban on 14 fixed-dose combination drugs, including popular medications like Nimesulide and Paracetamol dispersible tablets and Chlorpheniramine Maleate and Codeine syrup.

The decision was made by the Union Health Ministry, which issued a notification highlighting the lack of therapeutic justification for these medicines and the potential risks they pose to individuals. The banned drugs encompass various treatments for common ailments such as infections, cough, and fever.

This move follows recommendations put forth by an expert committee, which emphasized the absence of therapeutic justification and the potential risks associated with these fixed dose combinations (FDCs). Consequently, under section 26 A of the Drugs and Cosmetics Act of 1940, the manufacture, sale, and distribution of these FDCs will be prohibited in the interest of public welfare.

The notification states that any form of regulation or restriction allowing the use of these drugs in patients is not justifiable. Based on the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government has determined that it is necessary and expedient to prohibit the manufacture, sale, and distribution of these drugs for human use in the country. This decision is motivated by the larger public interest and the need to ensure the safety of individuals.

Fixed-dose combination drugs are medications that contain two or more active pharmaceutical ingredients (APIs) in a fixed ratio. This ban on 14 FDCs is part of a larger initiative that started in 2016 when the government prohibited the manufacture, sale, and distribution of 344 drug combinations.

The decision to ban these drug combinations was made after an expert panel, established under the direction of the Supreme Court, determined that they were being sold to patients without proper scientific data. Manufacturers challenged the initial order in court, leading to ongoing legal proceedings.