Over 14 years after the Centre banned nimesulide in the treatment of children, it has banned all oral formulations of Nimesulide over 100 mg in immediate release form, due to its risk to humans, and because safer alternatives are available.
Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) that is used in bringing down fever. It has been banned for use in children below 12 years of age, given its health risks, including liver toxicity (2011). A year ago, (December 2024) the Centre banned all forms of nimesulide in veterinary use, as well.
The latest development comes following consultations with the Drugs Technical Advisory Board (DTAB), a recent notification from the Union Health Ministry said. A ministry official further clarified, strengths below 100 mg or strengths above 100mg in other forms of release (eg-Sustained release, extended release) did not come under the latest ban. Non-oral formulations including topical gels/creams or suppositories are also not banned, he said.
According to the minutes of the 92nd DTAB report (April 2025), the board had recommended that Nimesulide be used only as a second line drug, after exhausting first line options. Other recommendations included that it not be used in pregnant, lactating and women planning for pregnancy; and in patients with renal and hepatic impairment, besides not being co-administered with other hepatotoxic and renal toxic drugs.
While there may not be many companies having the oral drug in strengths above 100 mg, the Centre’s move is aimed at stopping any sale in this category, even if it is harmful to just one person, Vishal Manchanda, Senior Vice-President (Institutional Research) with Systematix Group told businessline. The entire nimesulide segment, including combination versions, is pegged at about ₹500 crore, and it includes companies such as Alkem, Dr Reddy’s Laboratories, Mankind, Cipla and Emcure, who have brands containing the drug.
Published on December 31, 2025