The Union Health Ministry has imposed an immediate ban on the manufacture, sale, and distribution of oral medicines containing more than 100 milligrams of Nimesulide in immediate-release form, citing potential health risks and the availability of safer alternatives.
The decision, notified on December 29, 2025, has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, following consultations with the Drugs Technical Advisory Board (DTAB).
The ban applies nationwide and mandates pharmaceutical companies and distributors to withdraw all affected high-dose formulations from the domestic market with immediate effect. Lower-dose Nimesulide preparations and other pain relief or fever medications will remain legally available.
High-dose immediate-release Nimesulide formulations have been identified as posing potential health risks, particularly to the liver, while safer therapeutic alternatives exist. Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), was first introduced in Italy in 1985 and approved for use in India in 1995. Over the years, it has been widely prescribed, generating around Rs 500 crore in annual sales in India, despite scrutiny over its safety profile in several countries.
The DTAB recommended the restriction on high-dose formulations as an interim measure while further studies are conducted by the Indian Council of Medical Research (ICMR) to assess the drug’s safety in specific population groups, including children under 12, adolescents between 12 and 18, and elderly patients above 60.
The government emphasized that the prohibition of high-dose immediate-release Nimesulide is necessary in the public interest, reflecting a precautionary approach to safeguard public health.
