Centre Bans High-Dose Nimesulide Tablets Over Serious Health Risks
New Delhi | December 31, 2025 | DeccanLive.com
The Central Government has announced an immediate ban on high-dose Nimesulide tablets used for pain and fever. The ban applies to all fast-acting oral medicines containing more than 100 mg of Nimesulide.
The decision was taken after consultations with the Drugs Technical Advisory Board under Section 26A of the Drugs and Cosmetics Act, 1940. In a notification issued by the Ministry of Health and Family Welfare on December 29, 2025, the government said that using Nimesulide in doses above 100 mg can be dangerous to human life. It also noted that safer alternative medicines are available.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID). It has long been under criticism worldwide due to concerns about severe liver damage. Medical experts warn that high doses of this drug can cause serious liver problems and may even be life-threatening.
According to the government order, the ban applies only to high-dose products meant for human use. Lower-dose medicines and other alternative treatments will continue to be available. Drug manufacturing companies have been instructed to immediately stop production of the affected batches and withdraw them from the market.
Following the central directive, the Telangana Drugs Control Administration (TDCA) has also imposed an immediate ban on Nimesulide tablets above 100 mg in the state. The public has been strictly advised not to buy or store this medicine. People are also asked to inform the nearest drug inspector if the banned medicine is found on sale.
Nimesulide was introduced in India in 1995 and has been used to treat headaches, joint pain, menstrual pain, fever, and post-surgery pain. However, the drug has never been approved in countries such as the United States, the United Kingdom, Canada, Australia, and Japan.
