Centre Bans High-Dose Nimesulide Oral Medicines Over Safety Concerns

The Voice of Chandigarh 

In a significant move aimed at protecting public health, the Union Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of high-dose oral formulations of the painkiller nimesulide with immediate effect.

According to the notification, all immediate-release oral formulations of nimesulide containing more than 100 mg—including tablets and syrups—have been prohibited across the country. The decision has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, following recommendations from expert bodies such as the Drugs Technical Advisory Board (DTAB) and the Indian Council of Medical Research (ICMR).

Health authorities have cited potential risks of liver toxicity associated with higher doses of nimesulide as the primary reason for the ban. The government has stated that safer and equally effective alternatives are available, making the continued use of high-dose formulations unjustifiable.

Nimesulide is a widely used non-steroidal anti-inflammatory drug (NSAID) prescribed for pain and fever. However, it has faced regulatory scrutiny globally, with several countries either banning or restricting its use due to safety concerns.

Officials clarified that nimesulide formulations of 100 mg or below remain permitted, subject to existing prescription norms. State drug controllers have been directed to ensure strict compliance and remove banned products from the market.

The move is part of the government’s broader efforts to strengthen drug safety regulation and prevent adverse health outcomes linked to irrational or high-risk drug formulations.