Govt bans high-dose Nimesulide oral formulations

The Government of India has prohibited the manufacturing, sale and distribution of all oral formulations containing Nimesulide above 100 mg with immediate effect. The decision was notified by the Ministry of Health and Family Welfare through a gazette notification.

Legal basis for the ban

The prohibition has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, following consultations with the Drugs Technical Advisory Board (DTAB). The government stated that the continued use of such formulations is likely to involve risk to human health.

Safety concerns and expert recommendations

Nimesulide, a non-steroidal anti-inflammatory drug (NSAID) commonly used for the treatment of acute pain, has been associated with liver toxicity in some cases.
The ban on certain formulations was recommended by the Indian Council of Medical Research (ICMR) after reviewing the drug’s effects on adults. These recommendations were subsequently accepted by an expert committee under the country’s apex drug regulatory authority.

Availability of safer alternatives

The Health Ministry noted that safer alternative medicines for pain management are already available in the market, strengthening the case for restricting higher-dose Nimesulide formulations.