The Indian Council of Medical Research (ICMR) has suggested banning all Nimesulide preparations above 100 mg for adults and called for the imposition of a black box warning on all products with the drug on a mandatory basis. These suggestions have been made after a thorough review by ICMR on the safety profile of Nimesulide, at the behest of the Drug Technical Advisory Board (DTAB).

Key Highlights

Ban on High-Dose Formulations Proposed

• ICMR recommends a ban on all Nimesulide products with a strength of over 100 mg.

• The report recommends that Nimesulide be prescribed as a second-line drug only after all the first-line drugs have failed.

Black Box Warning for All Nimesulide Products

• A black box warning—reserved for the most critical safety announcements—must appear on all labeling and promotional materials.

• The warning will be used to inform doctors and patients of the drug's potential dangers, particularly liver toxicity.

Use Restrictions and Population Warnings

• ICMR suggests prohibition of use of the drug in people less than 18 years and more than 60 years of age.

• The drug must not be used in pregnant and lactating females, pregnant and planning females, and liver- and kidney-impaired patients.

OTC Sales Under Scrutiny

• In spite of being a Schedule H drug, Nimesulide is extensively marketed over-the-counter in India.

• ICMR advises prescription-only sale to regulate misuse and limit risk.

Background and Global Context

• Originally introduced in Italy in 1985, Nimesulide is banned or restricted in most countries because of safety reasons.

• It is still commonly used in India, however, despite a 2011 prohibition against using it on children under 12 years old.

• Its veterinary application was prohibited in February of 2025 as part of a vulture conservation project.

Statements of Officials or Leaders

• "The recommendations in this report underscore the requirement of tighter regulatory surveillance and better public awareness of use of Nimesulide," the ICMR report declared.

• The recommendation has been perused by the DTAB and is to be implemented after sanction by the Drug Controller General of India (DCGI), according to a top official.

Nimesulide remains a widely used pain and fever medicine in India despite international bans and growing concerns about liver toxicity. With ICMR’s latest recommendations, stricter regulation may soon follow. The industry now awaits final decisions from DTAB and DCGI that could redefine the drug’s availability and safety standards in India.