Centre bans oral formulations of nimesulide above 100mg

The Union Health Ministry has banned oral formulation of nimesulide above 100mg in immediate release form.

“Strengths below 100mg or strengths above 100mg in other types of release (such as sustained release, extended release) are not under this ban. Non-oral formulations like topical gels/creams or suppositories are also not banned,” said a senior Ministry official.

Nimesulide is a non-steroidal anti-inflammatory drug used for its pain-relieving, anti-inflammatory, and fever-reducing effects. It is a prescription medication primarily intended for short-term, second-line treatment (when other medicines have failed) due to concerns over potential liver toxicity. 

The Ministry has banned the manufacture, sale and distribution of the oral formulations citing serious risks to health, the official notification, issued earlier this week, said.

“The Central government is satisfied that the use of all oral formulations containing Nimesulide above 100mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available,” the notification said.

“Now, therefore, in exercise of the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 and after consultation with the Drugs Technical Advisory Board, the Centre, hereby prohibits the manufacture, sale and distribution of the drug, with immediate effect,” the notification said.

Nimesulide was first approved in Italy in 1985 and is currently available in more than 50 countries. The Drug Controller General of India approved nimesulide in 1995.

Fixed-drug combinations have gained widespread acceptance owing to their superior therapeutic effectiveness and safety, enhanced patient compliance, reduced patient cost compared to single-drug therapies, and improved adherence.

According to the product characteristics summary, nimesulide is approved for the treatment of acute pain, symptomatic relief in painful osteoarthritis, and primary dysmenorrhea, as well as for managing fever, acute tendinitis, and postoperative dental pain in individuals above the age of 12 years, noted a study titled ‘Nimesulide: Critical Appraisal of Safety and Efficacy in Acute Pain’.