Government Bans Sale, Use of Oral Nimesulide Formulations for Human Use

India’s health authorities have moved to restrict the use of nimesulide by banning the manufacture, sale and distribution of oral formulations exceeding 100 mg for human consumption, marking a significant regulatory step against the widely used painkiller. 

Government Decision and Health Rationale 

The ban follows safety concerns flagged by the Indian Council of Medical Research, which highlighted the drug’s association with liver toxicity that could prove fatal in certain cases.  

In a notification issued late on December 30, the government said it was necessary to prohibit higher-dose oral formulations in the public interest. 

Regulatory History and Expert Review 

Nimesulide has already faced multiple restrictions in India. Its use in children under the age of 12 was banned earlier after reports of severe liver damage, and veterinary use was prohibited in February this year.  

An ICMR assessment later raised concerns about its safety profile even among adults, recommending that the drug be used only as a second-line treatment when safer alternatives fail. 

While some experts pushed for a nationwide ban, the Drug Technical Advisory Board sought further evidence and asked for a detailed review covering adolescents, older adults and children.  

The board acknowledged the drug’s effectiveness for short-term fever and pain relief but supported banning immediate-release oral formulations exceeding 100 mg. 

Global Context and Market Impact 

Originally introduced in Italy in 1985, nimesulide is a non-steroidal anti-inflammatory drug that entered the Indian market in 1995.  

Despite its widespread use domestically, several major countries including the US, UK, Canada, Australia and Japan never approved the drug due to safety concerns. In India, nimesulide currently represents an estimated ₹500 crore market on a moving annual turnover basis. 

Read More: India Imposes Anti-Dumping Duties on China’s Refrigerant Gas and Steel Products! 

Conclusion 

By restricting higher-dose oral formulations of nimesulide, the government has tightened oversight on a commonly prescribed drug while stopping short of a complete ban. The move reflects a balancing act between clinical utility and patient safety, signalling stricter scrutiny of medicines with unresolved risk profiles. 

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