The Government of India has banned the pain- and fever-relief drug Nimesulide. Specifically, the order prohibits its manufacture, sale, and distribution. Moreover, the ban applies to all oral immediate-release formulations containing more than 100 mg of the drug. According to the order, Nimesulide poses a significant health risk. Therefore, after reviewing the drug’s effects, the Indian Council of Medical Research (ICMR) recommended this restriction. Notably, studies show that Nimesulide can cause liver toxicity in some cases. Consequently, the Government invoked Section 26A of the Drugs and Cosmetics Act, 1940 to enforce the ban.

In addition, ICMR advised that doctors should use Nimesulide only as a second-line treatment, that too when other medicines fail to provide relief. Furthermore, it recommended that physicians should not prescribe the drug to pregnant or lactating women, women planning pregnancy, or patients with kidney or liver impairment.

Nimesulide

Meanwhile, Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), treats acute pain and fever. However, concerns over hepatic toxicity, especially with prolonged use, have persisted for years. As a result, the Government banned its use in children below 12 years in 2011. Subsequently, in January 2025, authorities also prohibited its veterinary use.

Importantly, ICMR serves as India’s apex biomedical research body. In fact, it functions as a premier health research institution and actively contributes to evidence-based health policies and programmes. Additionally, it frames guidelines, regulations, and policy inputs, and regularly disseminates public-health advisories across sectors.

At the same time, drug regulation in India operates under the Drugs and Cosmetics Act, 1940, which governs the import, manufacture, distribution, and sale of drugs. However, since public health falls under the State List, regulatory authority remains divided between the CDSCO and State drug regulators, leading to opacity and coordination challenges. Consequently, serious issues persist, including widespread substandard and spurious drugs due to weak enforcement, rampant over-the-counter sale of prescription medicines, and severe understaffing of regulatory bodies.

Finally, following the cough-syrup deaths in The Gambia and other countries, the Government mandated the implementation of Good Manufacturing Practices (GMP) for all pharmaceutical manufacturers. Significantly, GMP represents an internationally accepted framework that governs manufacturing standards and quality control, thereby strengthening drug safety and public confidence.