Why in news?
Nimesulide, a popular pain‑relief medicine, returned to headlines when India’s health ministry ordered a ban on all oral formulations above 100 mg in late 2025. The decision followed reports of serious side‑effects and recommendations from the Drugs Technical Advisory Board and the Indian Council of Medical Research (ICMR).
Background
Nimesulide is a non‑steroidal anti‑inflammatory drug (NSAID) with analgesic and antipyretic properties. It became widely used in India for relief of pain and fever because it acts quickly and causes relatively little stomach irritation compared with older NSAIDs. However, concerns about liver toxicity and misuse have dogged it for decades:
- Since the early 2000s paediatric formulations have been banned after reports of liver failure in children.
- The drug works by selectively inhibiting cyclo‑oxygenase‑2 (COX‑2), reducing the production of inflammatory prostaglandins, but it can also impair liver detoxification enzymes.
- High doses or prolonged use increase the risk of hepatotoxicity, kidney damage and gastrointestinal bleeding.
New restrictions and guidelines
- Dosage cap: The Union health ministry has prohibited the manufacture, sale and distribution of oral nimesulide tablets or suspensions containing more than 100 mg per dose. Lower‑dose formulations (50 – 100 mg) remain available by prescription.
- Patient warnings: ICMR’s therapeutic guidelines advise against using nimesulide in children under 12 years, pregnant or lactating women and patients with liver or kidney impairment. Doctors should prescribe the lowest effective dose for the shortest possible duration.
- Pharmacy oversight: Pharmacists are directed not to dispense nimesulide without a valid prescription. Over‑the‑counter sales for common ailments like fever or toothache are discouraged.
Why the decision matters
- Public health: By capping the strength of nimesulide tablets, regulators hope to reduce cases of drug‑induced liver injury and curb self‑medication.
- Rational drug use: The move underscores the need for careful prescribing of painkillers and encourages physicians to consider safer alternatives such as paracetamol or ibuprofen.
- Consumer awareness: The ban has sparked discussion about the risks of over‑the‑counter analgesics and the importance of reading labels and consulting health professionals.
Source: News On Air
