India Bans High-Dose Nimesulide Over Safety Concerns; Manufacturing, Sale Halted

• Government bans all oral Nimesulide formulations exceeding 100mg (Immediate Release Dosage form) due to human health risks.
• Decision by Ministry of Health under Section 26A of Drugs and Cosmetics Act 1940, following Drugs Technical Advisory Board consultation.
• Nimesulide, an NSAID for pain/fever, has faced global safety concerns, particularly regarding liver toxicity.
• Manufacturing, sale, and distribution of high-dose Nimesulide will cease; companies must recall existing batches.
• Move reflects India's increasing strictness on drug safety, though economic impact on large pharma is expected to be minimal.

Why It Matters: India bans high-dose Nimesulide formulations, prioritizing patient safety over potential risks.