Government Bans High-Dose Nimesulide Over Safety Concerns

• India has banned the manufacture, sale, and distribution of oral Nimesulide formulations above 100 mg in immediate-release dosage form.
• The ban, effective immediately from December 29, 2025, cites risks to human health and the availability of safer alternatives.
• Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has faced global scrutiny for potential liver toxicity and adverse effects.
• The prohibition falls under Section 26A of the Drugs and Cosmetics Act, 1940, following Drugs Technical Advisory Board consultation.
• This move reinforces India's commitment to stricter drug safety standards and pharmacovigilance.

Why It Matters: India bans high-dose Nimesulide to protect public health, emphasizing drug safety.