India's government banned all oral nimesulide formulations above 100 mg due to health risks, following ICMR's recommendation.

The Indian government prohibited the manufacture, sale, and distribution of all oral formulations of nimesulide above 100 mg for human use. This decision was based on findings by the Indian Council of Medical Research that highlighted serious health risks, especially for children under 18 and elderly people over 60. The ban replaces previous restrictions targeting pediatric and veterinary use and affects a market worth Rs 497 crore. The ban matters as it aims to reduce adverse reactions and protect public health by promoting safer alternatives.