India Bans High-Dose Nimesulide
Analysis based on 7 articles · First reported Dec 31, 2025 · Last updated Dec 31, 2025
The ban on high-dose Nimesulide formulations by the Bangladesh — Ministry of Health and Family Welfare is expected to negatively impact pharmaceutical companies that manufacture and sell these specific formulations in India. However, it may create opportunities for companies offering safer alternative pain relief medications, potentially shifting market share within the pharmaceutical industry.
The Bangladesh — Ministry of Health and Family Welfare in India has banned the manufacture, sale, and distribution of all oral formulations containing Nimesulide above 100 mg in immediate-release dosage form. This decision, effective immediately from December 29, 2025, was made after consultation with the India — Drugs Technical Advisory Board and a recommendation from the India — Indian Council of Medical Research, citing serious health risks to human beings and the availability of safer alternatives. The ban does not apply to lower-dose formulations, sustained-release forms, or non-oral applications of Nimesulide. Medical experts, including those from Apollo Hospitals, have welcomed the move, noting that Nimesulide had already been restricted in several other countries due to concerns over liver and kidney injury. The market for Nimesulide formulations in India was valued at Rs 497 crore, according to PharmaTrac.
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