India Bans High-Dose Nimesulide Over Liver Risk Concerns

• Ministry of Health and Family Welfare (MoHFW) banned oral Nimesulide formulations above 100 mg due to potential liver damage.
• Nimesulide, an NSAID for pain and fever, is linked to hepatic risk and was never approved in US, Canada, Japan, Australia.
• The ban, effective immediately from December 29, aims to protect public health based on Drugs Technical Advisory Board (DTAB) recommendations.
• This specific prohibition targets high-dose immediate-release forms, not a blanket ban on all Nimesulide products.
• Patients are advised to consult doctors for alternatives and not to stop medication abruptly.

Why It Matters: India prohibits Nimesulide oral formulations above 100 mg due to liver safety concerns.