India Pharma Outlook Team | Wednesday, 23 April 2025
The Indian Council of Medical Research (ICMR) has instructed a ban on all formulations of the broadly used painkiller Nimesulide above 100 mg. The proposal, which aims at patients under 18 and those aged 60 and above, underscores deep safety concerns and has been delivered to the Drugs Technical Advisory Board (DTAB) for final consideration.
The Nimesulide demand in India is worth Rs 497 Cr and rising at 11% annually, may witness a mass disruption if the DTAB executes the proposed ban. Dr Reddy’s Nise, Nimulid, Nimtex and Nicip are the top-selling brands that overwhelm the anti-inflammatory drug space, with millions of prescriptions issued annually.
ICMR’s findings are alarming: "All experts agreed that nimesulide is contraindicated in elderly population (60 and above)." The study related Nimesulide to extreme negative effects like gastrointestinal bleeding, liver injury, perforation, and poor fertility in women. It is currently recommended that black box warning be added to all Nimesulide containing products.
"The evidence supporting the ban of Nimesulide in the adult population is compelling," ICMR stated, highlighting the improper risks given the availability of safer choices. With earlier bans already in place for pediatric and veterinary usage, the upcoming decision could change India’s pharmaceutical landscape and sustain the country's commitment to patient safety.