By Teena Thacker
Copyright indiatimes
New Delhi: Makers of anti-inflammatory drug nimesulide will be required to display cautionary warning labels that the drug be used only as a second-line treatment for patients 12 years and above after all the first-line options are exhausted.The market for nimesulide formulations in India is about ₹500 crore, expanding at 11% over the past 12 months, as per data from market research firm PharmaTrac.The apex Indian drug regulator-Central Drugs Standard Control Organization-has conveyed the decision to the state level agencies.According to the September 15 circular the box warning should also mention that the drug must not be used in pregnant, lactating and women planning for pregnancy. Also, the label must add that it should not be used in patients with renal and hepatic impairment and should not be co-administered with other hepatotoxic and renal toxic drugs.The government decision comes on the back of a report by the Indian Council of Medical Research, which was tasked by the health ministry to study the impact of nimesulide on adults amid concerns that the drug could cause liver damage in some patients.Live EventsAdd as a Reliable and Trusted News Source Add Now!
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Read More News onNimesulide warning labelNimesulide side effectsNimesulide drug regulationsNimesulide liver damageIndian drug regulatory updatenimesulide formulations marketCentral Drugs Standard Control OrganizationICMR report on nimesulide
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(You can now subscribe to our Economic Times WhatsApp channel)Read More News onNimesulide warning labelNimesulide side effectsNimesulide drug regulationsNimesulide liver damageIndian drug regulatory updatenimesulide formulations marketCentral Drugs Standard Control OrganizationICMR report on nimesulide(Catch all the Business News, Breaking News, Budget 2025 Events and Latest News Updates on The Economic Times.) Subscribe to The Economic Times Prime and read the ET ePaper online….moreless