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.
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