Centre bans Nimesulide painkiller in oral formulations over 100mg
What's the story
The Centre has banned the manufacture, sale, and distribution of all oral formulations of painkiller Nimesulide containing more than 100 milligrams in immediate-release form for human use. The decision was taken after consultations with the Drugs Technical Advisory Board under Section 26A of the Drugs and Cosmetics Act, 1940. The Ministry of Health and Family Welfare issued a notification on Monday, citing risks to human health from such doses.
Health risks
Safer alternatives to nimesulide available, says government
The government has also pointed out that safer alternatives to Nimesulide are available. The Indian Council of Medical Research (ICMR) had earlier recommended a complete ban on such formulations due to liver damage risks. The drug was first launched in Italy in 1985 and approved in India in 1995 as a non-steroidal anti-inflammatory drug (NSAID).
Global ban
Nimesulide banned in several countries over safety concerns
Despite its popularity in India, Nimesulide has never been approved by the United States, the United Kingdom, Spain, Australia, Canada, Japan, or New Zealand due to safety concerns. The ICMR report highlighted major risks of using Nimesulide in patients below 18 years and those above 60 years of age. In January this year, a complete ban on all formulations of Nimesulide was imposed for veterinary use after studies showed toxicity to vultures.
Market impact
Nimesulide's market value and previous bans
Despite its risks, the market for Nimesulide formulations in India is worth ₹497 crore and has been growing at 11% over the past year. The drug was banned for pediatric use in 2011 after severe hepatotoxicity reports. Earlier, the Drug Technical Advisory Board (DTAB) had suggested further review before recommending a complete ban on Nimesulide.