India bans high-dose oral pills of painkiller Nimesulide, citing safety risks

New Delhi, Dec 31 (UNI) A year after banning Nimesulide for use in animals, the Health Ministry on Monday prohibited the controversial drug for humans in doses above 100 mg, citing safety concerns.

Nimesulide is a commonly prescribed painkiller and fever-relieving medicine in India, which may pose health risks when consumed in higher doses, said the health officials.

In an official order dated December 29, the government placed strict curbs on the manufacture, sale, and distribution of the higher doses of the contested medicine with immediate effect.

The advisory follows the concerns raised by health experts over the possibility of liver damage in some patients, which in certain cases might even turn fatal. The Centre’s decision was also supported by the Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO).

Earlier this year, in January, following advice from the CDSCO panel over the health risks of the drug in animals, the Centre banned Nimesulide from all veterinary formulations. The decision stemmed from the environmental concerns over the declining vulture population in our nation.

The panel warned that nimesulide, widely used as a painkiller for cattle, remained one of the most significant existing threats to vultures.

Bombay Natural History Society and the Indian Council of Agricultural Research–Indian Veterinary Research Institute jointly conducted a study to test the safety reports of the drug in the avian population. The reports revealed that vultures treated with nimesulide died within 24 hours of being administered the drug, pushing the panel to advocate a ban on the drug for animal use.

Nimesulide has been under global scrutiny since the start of the century. Several countries, including Finland, Spain, Ireland, and Singapore, withdrew the drug between 2002 and 2007, as medical experts warned of health risks over long-term use, including elevated liver enzymes, liver toxicity, internal bleeding, clotting disorders, and severe kidney damage.

Meanwhile, India, banned the use in children below 12 years of age since 2011, while allowing the use in older patients, despite the repeated warnings of potential liver damage from experts worldwide.

 

 

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