HYDERABAD: The Telangana Drugs Control Administration (TDCA) has ordered an immediate ban on all oral formulations of the widely-used painkiller Nimesulide exceeding 100 mg, following a Union government directive citing serious health risks.
The prohibition, issued through a gazette notification on Monday, December 29, by the Union Ministry of Health and Family Welfare, comes into effect immediately across the state, the TDCA said in a press release.
What is Nimesulide?
Nimesulide is a non-steroidal anti-inflammatory drug commonly prescribed as a pain killer and to reduce fever. The medication, which entered the Indian market in 1995, is used to treat headaches, backaches, menstrual pain, muscle pain, arthritis and post-operative discomfort.
Unlike paracetamol, which typically provides relief for four to six hours, Nimesulide can reduce pain and fever for 12 to 18 hours. The drug has never been approved in major countries, including the United States, the UK, Canada, Australia and Japan due to longstanding safety concerns.
The ban follows mounting evidence of severe liver toxicity associated with higher doses of Nimesulide. Medical experts warn that the drug can cause acute liver injury, which in severe cases may lead to liver failure requiring emergency transplantation or even death.
TDCA to withdraw the drug from pharmacies, supply chains
The TDCA has strongly advised the public to immediately stop using all oral Nimesulide formulations above 100 mg. Patients currently taking such medications should discontinue use and consult their medical practitioner for safer alternative treatments, which are easily available, it said.
The drug controller also warned people not to purchase or store the medicine “under any circumstances,” adding that it is taking steps to withdraw it from pharmacies and supply chains across the state.The TDCA said that if the medicine is found being sold or distributed, the public may bring the same to the notice of the nearest Drugs Inspector / Drugs Control Administration office.
