The Union Health Ministry has banned the manufacturing, sale and distribution of oral formulations of pain and fever medications that contain Nimesulide above 100 milligrams in immediate-release dosage form, several reports have confirmed. The drug was prohibited under Section 26A of the Drugs and Cosmetics Act, 1940 after consultation with the Drugs Technical Advisory Board.
What is Nimesulide and why the ban matters?
Nimesulide is a non‑steroidal anti‑inflammatory drug, which has been under global scrutiny for potential liver toxicity and other adverse effects. The Health Ministry’s move aligns with efforts to tighten safety standards. “The use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings, and safer alternatives are available,” a Health Ministry notification cited by multiple reports has said.Even before, Nimesulide has caused some concerns. In 2011, the health ministry banned its paediatric use in children below 12 years of age. ” Nimesulide formulations in children below 12 years of age – Nimesulide containing products are not permitted in many countries in children under 12 years of age. The drug has been considered to be hepatotoxic and children are considered more susceptible to hepatotoxicity,” the government had said then.
Where else is Nimesulide banned?
Several countries in Europe were among the first to act. Nations like Finland, Spain, Ireland and Belgium withdrew nimesulideafter reports linked the drug to serious liver damage, including cases of acute liver failure that sometimes required transplants. In 2007, the European Medicines Agency (EMA) reviewed the drug and concluded that its risks outweighed its benefits for routine pain relief. As a result, its use was either suspended or sharply limited across much of the European Union. Outside Europe, countries like Canada, Japan, the United States, Australia and the UK never approved nimesulidefor human use in the first place, mainly due to safety concerns during early evaluations. The fear wasn’t about mild side effects, but rare yet severe liver toxicity that could develop suddenly, even with short-term use.
