WAQAR MANZOOR
New Delhi, Dec 31: (KH) The Union Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of all oral formulations containing nimesulide above 100 mg, citing potential risks to human health.
According to an official notification issued on Monday, the decision was taken following recommendations by the Indian Council of Medical Research (ICMR), India’s apex health research body. The move aims to ensure patient safety, as the use of higher-dose oral nimesulide formulations has been found to pose health risks, while safer therapeutic alternatives are available.
“The Central Government is satisfied that the use of all oral formulations containing nimesulide above 100 mg in immediate-release dosage form is likely to involve risk to human beings,” the notification stated.
Invoking its powers under Section 26A of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board, the Centre has ordered an immediate prohibition on the manufacture, sale, and distribution of the said drug for human use across the country.
The ban comes into effect with immediate effect in the interest of public health and patient safety.
