
Goa Enforces Ban on High-Dose Oral Nimesulide
The Goa Government has officially enforced a prohibition on all oral formulations of the painkiller nimesulide exceeding 100 mg in immediate-release dosage forms. This state-level action follows a recent directive from the Central Government, which banned the drug nationwide under Section 26A of the Drugs and Cosmetics Act, 1940. The Union Health Ministry’s decision to prohibit the manufacture, sale, and distribution of these specific formulations was made after consultations with the Drugs Technical Advisory Board, citing significant risks to human health and the availability of safer alternatives.
In light of the ban, stringent compliance measures have been rolled out for healthcare professionals and the pharmaceutical supply chain within Goa. Doctors and registered medical practitioners have been explicitly directed to immediately stop prescribing the restricted high-dose nimesulide formulations. Furthermore, pharmacies, retailers, and wholesalers have been instructed to halt all dispensing and stocking of the drug. These establishments are required to identify the banned products, remove them from their shelves, and return all existing inventory back to their respective suppliers.
The nationwide crackdown on higher-dose nimesulide addresses long-standing safety concerns regarding the non-steroidal anti-inflammatory drug, particularly its association with hepatic toxicity. While the drug has been approved for the treatment of acute pain and fever, regulators have progressively narrowed its scope over the years to prioritize patient safety. The current ban adds to earlier restrictions, as nimesulide was already prohibited for pediatric use in children under 12 years of age in 2011, and its use in veterinary applications was banned in January 2025.
