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Centre Bans High-Dose Nimesulide Oral Drugs
The Union Health Ministry has banned the manufacture, sale and distribution of oral nimesulide formulations containing more than 100 mg in immediate release form. The decision was taken under provisions of the Drugs and Cosmetics Act after a review of safety data and expert recommendations. Authorities said higher doses of the drug pose increased health risks and that safer alternatives are widely available for pain and fever management.
Scope of the ban clarified
The ban applies only to oral immediate release formulations exceeding 100 mg. Lower dose nimesulide tablets and other approved formulations remain permitted. Officials said the move is aimed at reducing the risk of adverse drug reactions, particularly liver related complications, which have been associated with higher doses of the medicine. Nimesulide is a non steroidal anti inflammatory drug commonly prescribed for pain, inflammation and fever.
Rationale behind the decision
Health authorities noted that the therapeutic benefit of higher dose nimesulide does not outweigh the potential risks. Expert committees observed that comparable pain relief can be achieved through other medicines with a better safety profile. The government also reiterated that nimesulide should be used cautiously and only when alternative treatments are unsuitable.
Impact on patients and manufacturers
Pharmaceutical companies manufacturing high dose nimesulide tablets have been directed to stop production and withdraw existing stocks from the market. Doctors have been advised to avoid prescribing doses above the permitted limit and guide patients towards safer options. Patients currently using high dose formulations have been urged to consult healthcare professionals for appropriate substitutes.
