Health Ministry Bans Oral Formulations of Nimesulide Above 100 mg Due to Liver Toxicity
The Union Health Ministry has prohibited the manufacture, sale, and distribution of oral formulations of nimesulide containing more than 100 mg in immediate-release form. The ban, issued under the Drugs and Cosmetics Act, 1940, follows recommendations from the Drugs Technical Advisory Board (DTAB) regarding potential risks of liver toxicity. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) used for acute pain. While high-dose oral forms are banned, strengths below 100 mg, sustained-release versions, and non-oral formulations like topical gels remain permitted for medical use.
Key Points
- Oral nimesulide formulations above 100 mg are banned due to significant risks of liver toxicity.
- The ban applies specifically to immediate-release dosage forms, not sustained-release or topical versions.
- The decision was made after consultation with the Drugs Technical Advisory Board (DTAB).
- Topical gels, creams, and suppositories of nimesulide are not affected by this prohibition.
Exam Facts
- The ban was issued under Section 26A of the Drugs and Cosmetics Act, 1940.
- DTAB stands for Drugs Technical Advisory Board, which provides expert advice on drug safety.
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