Is nimesulide banned in India? Oral formulations above 100 mg, older combination bans and what to check

Reports and a state drug-control advisory say the Central Government prohibited the manufacture, sale or distribution of oral nimesulide formulations above 100 mg in immediate-release form for human use, under Section 26A of the Drugs and Cosmetics Act, 1940.

We could not retrieve the gazette text itself. The notification number and exact wording are marked pending official text. Older prohibitions on certain nimesulide combinations and on use in children under 12 are in the CDSCO list and are verified from it.

Reported scope: all oral formulations containing nimesulide above 100 mg in immediate-release dosage form, for human use. The prohibition covers manufacture, sale or distribution.

Reported legal basis: Section 26A of the Drugs and Cosmetics Act, 1940, after consulting the Drugs Technical Advisory Board (DTAB).

CDSCO minutes of the DTAB meeting of 24 April 2025 are indexed as recommending this prohibition. The scanned minutes could not be read as text, so we rely on the search summary for that wording.

Read the pack label for the strength per tablet or per dose, and for words such as sustained release or extended release.

If the label shows nimesulide 100 mg or less, it falls outside the reported prohibition. If it shows more than 100 mg in a standard tablet or similar oral form, ask the pharmacist about the notification.

Combinations containing nimesulide are covered by older notifications, shown in the table below. Use the IMCURE banned medicine checker for combinations.

Whether a particular product suits a given prescription is a matter for your doctor and pharmacist.

Pending official text. Press reports date the Ministry of Health and Family Welfare notification to 29 December 2025 and describe it as effective immediately. One outlet gives the number S.O. 6091(E), which we could not confirm from the gazette.

A Goa Directorate of Food and Drugs Administration advisory dated 13 January 2026 repeats the prohibition wording, which supports that a Central notification exists.

Reports say strengths of 100 mg or below, and sustained or extended release forms above 100 mg, are not covered. Topical forms are reported as outside the ban. These points are from press reports, not the gazette.

CDSCO's list in our database has 23 nimesulide rows. They include a 2011 entry (GSR 82(E), 10 February 2011) for nimesulide formulations for human use in children below 12 years, and combination entries notified from 2016 and 2018. The table gives each with its page.

Answers separate what is verified in the CDSCO list from what is reported in the press. The gazette text for the 2025 prohibition is pending.