Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-30122025-268922
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
NEW DELHI, TUESDAY, DECEMBER 30, 2025/PAUSHA 9, 1947
8807 GI/2025
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 29th December, 2025
S.O. 6091(E).—Whereas the Central Government is satisfied that the use of all oral formulations
containing Nimesulide above 100 mg in immediate release dosage form are likely to involve risk to human beings
and that safer alternatives to the said drug is available;
And, whereas, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit
the manufacture, sale and distribution of the said drug in the country for human use;
Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of
1940), and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits
the manufacture, sale and distribution of the following drug, with immediate effect, namely:-
"All oral formulations containing Nimesulide above 100 mg in immediate release dosage form."
[F. No. X.11035/100/2024-DRS]
HARSH MANGLA, Jt. Secy.
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and Published by the Controller of Publications, Delhi-110054.