**Executive Summary**
This document is a notification from the Ministry of Health and Family Welfare, dated December 29, 2025, prohibiting the manufacture, sale, and distribution of oral formulations containing Nimesulide above 100 mg in immediate release dosage form. This decision, effective immediately, is based on concerns about safety and the availability of safer alternatives. The notification is issued under the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940.
**Key Points / Main Content**
* **Prohibition:** All oral formulations containing Nimesulide above 100 mg in immediate release dosage form are prohibited.
* **Justification:**
* The Central Government is satisfied that using these formulations is likely to pose a risk to human beings.
* Safer alternatives to the drug are available.
* The Central Government has concluded that it is necessary and expedient to ban the drug in the public interest
* **Legal Basis:** The prohibition is enacted under Section 26A of the Drugs and Cosmetics Act, 1940.
* **Consultation:** The decision follows consultation with the Drugs Technical Advisory Board.
* **Effective Date:** The prohibition is effective immediately.
**Impact Analysis**
**Pharmaceutical Manufacturers**
* **Impact:** Manufacturers producing oral formulations with more than 100 mg of Nimesulide in immediate release dosage form will no longer be able to manufacture, sell, or distribute these products.
* **Action Required:** Immediately cease the manufacture, sale, and distribution of the specified formulations.
**Distributors and Retailers**
* **Impact:** Distributors and retailers will no longer be able to sell or distribute oral formulations with more than 100 mg of Nimesulide in immediate release dosage form.
* **Action Required:** Immediately cease the sale and distribution of the specified formulations.
**Patients / Consumers**
* **Impact:** Patients will no longer have access to oral formulations with more than 100 mg of Nimesulide in immediate release dosage form.
* **Action Required:** Consult with their healthcare providers to determine suitable alternative medications.
**Healthcare Professionals**
* **Impact:** Healthcare providers will need to be aware of the prohibition and prescribe alternative medications for patients who require pain relief.
* **Action Required:** Update their prescribing practices to reflect the ban on the specified Nimesulide formulations and advise patients on alternative treatment options.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The Act provides regulatory control over the manufacture, sale, and distribution of drugs and cosmetics in India.
Ministry of Health and Family Welfare: The primary entity issuing the notification regarding the ban on certain formulations of Nimesulide.
Nimesulide: The drug whose oral formulations above 100mg in immediate release dosage form are being prohibited.
Drugs Technical Advisory Board: The advisory body consulted by the Central Government before issuing the notification.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअID.-E3x0xx1 22025-268922
CG-DL-E-30122025-268922
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 5891] नई दिल्ली, मगं लवार, दिसम्ब र 30, 2025/पौष 9, 1947 1947
No. 5891] NEW DELHI, TUESDAY, DECEMBER 30, 2025/PAUSHA 9, 1947 1947
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 29 दिसम्बर, 2025
का.आ. 6091(अ).––केन्द्रीय सरकार इस बात से संतुष्ट है दक 100 जमलीग्राम से ज़्यािा जनमेसुलाइड वाले सभी ओरल
फ़ॉमूूलेिन का इस्ट्तेमाल इंसानों के जलए खतरनाक हो सकता है और इस िवा के सुरजित जवकल्प उपलब्ध हैं;
और, केन्द्रीय सरकार इस बात से संतुष्ट है दक लोगों के जहत में िेि में इंसानों के इस्ट्तेमाल के जलए इस िवा के जनमाूण, जबक्री और जवतरण
पर रोक लगाना आवश्यक और उजचत ह;ै
अतः, अब, केन्द्रीय सरकार, ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 26क द्वारा प्रित्त िजियों का प्रयोग
करते हुए और ओषजध तकनीकी सलाहकार बोडू से परामिू के पश्चात, जनम्नजलजखत िवा के जनमाूण, जबक्री और जवतरण पर तत्काल प्रभाव
से, रोक लगाती ह,ै िो इस प्रकार है: ―
“सभी ओरल फ़ॉमूूलेिन जिनमें इमीजडएट ररलीज़ डोज़ेि फ़ॉमू म ें100 जमलीग्राम से ज़्यािा जनमेसुलाइड होता है।”
[फा.स.ं एक्स.11035/100/2024-डीआरएस]
हष ू मंगला, संयुि सजचव
8807 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
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.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.