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Date: 30-Dec-2024 Category: Extra Ordinary State: Union Government Country: India

Banning Nimesulide for animal use.

Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare

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Executive Summary & Key Takeaways

What it means

  • This gazette notification issued by the Ministry of Health and Family Welfare, Government of India, prohibits the manufacture, sale, and distribution of Nimesulide and its formulations for animal use with immediate effect.
  • The government has determined that Nimesulide poses a risk to animals and safer alternatives are available.

Key Changes

  • The notification imposes an immediate ban on the manufacture, sale, and distribution of all formulations of Nimesulide intended for animal use.
  • This action is taken under Section 26A of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board.
  • The ban is effective from December 30, 2024.

Impact Analysis

Animal Health Industry

  • Animal owners will need to adapt to using alternative medications for their animals, which may involve changes in treatment protocols and costs.

Government

  • The Drugs Technical Advisory Board will continue to monitor the situation and advise on any further actions.

Suggested Action Items

  • The government should conduct regular inspections to ensure compliance with the ban.

Key Entities Referenced

Ministry of Health and Family Welfare: The government ministry responsible for issuing the notification and overseeing the ban on Nimesulide for animal use. Drugs and Cosmetics Act, 1940: The legislation under which the ban is enacted, specifically using the powers conferred by section 26A. Drugs Technical Advisory Board: The advisory body that was consulted before the ban was implemented. Nimesulide: The specific drug and its formulations that are banned for animal use.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-31122024-259761 xxxGIDHxxx CG-DLxx-xEG-I3D1E1x2x2x0 24-259761 असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 5213] नई दिल्ली, सोमवार, दिसम् बर 30, 2024/पौष 9, 1946 No. 5213] NEW DELHI, MONDAY, DECEMBER 30, 2024/PAUSHA 9, 1946 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 30 दिसम् बर, 2024 का.आ. 5633(अ).—केंद्र सरकार को इस बात का समाधान ह ै दक जनमेसुलाइड युक्त औषजध फॉमूूलेिन के उपयोग स े पिुओं को खतरा होने की संभावना ह।ै और, उक्त औषजधयों के सुरजित जवकल्प भी उपलब्ध ह;ैं और, केंद्रीय सरकार को इस बात का समाधान ह ै दक पिुओं के उपयोग के जलए जनमेसुलाइड के सभी फॉमूूलेिन के जनमाूण, जबक्री और जवतरण को प्रजतबंजधत करना सावूिजनक जहत म ें आवश्यक और समीचीन ह;ै अब! इसजलए, केंद्रीय सरकार, औषजध एवं प्रसाधन सामग्री अजधजनयम, 1940 की धारा 26क द्वारा प्रित्त िजक्तयों का प्रयोग करते हुए, तथा औषजध तकनीकी सलाहकार बोडू के परामि ू के पश्चात, जनम्नजलजखत औषजध के जनमाूण, जबक्री और जवतरण पर तत्काल प्रभाव से प्रजतबंध लगाती ह,ै यथाथ:ू - “पि ुउपयोग के जलए जनमसे लु ाइड और इसके फॉमलूू िे न” [फा. स.ं X. 11035/100/2024-डीआरएस] रािीव वधावन, सलाहकार (लागत) 8464 GI/2024 (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 30th December, 2024 S.O. 5633(E).—WHEREAS the Central Government is satisfied that the use of drug formulations containing Nimesulide are likely to involve risk to animals. And, whereas, safer alternatives to the said drugs are 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 all formulations of Nimesulide for animal use; Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits the manufacture, sale and distribution of the drug, with immediate effect, namely:- “Nimesulide and its formulation for animal use” [F. No. X. 11035/100/2024-DRS] RAJIV WADHAWAN, Adviser (Cost) 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.

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