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Date: 12-Mar-2025 Category: Extra Ordinary State: Union Government Country: India

Banning of Chloramphenicol and Nitrofurans in food rearing animal systems

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

  • The gazette notification prohibits the import, manufacture, sale, and distribution of Chloramphenicol and Nitrofurans, including their formulations, for use in any food-producing animal rearing system.

Key Changes

  • The Central Government prohibits Chloramphenicol and its formulations for use in food producing animal rearing systems.
  • The Central Government prohibits Nitrofurans and its formulations for use in food producing animal rearing systems.
  • The prohibition is with immediate effect.
  • The decision is based on the availability of safer alternatives and the potential risk associated with these drugs in food-producing animals.
  • The decision was made after consulting with the Drugs Technical Advisory Board.

Impact Analysis

Impact on Animal Rearing Industry

  • The industry may need to educate farmers and other stakeholders about the new regulations and alternative treatments.

Impact on Pharmaceutical Companies

  • There may be financial implications for these companies.

Impact on Consumers

  • Increased consumer confidence in the safety of animal products.

Suggested Action Items

  • Engage with international regulatory bodies to align with global best practices.

Key Entities Referenced

Central Government: The authority issuing the notification and responsible for enforcing the ban. Drugs and Cosmetics Act, 1940: The legislation under which the Central Government is exercising its powers to prohibit the drugs. Section 26A of the Drugs and Cosmetics Act, 1940: The specific section of the Drugs and Cosmetics Act that grants the Central Government the power to prohibit the manufacture, sale and distribution of drugs. Drugs Technical Advisory Board: The advisory body consulted by the Central Government before issuing the prohibition. Chloramphenicol: An antibiotic drug prohibited for use in food-producing animals. Nitrofurans: A class of antimicrobial drugs prohibited for use in food-producing animals.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-13032025-261585 CG-DxLx-xEG-I1D3H0x3x2x0 25-261585 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 1145] नई दिल्ली, बुधवार, माच च12, 2025/फाल्ग नु 21, 1946 No. 1145] NEW DELHI, WEDNESDAY, MARCH 12, 2025/PHALGUNA 21, 1946 स्ट्व ास्ट्् य और पररवार कल्य ाण मत्रं ालय (स्ट्व ास्ट्् य और पररवार कल्य ाण जवभाग) अजधसचू ना नई दिल्ली, 12 माच,च 2025 का.आ. 1158(अ).—केन्‍दर्ीय सरकार का यह समाधान हो जाता ह ैकक क्ल् ोरैम््फेननकॉल या नाइट्रोफ्यूरान ओ्षनधयों वाली ओषनध नवननर्मिनतयों के उपयोग स े ककसी भी खाद्य उत््पादक पशु पालन प्रणाली में जोनखम उत््पन्‍द्न होन े की संभावना ह,ै जबकक उक्त् ओषनधयों के सरु नित नवकल््प उपलब््ध ह;ैं और केन्‍द्रीय सरकार का यह समाधान हो जाता ह ै कक ककसी भी खाद्य उत््पादक पशुपालन प्रणाली म ें उपयोग के नलए क्ल् ोरैम््फेननकॉल या नाइट्रोफ्यूरान ओषनधयों वाली सभी नवननर्मिनतयों के आयात, नवननमािण, नवक्रय और नवतरण को प्रनतनषद्ध करना लोकनहत म ेंआवश््यक और समीचीन ह;ै अत:, अब केन्‍दर्ीय सरकार और ओषनध और प्रसाधन सामग्री अनधननयम, 1940 की धारा 26 के द्वारा प्रदत््त शनियों का प्रयोग करत ेहुए, और ओषनध तकनीकी सलाहकार बोर् िस ेपरामश िकरन ेके पश््चात्, ककसी भी खाद्य उत््पादक पशु पालन प्रणाली म ेंउपयोग के नलए ननम्न् नलनखत ओषनधयों के आयात, नवननमािण, नवक्रय और नवतरण को तत्क् ाल प्रभाव स ेप्रनतनषद्ध करती ह,ै अर्ाित – 1698 GI/2025 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] “(1) क्ल् ोरैम््फेननकॉल और इसकी नवननर्मिनतयां; और (2) नाइट्रोफ्यूरान और इसकी नवनननमर्तियां।” [फा. सं. एक् स. 11035/127/2024-डीआर] जनजखल गिराि, संयक्ु त सजचव MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 12th March, 2025 S.O. 1158(E).—Whereas the Central Government is satisfied that the use of drug formulations containing Chloramphenicol or Nitrofurans drugs are likely to involve risk in any food producing animal rearing system 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 import, manufacture, sale and distribution of all formulations containing Chloramphenicol or Nitrofurans drugs for use in any food producing animal rearing system; 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 import, manufacture, sale and distribution of the following drugs, for use in any food producing animal rearing system, with immediate effect, namely - “ (1) Chloramphenicol and its formulations; and (2) Nitrofurans and its formulations. ”. [F. No. X.11035/127/2024-DR] NIKHIL GAJRAJ, 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.

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