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Core Purpose

The Central Government prohibits the import, manufacture, sale, and distribution of specified antimicrobial medicinal products and their formulations for animal use under sections 10A and 26A of the Drugs and Cosmetics Act, 1940.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare), through Notification S.O. 4338(E) dated 23rd September, 2025, has prohibited the import, manufacture, sale, and distribution of specific antimicrobials and their formulations for animal use. This action is taken by the Central Government in exercise of powers conferred by sections 10A and 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board. A draft notification, S.O. 2298 (E) dated 22nd May, 2025, was previously published, inviting objections and suggestions within thirty days, but no submissions were received. The prohibition is deemed necessary and expedient in the public interest due to the availability of safer alternatives for animal use drugs. The prohibited products include various groups of antibiotics (e.g., Ureidopenicillins, Carbapenems, Glycopeptides, Oxazolidinones, Fidaxomicin, Plazomicin, Glycylcyclines, Eravacycline, Omadacycline), antivirals (e.g., Amantadine, Baloxavir marboxil, Favipiravir, Molnupiravir, Oseltamivir, Ribavirin, Zanamivir), and antiprotozoals (Nitazoxanide). The notification was signed by NIKHIL GAJRAJ, Jt. Secy.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-26092025-266438 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 4220] NEW DELHI, TUESDAY, SEPTEMBER 23, 2025/ASVINA 1, 1947 6359 GI/2025 [F. No. X.11035/125/2024-DR] NIKHIL GAJRAJ, Jt. Secy. MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 23rd September, 2025 S.O. 4338(E).—WHEREAS, the Central Government has published a draft notification, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number S.O. 2298 (E), dated the 22nd May, 2025, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (ii), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft notification are made available to the public; AND WHEREAS, copies of the said Official Gazette were made available to the public on the 22nd May, 2025; AND WHEREAS, no objections and suggestions were received from the public on the said rules; AND WHEREAS, safer alternatives to the said drugs for animal use 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 any antimicrobial medicinal products for animal use as specified in this notification; Now, therefore in exercise of the powers conferred by sections 10A & 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, the Central Government hereby prohibit the import, manufacture, sale and distribution of the following antimicrobials and group of such antimicrobials and their formulations for animal use namely: - 1. Antibiotics i. Ureidopenicillins ii. Ceftobiprole iii. Ceftaroline iv. Siderophore cephalosporins v. Carbapenems vi. Penems vii. Monobactams viii. Glycopeptides ix. Lipopeptides x. Oxazolidinones xi. Fidaxomicin xii. Plazomicin xiii. Glycylcyclines xiv. Eravacycline xv. Omadacycline 2. Antivirals i. Amantadine ii. Baloxavir marboxil iii. Celgosivir iv. Favipiravir v. Galidesivir vi. Lactimidomycin vii. Laninamivir viii. Methisazone/ Metisazone ix. Molnupiravir x. Nitazoxanide xi. Oseltamivir xii. Peramivir xiii. Ribavirin xiv. Rimantadine xv. Tizoxanide xvi. Triazavirin xvii. Umifenovir xviii. Zanamivir 3. Antiprotozoals Nitazoxanide [F. No. X.11035/125/2024-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. GORAKHA NATH YADAVA

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