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Core Purpose

Draft notification is published under Section 26A of the Drugs and Cosmetics Act, 1940, proposing to prohibit the import, manufacture, sale, and distribution of specific antimicrobial medicinal products for animal use.

Detailed Summary

The Central Government, satisfied that the use of certain antimicrobial formulations in animals poses a risk to humans and that safer alternatives exist, has published a draft notification under section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940). This draft notification, S.O. 2298(E), dated New Delhi, the 22nd May, 2025, proposes to prohibit the import, manufacture, sale, and distribution of listed antimicrobial medicinal products for animal use. The draft was published after consultation with the Drugs Technical Advisory Board for the information of affected persons. Notice is given that the draft will be considered after thirty days from its publication in the Gazette of India. Objections and suggestions from any person within this period will be considered by the Central Government and can be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545 A Wing, Nirman Bhavan, New Delhi -110011 or emailed at drugsdivmohfw@gov.in. The notification lists specific Antibiotics, Antivirals, and Antiprotozoals proposed for prohibition.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-23052025-263340 EXTRAORDINARY PART II-Section 3-Sub-section (ii) PUBLISHED BY AUTHORITY No. 2244] NEW DELHI, THURSDAY, MAY 22, 2025/JYAISTHA 1, 1947 3373 GI/2025 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 22nd May, 2025 S.O. 2298(E). - Whereas, the Central Government is satisfied that the use of drugs formulations containing any antimicrobials or group of antimicrobials and their formulations as listed below in animals are likely to involve risk to Humans. 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 as listed below for animal use; Now, therefore in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the draft notification is hereby published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is hereby given that the said draft notification shall be taken into consideration on or after 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. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 545 A Wing, Nirman Bhavan, New Delhi -110011 or emailed at drugsdivmohfw@gov.in. Following antimicrobials and group of antimicrobials and their formulations for animal use: - 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 i. Nitazoxanide [F. No. X.11035/125/2024-DR] RAJIV WADHAWAN, Adviser (Cost)

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