India Proposes Ban on Antimicrobial Drugs for Animal Use to Mitigate Human Risk

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Dated: 03.06.2025

India Proposes Ban on Antimicrobial Drugs for Animal Use to Mitigate Human Risk

The Ministry of Health and Family Welfare, Government of India, issued Draft Notification S.O. 2298(E) under Section 26A of the Drugs and Cosmetics Act, 1940, proposing a prohibition on the import, manufacture, sale, and distribution of certain antimicrobial formulations for animal use in India.

This move comes amid increasing global concerns around antimicrobial resistance (AMR) and its severe implications for human health.

Why the Ban?

The Central Government has found that:

The use of antimicrobials in animals can pose significant risks to human health.
Safer alternatives for animal use are already available.
Continued misuse of such drugs may lead to the development of resistant strains, making human infections difficult to treat.

Key Provisions of the Draft Notification

Issued under Section 26A of the Drugs and Cosmetics Act, 1940
Proposes to ban import, manufacture, sale, and distribution for animal use
Targets a wide list of antibiotics, antivirals, and antiprotozoals
Applies to drugs either in single formulation or combinations

Categories of Drugs Proposed to be Prohibited for Animal Use

1. Antibiotics

Includes:

Ureidopenicillins
Ceftobiprole, Ceftaroline
Carbapenems, Monobactams
Glycopeptides, Lipopeptides
Oxazolidinones (e.g., Linezolid)
Fidaxomicin, Plazomicin
Glycylcyclines (e.g., Tigecycline)
Eravacycline, Omadacycline

2. Antivirals

Includes:

Amantadine, Baloxavir Marboxil
Favipiravir, Galidesivir
Molnupiravir, Oseltamivir, Ribavirin
Nitazoxanide, Zanamivir
Umifenovir, Peramivir

3. Antiprotozoals

Nitazoxanide (listed under both antivirals and antiprotozoals)

Public Feedback Timeline

The draft is open for public comments for 30 days from its publication date.
Stakeholders can send objections/suggestions to the Under Secretary (Drugs), Ministry of Health, either by post or email at:
drugsdiv-mohfw@gov.in

Context & Global Implications

India’s draft notification is aligned with:

WHO guidelines on curbing the use of medically important antimicrobials in livestock.
One Health framework, which links human, animal, and environmental health.
National action plans to address the AMR crisis, which is forecasted to become a leading cause of mortality by 2050 if left unchecked.

Conclusion

The Draft Notification S.O. 2298(E) represents a bold and proactive step by the Indian government to curb the irrational use of antimicrobials in animals, aiming to protect public health from rising antimicrobial resistance. All stakeholders in the pharma, veterinary, and food supply chains should take immediate note and prepare for impending compliance requirements.

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Source: CDSCO

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