Draft notification to prohibit the import, manufacture, sale and distribution of certain antimicrobial products for animal use

## Policy Analysis Report: Restriction on Antimicrobial Use in Animals (May 22, 2025) **1. Executive Summary:** This report analyzes a new policy notification issued by the Ministry of Health and Family Welfare, Government of India, on May 22, 2025. The policy prohibits the import, manufacture, sale, and distribution of specified antimicrobials and their formulations for use in animals. This measure is enacted under Section 26A of the Drugs and Cosmetics Act, 1940, due to concerns that the use of these drugs in animals poses a risk to human health. The policy aims to protect public health by restricting antimicrobial use in animals where safer alternatives are available. The key finding is that the listed antimicrobials in animals are now banned, impacting pharmaceutical companies, veterinarians, and livestock farmers. **2. Introduction:** The purpose of this report is to provide an informative analysis of the Ministry of Health and Family Welfare's notification regarding the prohibition of certain antimicrobials for animal use, based solely on the text of the provided document. This report aims to outline the policy's core objectives, rationale, key provisions, affected stakeholders, and potential impact. **3. Policy Overview:** This is a new policy. * **Core Objective(s):** The core objective, as inferred from the text, is to protect human health by prohibiting the import, manufacture, sale, and distribution of specific antimicrobials and their formulations for animal use, particularly where safer alternatives exist. **4. Background and Rationale:** * **New Policy:** The policy addresses the potential risk to humans associated with the use of certain antimicrobials in animals. The notification states that 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." The policy also notes that safer alternatives are available for animal use, suggesting a shift towards more responsible antimicrobial stewardship. This likely stems from growing concerns about antimicrobial resistance and its potential impact on human health. **5. Key Provisions / Changes:** * **New Policy:** The policy establishes a prohibition on the import, manufacture, sale, and distribution of the antimicrobials and their formulations listed in the notification for animal use. * The antimicrobials and groups of antimicrobials affected by this policy include: * **Antibiotics:** Ureidopenicillins, Ceftobiprole, Ceftaroline, Siderophore cephalosporins, Carbapenems, Penems, Monobactams, Glycopeptides, Lipopeptides, Oxazolidinones, Fidaxomicin, Plazomicin, Glycylcyclines, Eravacycline, Omadacycline. * **Antivirals:** Amantadine, Baloxavir marboxil, Celgosivir, Favipiravir, Galidesivir, Lactimidomycin, Laninamivir, Methisazone Metisazone, Molnupiravir, Nitazoxanide, Oseltamivir, Peramivir, Ribavirin, Rimantadine, Tizoxanide, Triazavirin, Umifenovir, Zanamivir. * **Antiprotozoals:** Nitazoxanide * This policy is enacted under the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940. * The policy was published as a draft notification following consultation with the Drugs Technical Advisory Board, allowing a 30-day period for public comment and suggestions. **6. Target Audience and Stakeholders:** Based on the provided text, the directly affected stakeholders include: * Pharmaceutical companies involved in the import, manufacture, sale, and distribution of the listed antimicrobials for animal use. * Veterinarians who prescribe or administer these drugs to animals. * Livestock farmers and animal owners who rely on these medications for animal health. * The Ministry of Health and Family Welfare, responsible for implementing and enforcing the policy. * The Drugs Technical Advisory Board, which was consulted in the formulation of the policy. **7. Implementation Aspects (Inferred):** * **Responsible agency/bodies:** The Ministry of Health and Family Welfare is the responsible agency. The Under Secretary Drugs, within the Ministry, is the point of contact for objections and suggestions. * **Timelines or procedures:** A 30-day period is provided for public comments and suggestions following the publication of the draft notification. * The policy's implementation will likely involve monitoring and enforcement by drug regulatory authorities to ensure compliance with the import, manufacture, sale, and distribution restrictions. **8. Expected Outcomes / Impact of Changes:** * **New Policy:** The intended outcomes of this policy include: * Reduced risk to human health from antimicrobial resistance potentially stemming from animal use. * Promotion of the use of safer alternatives for treating animal diseases. * More responsible antimicrobial stewardship in the animal health sector. * The potential impact of the policy includes: * Changes in veterinary practices towards alternative treatments. * Potential economic impact on pharmaceutical companies producing the banned drugs. * Possible increases in the cost of animal healthcare if alternative treatments are more expensive. **9. Conclusion:** The Ministry of Health and Family Welfare's notification to prohibit the use of specified antimicrobials in animals is a significant step towards addressing concerns about antimicrobial resistance and protecting public health. The policy, enacted under Section 26A of the Drugs and Cosmetics Act, 1940, will impact pharmaceutical companies, veterinarians, and livestock farmers. While the policy aims to promote responsible antimicrobial stewardship and protect human health, it is crucial to carefully monitor its implementation and address any unintended consequences to ensure the continued health and well-being of animals. Further analysis would be needed to fully understand the availability and efficacy of alternative treatments and to assess the long-term impact of this policy on animal health and the livestock industry.

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