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India strengthens regulations for antibiotic use in food animal production amid export norms & global AMR concerns

India's series of regulatory measures aim to combat AMR threat worldwide, boost trade

Neeraj Kumar, Rajeshwari Sinha

  • India has tightened regulations on antibiotic use in food animal production to address global antimicrobial resistance concerns and comply with EU export norms.

  • The move aims to curb misuse and align with international standards.

  • Most recent prohibition covers 34 antimicrobials for animal use.

Background: Growing threat from antibiotics

The misuse and overuse of antibiotics in food animal production is a known driver for antimicrobial resistance (AMR), which is now considered one of the most serious global health threats. Apart from therapeutic uses, antibiotics also are used for non-therapeutic purposes, such as disease prevention, control and growth promotion.

Antibiotic use in food animal production also has implications on trade / export owing to presence of residual antibiotics in food from animals that are exported such as meat. 

The Government of India has taken significant regulatory steps recently to curb the use of antibiotics in food-producing animals. This comes as part of a broader strategy to address public health risks of antibiotic use in food animal production, and also to strategically align with evolving international trade requirements, particularly those of the European Union (EU).

Context: Regulatory requirements for trade with Europe  

In view of safer public health, EU has applied stringent rules on countries from which they import products of animal origin. The EU Commission has implemented antimicrobial regulations on food animals and related product exports from countries outside the EU. 

The Regulation (EU) 2019/6, for instance, covers all aspects of veterinary medicinal products (VMP), from their development to their use in animals within EU. Through this regulation, EU prohibited the use of antimicrobials as growth promoters or for increasing yield. It also prohibited routine use of antimicrobials to compensate for poor farm conditions (hygiene, management). 

The regulation also talked about reserving the use of certain antimicrobials exclusively for human treatments, which the EU has listed through Regulation (EU) 2022/1255. Overall 37 antimicrobials were reserved, which included 18 antibiotics.

In the context of food animal products imported into the EU, Regulation (EU) 2019/6 requires that antimicrobials have not been used for promoting growth of the animal, and that antimicrobials reserved for the treatment of certain infections in humans as laid down by EU also have not been used. 
In February 2023, the EU commission enforced Regulation (EU) 2023/905, which adds the export controls over the use of antimicrobial medicinal products in animals and animal-derived products exported. It says that products of animal origin from a third country or a region can only enter EU if they have originated from a country that is listed by the EU commission for that purpose.

With regards the application of the prohibition on the use of certain antimicrobial medicinal products in animals, the EU commission in October 2024 established a list of authorised countries through Regulation (EU) 2024/2598 that meet EU requirements and has issued revised model health certificates that include a specific attestation on antimicrobial use. These countries are authorised for the entry into the Union of certain animals and products of animal origin intended for human consumption. The countries not in the list are required to submit declarations and provide appropriate guarantees to avoid any disruption to trade by 3 September 2026.

India along with many other countries is not listed in this. These countries will need to provide evidence of compliance with the prohibition on antimicrobial use. Countries that meet the requirements will be included on the list of authorised exporting countries. Additionally, they must confirm compliance by signing a new, specific attestation for each consignment, which must be attached to the official certificates already required for animal product exports.

Recent developments: India's steps to curb antibiotic misuse in food animal production

India exports a wide range of food animals and animal-based products to countries across Asia, Europe, West Asia, Africa, North America and other countries. Several regulatory actions have been undertaken recently to restrict antibiotic misuse in food-animals. 

In view of the EU Commission requirements, India's Drugs Technical Advisory Board (DTAB) under the Central Drugs Standard Control Organization in its 92nd meeting held in April 2025, discussed the prohibition of 37 antimicrobials that were reserved by EU for use in human treatment.

After deliberations, DTAB recommended to prohibit manufacture, import, sale, distribution and use of 34 out of the 37 antimicrobials laid in EU regulation 2022 / 125.

Three antibiotic classes ─ Carboxypenicillins, Combinations of Cephalosporin’s with beta-lactamase inhibitors and Phosphonic acid derivatives were not prohibited. The Department of Animal Husbandry and Dairying (DAHD) is expected to share report on these three for further appropriate decision on prohibition by DTAB.

Hence, in May 2025, the Union Ministry of Health and Family Welfare (MoHFW) notified the prohibition of the import, manufacture, sale and distribution of 34 antimicrobial medicinal products — 15 antibiotics / groups of antibiotics, 18 antivirals and one antiprotozoal.

Of the 15, there are six antibiotics and nine classes of antibiotics prohibited, all of which are categorised as authorized for human use only, as per the 2024 World Health Organization's List of Medically Important Antimicrobials. 

Interestingly, the prohibition is applicable for animal use and not just food animal production. The measure comes with the understanding that this is necessary and expedient in the public interest, and that safer alternatives to these prohibited antimicrobials are available.

In March 2025, MoHFW prohibited the use of chloramphenicol, nitrofurans, and their formulations. Earlier, in 2019, MoHFW banned the manufacturing, sale, and distribution of colistin and its formulations for use in food-producing animals, including aquaculture. 

In October 2024, the Food Safety and Standards Authority of India (FSSAI) prohibited the use of antibiotics at any stage of production ranging from rearing to final processing in key food sectors such as milk, meat, poultry, eggs, aquaculture and particularly honey. The banned substances include three antibiotic classes such as glycopeptides, nitrofurans, nitroimidazoles, and five antibiotics like carbadox, chloramphenicol, colistin, streptomycin and sulfamethoxazole.

With regard to coastal aquaculture, the Coastal Aquaculture Authority in March 2024 issued a revised notification, replacing its 2005 guideline to tighten antibiotic regulations in coastal aquaculture, which primarily caters to the export market.

This guideline bans five antibiotic classes and five individual antibiotics. Similarly, the Union Ministry of Commerce, in May 2025, banned several medically important antimicrobials in aquaculture (12 antibiotic classes and six individual antibiotics), particularly for products destined for the EU and US markets. These are the same set of antibiotics reserved by EU for human treatments. 

The status of antibiotics prohibited from use in food animal production or animal use by different ministries or organisations are listed below. 

Conclusion

India has introduced regulations on antibiotic use in food animal production to address global antimicrobial resistance concerns and comply with EU export norms. The initiative aims to prevent misuse, align with international standards, and ensure safer food products while maintaining trade relations. India's sustained efforts to contain AMR underscores its commitment to public health and global trade requirements.