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Health ministry issues draft notification to ban use of 34 antimicrobials in animals
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Gireesh Babu, New Delhi
May 27 , 2025
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The Union health ministry has issued a draft notification to ban import, manufacture and sale of 34 antimicrobials and their formulations for animal use, following a recommendation from the Drugs Technical Advisory Board (DTAB). The prohibition is in line with similar action from countries in the European Union, among others.
The Ministry has issued the draft notification on May 22, issuing notice to the stakeholders that the draft will be taken into consideration on or after a period of 30 days from the date of its publication in the Official Gazette. It also said that objections and suggestions received from any person within this period will be considered by the Central government.
The list of drugs proposed to be banned for animal use include 15 antibiotics including ureidopenicillins, ceftobiprole, ceftaroline, siderophore cephalosporins, carbapenems, penems, monobactams, glycopeptides, lipoptides, oxazolidinones, fidaxomicin, plazomicin, eravacycline,and omadacycline.
A list of 18 antivirals including amantadine, baloxavir marboxil, favipiravir, galidesivir, lactimodomycin, laninamivir, methisazone, molnupiravir, oseltamivir, ribavirin, among others are also part of the notification. Besides, antiprotozoal drug nitazoxanide has also been listed in the notification for the proposed ban.
The Ministry said that the Central government is satisfied that the use of drugs formulations containing any antimicrobials or group of antimicrobials and their formulations on the list, in animals are likely to involve risk to humans. There are safer alternatives to these drugs for animal use available in the market, it added.
As reported earlier, the DTAB in its recent meeting, has recommended prohibition of 34 antimicrobial medicinal products listed by the European Union as reserved for treatment of certain infections in humans only, from animal use.
While the Commission Implementing Regulation (EU) in the year 2022 has listed a total of 37 antimicrobials as to be used only in humans, the Board recommended that the Department of Animal Husbandry and Dairying (DAHD) should submit report on the other three antimicrobials at the earliest, for appropriate decision.
The Board was considering a proposal related to prohibition of manufacturing, import, sale and distribution of 37 antimicrobials medicinal products (as laid down in the Commission Implementing Regulation (EU) 2022/1255 for Growth purpose or yield increase in the food producing animals, while these products are reserved for treatment of certain infections in Humans.
Considering the proposal, it said, "Board also noted that though these 37 antimicrobials have not been approved by CDSCO (Central Drugs Standard Control Organisation) for veterinary use in treatment of various diseases, however these may be notified for prohibition in light of the request received from the ministry of commerce."
The representative from DAHD also explained the background on the issue and informed the Board that it has no objection for reserving 34 antimicrobials only for human use.
Following this, the DTAB recommended, "to prohibit manufacture, import, sale, distribution and use of 34 antimicrobials medicinal products as laid in EU regulation 2022/1255 except 3 antimicrobials viz carboxypenicillins, combinations of cephalosporins with beta-lactamase inhibitors and phosphonic acid derivatives only, for animal use."
"DAHD shall submit the report about these three antimicrobials at the earliest by providing the clear recommendations, which may be placed before the chairman, DTAB for appropriate decision," it added in the 92nd meeting of the Board, held on April 24, 2025.
"Certain antimicrobial medicinal products or groups of antimicrobial medicinal products should be reserved for treatment of certain infections in humans, with a view to better preserve their efficacy for human medicine and to supporting the fight against antimicrobial resistance, which is a major threat to global health," said the Commission Implementing Regulation (EU) 2022/1255 while listing the drugs.
The regulation by the European Union is also in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, referred to in the regulations of the EU.
The Union ministry of health in the end of the year 2024, has banned manufacturing and sale of non-steroidal anti-inflammatory drug (NSAID) nimesulide and its formulation for animal use, finding it likely to involve risk to animals.
Notifying the ban, the Ministry said that the Central government is satisfied that it is necessary and expedient in the public interest to prohibit all formulations of nimesulide for animal use. There are safer alternatives to this drug available in the market, it added.
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