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In an effort to control the use of antimicrobials in animals, the Central Drugs Standard Control Organisation (CDSCO) is expected to form a Joint Working Group (JWG) with representatives from CDSCO, Department of Animal Husbandry and Dairying (DAHD), and State drug Licensing Authorities (SLAs) to collect antimicrobial use (AMU) data and monitor at the national level.
The Central drug regulator has also sought its zonal and sub-zonal offices to share a list of approved drugs including antibiotics, fixed dose combinations (FDCs), and their premixes for veterinary use, approved by these offices, to prepare a comprehensive list.
The move to form the JWG is following a proposal from the DAHD, in line with its activities to mitigate the antimicrobial resistance (AMR), especially through the veterinary use of antimicrobial drugs, which in turn affect human health also.
The working group is proposed to serve as a collaborative mechanism to coordinate efforts, and streamline the processes for AMU data collection, reporting, and monitoring at the national level.
In this direction, the DAHD, in a letter to the drug regulator in February, 2025, requested to extend support for the development of a structured AMU reporting framework.
The framework will focus on the systematic collection of data related to the production, sale, and import of antibiotics, as well as information on registered veterinary antimicrobials.
"This initiative is to be undertaken in coordination with the DAHD, SLAs, veterinary pharmaceutical companies, and other relevant stakeholders," said the CDSCO.
The Central drug regulator has sought all State and Union Territory (UT) drug controllers to nominate a nodal officer not below the rank of Assistant Drugs Controller or a senior official from their jurisdiction to act as the point of contact for all matters pertaining to AMU data collection and coordination with the JWG.
It has also sought the state and UT licensing authorities to provide a comprehensive list of veterinary pharmaceutical companies involved in the manufacturing, distribution, and sale of veterinary antibiotics within their jurisdiction. It sought the drug controllers to submit the details at the earliest to enable timely progress of the initiative.
Besides, the Central drug regulator has also sought its zonal and sub-zonal offices to share the details of list of approved drugs including antibiotics, FDCs, and their premixes for veterinary use approved by these offices.
This is for preparation of a comprehensive list required by the regulatory agencies in India and internationally, such as the European Union regulation and World Organisation of Animal Health (WOAH), as well as from other ministries.
The regional offices may share the detail such as the name of the drugs, FDCs, their premixes, which are for veterinary use only, their composition, indications, name and address of manufacturers, date of issuance of license and validity, name and address of the concerned State Licensing Authorities or Food and Drug Authorities (FDAs), among others in a provided format, with the CDSCO, it added.
It may be noted that the drug regulatory authorities and the DAHD has been taking various steps to reduce the impact of antibiotics and antimicrobials in animals including livestock sector, and human beings, in order to curb the menace of antimicrobial resistance (AMR).
CDSCO has in the past also issued various notices/advisories/letters to the state drugs regulators, and other stakeholders for strict compliance of the requirements of Drugs and Cosmetics Act and Rules made thereunder and raising awareness in the public regarding adverse effects of misuse of antibiotics.
The Drugs Technical Advisory Board and the Drugs Consultative Committee in their past meetings have recommended prohibition of manufacturing and sales of various drugs to the livestock sector, especially in the food animals, in order to prevent AMR.
The DAHD has also issued advisories to all states/UTs for judicious use of antibiotics in livestock sector and not to use antibiotics as feed and feed supplements as growth promoter of commercial stocks.
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