India to Centralize Testing of 42 Veterinary Vaccines Under Regulatory Overhaul
India is embarking on a major regulatory transformation in the veterinary sector, with plans to centralize testing and quality control for 42 essential veterinary vaccines at a single national laboratory. This move replaces a fragmented system that currently allows self-certification by manufacturers and state-level testing, according to government officials and documents reviewed by media outlets.
From Fragmented System to Centralized Oversight
The current system for veterinary vaccine testing in India has been characterized by significant fragmentation. Manufacturers often self-certify their batches or rely on various state and regional laboratories, leading to potential inconsistencies in quality standards across different regions.
The proposed amendment, issued as a draft notification on 28 January 2026, will be finalized after a 30-day public consultation period. This regulatory shift comes as India grapples with recurring zoonotic outbreaks including Nipah virus, avian influenza, rabies, and zoonotic tuberculosis, alongside rising demand for animal-derived protein.
Designated Apex Laboratory
The Baghpat-based Chaudhary Charan Singh National Institute of Animal Health (CCSNIAH) will be designated as the exclusive apex laboratory for batch release and quality assessment of these biological products. The institute will begin safety and efficacy testing of the 42 viral and bacterial vaccines this month.
"By vesting batch-release and quality-control functions for this entire basket of 42 vaccines in a single apex institute (CCSNIAH), the government aims to standardize testing as per Indian Pharmacopoeia norms, remove regional inconsistencies, and create a clear accountability point for safety and efficacy," a spokesperson for the Department of Animal Husbandry and Dairying said in an official statement.
Vaccines Covered Under New System
The 42 vaccines span livestock, poultry, and companion animals, including:
- Blackquarter and Haemorrhagic Septicaemia vaccines for cattle and buffalo
- Brucella Abortus (Strain 19) vaccine
- Ranikhet and Marek's Disease vaccines for poultry
- Peste des Petits Ruminants vaccine for goats and sheep
- Theileriosis vaccine for cattle
- Common pet vaccines including Canine Distemper and Canine Parvovirus
The overhaul aims to standardize testing under Indian Pharmacopoeia (IP) rules, which are legally enforceable standards defining a drug's identity, purity, and strength.
Market Impact and Industry Response
India's veterinary vaccine market was valued at approximately ₹3,000 crore ($250 million) in 2024 and is projected to grow to over $330 million by 2030, according to industry estimates. Domestic production is led by companies including Indian Immunologicals Ltd. (IIL), Hester Biosciences, and Zydus Animal Health.
"With the Indian veterinary vaccine market now estimated at approximately ₹3,000 crore, such regulatory updates are vital to ensuring that supply keeps pace with the country's surging demand for livestock health products," said Dr. K. Anand Kumar, managing director of Indian Immunologicals Ltd and vice president of a newly formed veterinary vaccine manufacturers' association.
While centralization is expected to improve quality oversight, industry executives have cautioned that concentrating batch testing in a single laboratory could potentially slow product release timelines. They noted that the Indian Veterinary Research Institute (IVRI) could play a supporting role to prevent bottlenecks.
Animal Population Context
India has 535.78 million livestock animals, according to the 20th Livestock Census (2019), and a pet population of about 35 million based on 2023–24 projections from Invest India and the Department of Animal Husbandry and Dairying.
"Standardized testing at a national hub ensures that vaccines are not only safe but possess the required potency to prevent widespread outbreaks," one government official explained. "The government intends to eliminate regional inconsistencies in testing and provide a more reliable safety net for the country's massive livestock and poultry sectors."
Officials emphasized that centralized testing would help ensure vaccines possess adequate potency to prevent outbreaks across India's extensive livestock and poultry sectors, which are crucial to the nation's food security and agricultural economy.
