India To Centralize Testing Of 42 Veterinary Vaccines Under Regulatory Overhaul

(MENAFN- Live Mint)

NEW DELHI: India plans to centralize testing and quality control of 42 essential veterinary vaccines at a single national laboratory, replacing a fragmented system that allows self-certification and state-level testing, according to two government officials and a document reviewed by Mint.

The move, set in motion by the Drugs Technical Advisory Board (DTAB), will designate the Baghpat-based Chaudhary Charan Singh National Institute of Animal Health (CCSNIAH) as the exclusive apex laboratory for batch release and quality assessment of these biological products. The vaccines span livestock, poultry, and companion animals.

The overhaul aims to standardize testing under Indian Pharmacopoeia (IP) rules that are legally enforceable standards defining a drug's identity, purity and strength, and create a single point of accountability for safety and efficacy.

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From self-certification to central oversight

At present, veterinary vaccine manufacturers often self-certify batches or rely on state and regional laboratories. Officials said the proposed amendment seeks to end this system.

The amendment was issued as a draft notification on 28 January 2026 and will be finalized after a 30-day public consultation period, officials said.

“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 emailed response.

“Standardized testing at a national hub ensures that vaccines are not only safe but possess the required potency to prevent widespread outbreaks. 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," one of the two government officials said, requesting anonymity.

Safety and efficacy testing of the 42 viral and bacterial vaccines will begin this month at CCSNIAH, the second official said.

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The 42 vaccines include those targeting Blackquarter and Haemorrhagic Septicaemia in cattle and buffalo; Brucella Abortus (Strain 19); Ranikhet and Marek's Disease in poultry; Peste des Petits Ruminants in goats and sheep; Theileriosis in cattle; and common pet vaccines such as Canine Distemper and Canine Parvovirus.

The regulatory shift comes as India grapples with recurring zoonotic outbreaks, including Nipah virus, avian influenza, rabies and zoonotic tuberculosis, and rising demand for animal-derived protein.

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.

Officials said centralized testing would help ensure vaccines possess adequate potency to prevent outbreaks across India's livestock and poultry sectors.

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Industry impact

India's veterinary vaccine market was valued at about ₹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.

While centralization is expected to improve quality oversight, industry executives cautioned that concentrating batch testing in a single laboratory could slow product release timelines. They noted that the Indian Veterinary Research Institute (IVRI) could play a supporting role to prevent bottlenecks.

“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.

“However, efficiency must be balanced with transparency, timely approvals, and independent oversight. Given India's size and logistical challenges, regional testing centres are needed alongside the apex lab," said Dr Piyush Patel, director, street dog programme, Humane World for Animals India.

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