New Delhi: India has introduced stricter testing and observation requirements for veterinary medicines, including biological products, with a particular focus on inactivated foot-and-mouth disease vaccines, according to two officials and a document reviewed by Mint.
Under the revised norms, manufacturers must administer a double dose of the vaccine to pigs and observe them for 14 days to detect any adverse reactions or contamination. The rules also introduce the monocyte activation test for biological products to detect pyrogens—substances that can trigger fever and signal contamination—during the manufacturing process.
The changes are part of the 10th edition of the Indian Pharmacopoeia, which came into effect on 1 July. The Indian Pharmacopoeia is the country's official book of quality standards for medicines, vaccines, biological products, and pharmaceutical ingredients.
Implications for vaccine market
The changes have implications for India's roughly $250 million veterinary vaccine market, as the country continues to contend with outbreaks of zoonotic diseases, including Chandipura virus, West Nile virus, avian influenza, covid-19, fungal zoonoses, hantavirus, Lyme disease, melioidosis, mpox, rabies, Nipah virus and zoonotic tuberculosis.
India has 535.78 million livestock animals, including 192.49 million cattle, 148.88 million goats, 109.85 million buffaloes, 74.26 million sheep, and 9.06 million pigs, according to the 20th Livestock Census.
India is also an exporter of veterinary vaccines, with domestic production led by Indian Immunologicals Ltd, Hester Biosciences Ltd, and Zydus Animal Health.
“Based on the scientific inputs, some monographs of the IP 2026 need revisions/amendments for their effective implementation," V. Kalaiselvan, secretary-cum-scientific director of the Indian Pharmacopoeia Commission, stated in a document to all industry stakeholders.
Quality standards for human medicines
The commission has simultaneously revised quality standards for several human medicines, tightening requirements for the detection, identification and control of impurities in commonly used drugs.
For the antiviral drug aciclovir, testing laboratories must now use revised analytical methods to verify reference standards. For the antibiotic clarithromycin, the updated standards tighten impurity limits, requiring that no more than four specified impurities exceed the 0.4% threshold.
The pharmacopoeia also revises quality specifications for the blood pressure medicine azilsartan medoxomil to strengthen control over impurities during manufacturing.
The guidelines also update manufacturing and quality standards for advanced biotechnology products, including hormone therapies and immunomodulators.
For diabetes medicines, the government has provided a transition period for revised dissolution standards covering dapagliflozin and metformin hydrochloride prolonged-release tablets, as well as vildagliptin and metformin prolonged-release tablets. The new requirements will take effect on 1 December 2026.
The revised standards have been circulated to the Drugs Controller General of India, state drug controllers, and industry bodies, including the Indian Drug Manufacturers' Association and the Organisation of Pharmaceutical Producers of India.
Mint queries emailed to the health ministry spokesperson remained unanswered.