India's drug regulator has flagged a batch of the Abhayrab rabies vaccine as substandard and potentially spurious after it failed a potency test. The finding marks the second instance in under two years where concerns have arisen regarding counterfeit Abhayrab doses within India.
Drugs Controller General Rajeev Singh Raghuvanshi issued a letter on Aug. 27 to state drug regulators instructing officials to maintain strict vigilance over the movement and distribution of Abhayrab batch KE25012 and to initiate regulatory action.
The Central Drugs Laboratory in Kasauli conducted tests on a field sample of batch KE25012 and determined the vaccine did not meet potency requirements, classifying it as "not of standard quality" and a "misbranded" drug.
While the sample passed sterility, moisture and identity tests, the laboratory identified discrepancies between the sampled product and a reference sample of the same vaccine previously submitted by Indian Immunologicals for regulatory approval. Differences included variations in labeling, artwork, QR code verification, cap color, license details and packaging text.
The regulator said the findings raise concerns about the sample's identity and authenticity, necessitating an investigation into whether the product could be classified as a spurious drug under India's Drugs and Cosmetics Act.
Indian Immunologicals Ltd. has supplied over 210 million doses of Abhayrab in India and other countries over two decades. The company reported in December that it held a 40 percent share of the domestic rabies vaccine market.
Abhayrab is a human rabies vaccine providing protection both before and after exposure to the virus. It is administered in multiple doses and is a key component of government immunization programs throughout India.
India records an estimated 5,726 human rabies deaths annually, according to a 2024 study conducted by the Indian Council of Medical Research's National Institute of Epidemiology. The vaccine is a critical defense against an infection that is nearly always fatal without intervention.
The alert follows a previous incident in January 2025, when Indian Immunologicals notified India's drug regulator about counterfeit Abhayrab doses bearing batch number KA24014 entering the market. Global health authorities in the United States, Britain and Australia issued alerts for travelers who may have received the vaccine in India.
Indian Immunologicals said it had not manufactured batch KA24014 and described the incident as isolated, reporting no awareness of other counterfeit doses in circulation. Neither the company nor the federal regulator provided comments on the latest developments when contacted.
