India’s drug regulator has raised concerns over a batch of the widely used Abhayrab rabies vaccine after a government laboratory found that it failed a potency test and showed signs that could indicate the product was not genuine.
The finding has renewed concerns about the safety and authenticity of Abhayrab, one of the vaccines used to protect people against rabies, a disease that is almost always fatal once symptoms develop. India records an estimated 5,726 human rabies deaths each year, according to a 2024 study by the Indian Council of Medical Research’s National Institute of Epidemiology.
The Drugs Controller General of India, Rajeev Singh Raghuvanshi, issued a letter to state drug regulators on August 27, asking them to maintain “strict vigilance” over the movement and distribution of Abhayrab batch KE25012. Officials were also instructed to take regulatory action where necessary.
The government document reviewed by Reuters said the Central Drugs Laboratory in Kasauli tested a field sample and found that it did not meet the required potency standards. The laboratory classified the product as “not of standard quality” and “misbranded.”
The sample passed tests for sterility, moisture and identity. However, laboratory officials found several differences between the tested vaccine and a retained reference sample previously submitted by a division of Indian Immunologicals Ltd for regulatory testing.
The differences included the labelling, artwork, QR code verification, cap colour, licence information and wording on the packaging. According to the regulator, these discrepancies raised questions about the sample’s “identity and authenticity” and required further investigation into whether the product could be considered a spurious drug under India’s Drugs and Cosmetics Act.
Indian Immunologicals has supplied more than 210 million Abhayrab doses in India and other countries over more than two decades. The company said in December that it held about 40% of India’s domestic rabies vaccine market.
The latest alert follows an earlier counterfeit vaccine case. In January 2025, Indian Immunologicals informed the drug regulator that fake Abhayrab doses carrying batch number KA24014 had entered the Indian market. Health authorities in the United States, Britain and Australia later issued warnings for travellers who may have received the vaccine in India.
At the time, Indian Immunologicals said it had not produced the counterfeit batch and described the incident as isolated.
The government document does not reveal how many doses of batch KE25012 may have reached patients. It also does not say whether any doses were exported or whether overseas regulators have been notified about the latest investigation.
Indian Immunologicals and India’s federal drug regulator did not respond to multiple requests for comment.
