India's drug regulator has found that a batch of the widely used rabies vaccine Abhayrab is substandard and potentially counterfeit after failing a potency test, according to a government document reviewed by Reuters.
This discovery marks the second instance in less than two years where concerns have arisen in India regarding counterfeit doses of Abhayrab. Approximately 6,000 deaths from rabies are registered annually in India, and this vaccine serves as the primary defense against this typically fatal infection.
Indian Immunologicals Ltd has supplied over 210 million doses of Abhayrab in India and other countries for more than two decades, holding a 40% share of the domestic rabies vaccine market, as noted in December.
Regulator's Requirements for Batch Distribution
On August 27, in a letter to state drug regulators in India, Rajiv Singh Raguvanshi, Director of Drug Control India, requested officials to maintain 'strict vigilance' during the movement and distribution of the Abhayrab KE25012 batch and to take necessary regulatory measures.
These actions were taken after the Government's Central Drugs Laboratory in Kasuali determined that the field sample of the vaccine did not meet potency requirements, classifying it as 'substandard quality' and a product with 'incorrect labeling,' according to the document.
Although the sample passed tests for sterility, moisture, and identity, the laboratory also found significant discrepancies between the tested product and the stored reference sample of the same vaccine previously submitted by Indian Immunologicals division for regulatory testing. These differences related to labeling, artwork, QR code verification, cap color, license details, and packaging text.
The regulator stated that these findings raised concerns about the 'identity and authenticity' of the sample and necessitated an investigation into whether it could be a counterfeit product under the Indian Drugs and Cosmetics Act. Indian Immunologicals and the federal regulator did not respond to multiple requests for comment.
Previous Traveler Warnings
Previously, Indian Immunologicals notified the Indian drug regulator in January 2025 about the appearance of counterfeit Abhayrab doses with batch number KA24014 on the market. Subsequently, global health authorities in the United States, the United Kingdom, and Australia issued travel advisories for those who might have received this vaccine in India.
At that time, the company stated that it did not manufacture this counterfeit batch, reiterated that the incident was isolated, and reported that it was unaware of any other counterfeit doses in circulation.
According to a 2024 study by the National Institute of Epidemiology of the Indian Council of Medical Research, approximately 5,726 human deaths from rabies are registered annually in India. Abhayrab is a human rabies vaccine used for both pre-exposure and post-exposure prophylaxis. It is administered in multiple doses and is also supplied under government immunization programs in India.
The government document does not specify how many doses from the tested batch may have been distributed, or whether any doses from this flagged batch were exported, nor whether foreign regulators were notified of the latest warning. Indian Immunologicals exports Abhayrab to over 40 countries, including South Africa, Turkey, Vietnam, Cambodia, Zimbabwe, Thailand, and the United Arab Emirates.