An Abhayrab rabies vaccine batch has been flagged as substandard and potentially spurious by India’s drug regulator, after a government laboratory found that a field sample failed to meet potency requirements, according to an official document seen by Reuters. The finding, disclosed on September 4, marks the second time in under two years that questions have been raised over the authenticity of doses sold under the Abhayrab brand, one of the country’s most widely used defences against a disease that is almost always fatal once symptoms appear.
India’s Drugs Controller General, Rajeev Singh Raghuvanshi, wrote to state drug regulators on August 27, instructing them to maintain strict vigilance over the movement and distribution of the affected batch, identified as KE25012, and to take regulatory action as necessary. The instruction followed testing at the government’s Central Drugs Laboratory in Kasauli, which classified the sample as “not of standard quality” and as a misbranded drug.
Spurious Drug Investigation Opens Over Packaging and Potency Discrepancies
The spurious drug investigation was triggered after laboratory analysts compared the field sample against a retained reference sample of the same vaccine, previously submitted by a division of Indian Immunologicals for regulatory testing. While the batch passed sterility, moisture and identity tests, it failed on potency, the measure of a vaccine’s ability to trigger an adequate immune response. Investigators also identified a series of discrepancies between the two samples, including differences in labelling, artwork, QR code verification, cap colour, licence details and packaging text.
Regulators said these inconsistencies raised concerns about the sample’s identity and authenticity, warranting further inquiry into whether the batch could constitute a spurious drug under India’s Drugs and Cosmetics Act. Neither Indian Immunologicals nor the federal drug regulator responded to multiple requests for comment on the findings. The government document reviewed by Reuters does not specify how many doses from the flagged batch may have already been distributed, nor whether any were exported or whether foreign regulators have been informed of the latest development.
Counterfeit Rabies Vaccine Concerns Have Surfaced Before
Concerns over a counterfeit rabies vaccine circulating under the Abhayrab name are not new. Indian Immunologicals had previously alerted the drug regulator in January 2025 after counterfeit doses bearing batch number KA24014 were discovered in the market. That earlier episode prompted health authorities in the United States, Britain and Australia to issue advisories for travellers who may have received the vaccine while in India, with several agencies recommending replacement doses as a precaution. At the time, the company maintained that it had not manufactured the counterfeit batch, described the incident as isolated, and said it was unaware of any other counterfeit doses in circulation.
The recurrence of such concerns underscores the stakes involved. India records an estimated 5,726 human rabies deaths annually, according to a 2024 study by the National Institute of Epidemiology, part of the Indian Council of Medical Research. The country accounts for a substantial share of the world’s rabies burden, and vaccines such as Abhayrab serve as the primary line of defence for individuals exposed to the virus, typically through animal bites.
Indian Immunologicals Limited and the Scale of Distribution
Indian Immunologicals Limited, the manufacturer behind Abhayrab, has supplied more than 210 million doses of the vaccine across India and other countries over more than two decades, holding roughly 40 percent of the domestic rabies vaccine market as of December. Abhayrab is administered for both pre-exposure and post-exposure protection against rabies, typically across multiple doses, and is also distributed through government immunisation programmes within India.
Beyond its domestic footprint, the company exports Abhayrab to more than 40 countries, including South Africa, Turkey, Vietnam, Cambodia, Zimbabwe, Thailand and the United Arab Emirates. This scale of distribution means that any confirmed quality lapse, whether the result of manufacturing failure or deliberate counterfeiting, carries implications well beyond India’s borders.
What Happens Next
The instruction to state drug regulators to maintain vigilance over the Abhayrab rabies vaccine batch suggests that Indian authorities are treating the matter with urgency, even as the precise scale and cause of the discrepancy remain under investigation. Whether the substandard classification stems from a manufacturing lapse at Indian Immunologicals or from the deliberate introduction of counterfeit product into the supply chain, as occurred in the 2025 episode, has yet to be established.
Given the vaccine’s role as a frontline treatment against a disease with a near-total fatality rate once symptoms develop, regulators and public health officials are likely to face pressure to clarify the scope of the affected batch and confirm whether any doses reached patients before the quality failure was detected. For now, the government document offers no indication of how many doses were distributed or whether the flagged batch travelled beyond India’s domestic market, leaving open questions that health authorities at home and abroad will be watching closely.
Published in SouthAsianDesk, September 5th, 2026
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