India’s drug regulator flags rabies vaccine batch as substandard, raising fake dose fears: Report

A batch of India’s widely used rabies vaccine Abhayrab has been flagged as substandard and potentially spurious after failing a potency test, according to a government document reviewed by Reuters. The finding has raised fresh concerns over the quality and authenticity of critical vaccines distributed across the country.

As per the report, India’s Drugs Controller General, Rajeev Singh Raghuvanshi, instructed state drug regulators in an August 27 letter to maintain strict vigilance over the movement and distribution of Abhayrab batch KE25012, advising regulatory action where necessary.

The directive followed tests by the government’s Central Drugs Laboratory in Kasauli, which found that a field sample failed potency requirements. The laboratory classified the sample as "not of standard quality" and labeled it a "misbranded" drug, according to the document cited by Reuters.

Business Today was unable to verify the development independently.

Packaging and authenticity concerns 

While the field sample passed sterility, moisture, and identity tests, laboratory officials discovered major discrepancies when comparing it against a retained reference sample submitted earlier by a division of Indian Immunologicals.

Differences were identified in labeling, artwork, QR-code verification, cap color, license details, and packaging text. The variations raised concerns about product identity and prompted authorities to investigate whether the sample constitutes a spurious drug under India’s Drugs and Cosmetics Act.

Second counterfeit scare in 2 years 

The alert marks the second time in under two years that suspect Abhayrab doses have surfaced in India. In January 2025, Indian Immunologicals alerted the drug regulator that counterfeit doses bearing batch number KA24014 were circulating in the market.

Health authorities in the United States, Britain, and Australia later issued alerts for travelers who may have received the vaccine in India. Indian Immunologicals stated at the time that it had not manufactured the fake batch and characterized the incident as isolated.

Abhayrab’s role in rabies protection 

Indian Immunologicals has supplied over 210 million doses of Abhayrab domestically and internationally over more than two decades, holding approximately 40% of India’s rabies vaccine market. The vaccine is supplied to government immunization programs for both pre- and post-exposure rabies protection. India records an estimated 5,726 human rabies deaths annually.

The government document did not outline how many doses of batch KE25012 were distributed. It remains unclear if any doses from the batch were exported or if international regulators have been notified. Indian Immunologicals exports Abhayrab to more than 40 countries, including South Africa, Turkey, Vietnam, Cambodia, Zimbabwe, Thailand, and the United Arab Emirates.