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India Flags Abhayrab Rabies Vaccine Batch as Substandard and Investigates Whether It Is Spurious, Document Shows

From Hindustan Times · () English

Translated from English and summarized by DistantNews. Read the original for the full story.

At a glance

Newswire Documents & data Under investigation
  • India’s drug regulator flagged Abhayrab batch KE25012 after a government laboratory found it failed potency requirements.
  • The sample passed sterility, moisture and identity tests but differed from a retained reference sample in labeling, packaging and QR-code verification.
  • The finding prompted an investigation into whether the batch was spurious, months after authorities warned about counterfeit Abhayrab doses.

India’s drug regulator has flagged a batch of the widely used Abhayrab rabies vaccine as substandard and potentially spurious after it failed a potency test, according to a government document reviewed by Reuters.

The Central Drugs Laboratory in Kasauli classified the sample as “not of standard quality” and as a “misbranded” drug. It passed tests for sterility, moisture and identity, but differed significantly from a retained reference sample previously submitted by a division of Indian Immunologicals for regulatory testing.

The differences included the labeling, artwork, QR-code verification, cap color, license details and packaging text. The regulator said the findings raised questions about the sample’s “identity and authenticity” and justified an investigation into whether it could be a spurious drug under India’s Drugs and Cosmetics Act.

strict vigilance

· Rajeev Singh Raghuvanshi, India's Drugs Controller GeneralHe used the phrase in an Aug. 27 letter urging state regulators to monitor the batch’s movement and distribution.

In an Aug. 27 letter to state drug regulators, Drugs Controller General Rajeev Singh Raghuvanshi told officials to maintain “strict vigilance” over the movement and distribution of batch KE25012 and to take regulatory action when necessary.

The alert is the second in less than two years involving concerns about counterfeit Abhayrab doses in India. Indian Immunologicals previously told the regulator in January 2025 that counterfeit doses marked with batch number KA24014 had entered the market. Health authorities in the United States, Britain and Australia later warned travelers who might have received the vaccine in India.

The company has supplied more than 210 million Abhayrab doses in India and other countries over more than two decades. It said in December that it held 40% of India’s domestic rabies vaccine market. Indian Immunologicals and the federal regulator did not respond to requests for comment. India records an estimated 5,726 human rabies deaths annually, according to a 2024 study cited in the report.

identity and authenticity

· India's drug regulatorThe regulator cited these concerns after the sample differed from a retained reference sample.
About this summary

Originally published by Hindustan Times in English. Translated, summarized, and contextualized automatically by DistantNews, with a note on how the source frames the story. Not individually reviewed before publishing. How this works.

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