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Exclusive: India flags Abhayrab rabies vaccine batch as substandard and investigates whether it is counterfeit

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 as substandard and potentially spurious after a government laboratory found it failed a potency test, a document reviewed by Reuters shows.
  • The laboratory also found differences in labelling, packaging, QR-code verification and licence details compared with a retained reference sample.
  • The investigation follows an earlier warning over counterfeit Abhayrab doses and comes as India reports an estimated 5,726 rabies deaths annually.

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

In an Aug. 27 letter to state drug regulators, Drugs Controller General Rajeev Singh Raghuvanshi urged officials to maintain "strict vigilance" over the movement and distribution of batch KE25012 and take regulatory action where necessary. The Central Drugs Laboratory in Kasauli classified a field sample as "not of standard quality" and a "misbranded" drug.

strict vigilance

· Rajeev Singh RaghuvanshiThe Drugs Controller General instructed state regulators to closely monitor the movement and distribution of the flagged vaccine batch.

The sample passed tests for sterility, moisture and identity. But the laboratory found significant differences between it and a retained reference sample previously submitted by a division of Indian Immunologicals for regulatory testing. The discrepancies involved labelling, artwork, QR-code verification, cap colour, licence details and packaging text.

not of standard quality

· Central Drugs Laboratory in KasauliThe laboratory's classification of the field sample after it failed the potency test.

The regulator said the findings raised questions about the sample's "identity and authenticity" and warranted an investigation into whether it could be a spurious drug under India's Drugs and Cosmetics Act. Indian Immunologicals and the federal regulator did not respond to multiple requests for comment.

The finding is the second warning in less than two years involving suspected counterfeit Abhayrab doses in India. The company told the regulator in January 2025 that counterfeit doses bearing batch number KA24014 had entered the market. Health authorities in the United States, Britain and Australia later warned travellers who may have received the vaccine in India. Indian Immunologicals said that batch was not manufactured by the company and that it knew of no other counterfeit doses in circulation.

misbranded

· Central Drugs Laboratory in KasauliThe laboratory's description of the sampled vaccine in the government document.

Indian Immunologicals has supplied more than 210 million Abhayrab doses in India and other countries over more than two decades. It said in December that the vaccine held 40% of India's domestic rabies vaccine market. A 2024 study by the Indian Council of Medical Research's National Institute of Epidemiology estimated 5,726 human rabies deaths in India each year. Abhayrab provides pre- and post-exposure protection and is also supplied to government immunization programs.

identity and authenticity

· India's drug regulatorThe regulator cited these concerns when calling for an investigation into whether the product could be spurious.
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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