DistantNews
Support us
🇦🇪 United Arab Emirates /Health & Science

India flags Abhayrab rabies vaccine batch as substandard and potentially fake

From Khaleej 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 rabies vaccine batch KE25012 as not of standard quality and potentially spurious after it failed a potency test.
  • Laboratory checks found differences in labeling, artwork, QR-code verification, cap color, license details, and packaging text compared with a retained reference sample.
  • The regulator urged state authorities to monitor the batch and take action as needed; the document does not say how many doses may be affected.

India’s drug regulator has raised concerns about a batch of the widely used Abhayrab rabies vaccine after it failed a potency test and appeared potentially fake. The finding marks the second warning in less than two years involving suspected counterfeit Abhayrab doses in India, where rabies causes thousands of deaths annually.

In an August 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 letter followed testing by the government’s Central Drugs Laboratory in Kasauli.

strict vigilance

· Rajeev Singh RaghuvanshiThe drugs controller directed state regulators to monitor the movement and distribution of the flagged batch.

The laboratory classified the field sample as “not of standard quality” and as a “misbranded” drug. Although it passed sterility, moisture, and identity tests, the sample differed significantly from a retained reference sample previously submitted by a division of Indian Immunologicals for regulatory testing.

not of standard quality

· Central Drugs Laboratory in KasauliThe laboratory’s classification followed the failed potency test.

The differences included the label, artwork, QR-code verification, cap color, license details, and wording on the packaging. The regulator said those findings raised concerns about the sample’s “identity and authenticity” and warranted an investigation into whether it was a spurious drug under India’s Drugs and Cosmetics Act.

Indian Immunologicals has supplied more than 210 million Abhayrab doses in India and other countries over more than two decades. The company said in December that it held 40% of India’s domestic rabies-vaccine market. Neither the company nor the federal regulator responded to multiple requests for comment.

misbranded

· Central Drugs Laboratory in KasauliThe laboratory used this classification for the tested vaccine sample.

The company had notified the regulator in January 2025 about counterfeit Abhayrab doses carrying batch number KA24014. Health authorities in the United States, Britain, and Australia later warned travelers who may have received the vaccine in India. Indian Immunologicals said at the time that it had not made that counterfeit batch, called the incident isolated, and said it knew of no other counterfeit doses. The government document does not state how many doses from the batch now under investigation may be affected.

identity and authenticity

· India’s drug regulatorThe regulator cited discrepancies between the tested sample and the retained reference sample.
About this summary

Originally published by Khaleej 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.

More Stories

From Our Blog