Govt Flags Abhayrab Rabies Vaccine Batch as Substandard, Probes if Spurious, Document Shows
A federal laboratory found the sample failed potency tests and showed labeling and packaging differences, prompting a probe into whether it is spurious.
- On September 4, India's drug regulator flagged Abhayrab batch KE25012 as substandard and potentially spurious after it failed a potency test. Drugs Controller General Rajeev Singh Raghuvanshi ordered "strict vigilance" over the batch on August 27.
- The government's Central Drugs Laboratory in Kasauli classified the vaccine as "not of standard quality" and "misbranded," citing discrepancies in labelling, QR code verification, cap colour, and packaging text.
- Indian Immunologicals Ltd maintains a 40% share of India's domestic rabies vaccine market and has supplied more than 210 million doses globally, serving as critical defence where an estimated 5,726 rabies deaths occur annually.
- This incident marks the second time in less than two years that counterfeit concerns have surfaced; Indian Immunologicals previously reported fake batch KA24014 in January 2025, triggering alerts in the United States, Britain, and Australia.
- Official documents do not confirm whether the flagged batch reached international markets or whether foreign regulators were notified. Indian Immunologicals and the federal regulator have not responded to multiple requests for comment.
15 Articles
15 Articles
Drug regulator cracks down after misbranded Abhayrab rabies vaccine seized in Delhi
A seized batch of Abhayrab rabies vaccine from an unlicensed Delhi premises was found misbranded and substandard. The finding has triggered tighter nationwide surveillance and legal action against unauthorised drug networks.
Abhayrab Rabies Vaccine Batch Flagged as Substandard in Delhi; Maker Denies Authenticity | 📰 LatestLY
Vials of the Abhayrab rabies vaccine from batch KE25012, seized in Delhi, have been declared substandard by the Central Drugs Laboratory after failing potency tests. The manufacturer stated the items were counterfeit and not its product, prompting nationwide regulatory alerts and ongoing investigations into illicit distribution networks. 📰 Abhayrab Rabies Vaccine Batch Flagged as Substandard in Delhi; Maker Denies Authenticity.
The Economic Times
Times of IndiaGovt flags Abhayrab rabies vaccine batch as substandard, probes if spurious, document shows
India's drug regulator has flagged a batch of Abhayrab rabies vaccine as substandard. This finding marks the second time concerns have been raised about counterfeit Abhayrab doses. The government's Central Drugs Laboratory found the vaccine did not meet potency requirements. Significant differences were noted between the sampled product and a reference sample. The regulator is investigating whether the vaccine is spurious under Indian law.
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