India Flags Abhayrab Rabies Vaccine Batch as Substandard
India’s drug regulator has flagged a batch of the widely used Abhayrab rabies vaccine as substandard and potentially spurious after a government laboratory found that it failed a potency test. The Drugs Controller General has asked state regulators to maintain strict vigilance over the distribution of batch KE25012 and take necessary regulatory action.
The Central Drugs Laboratory in Kasauli found that the sample failed to meet potency requirements, although it passed sterility, moisture and identity tests. Officials also found differences between the sampled vaccine and a retained reference sample, including discrepancies in labelling, artwork, QR-code verification, cap colour, licence details and packaging text. The findings have prompted an investigation into the batch’s identity and authenticity.
The latest alert comes after counterfeit Abhayrab doses were reported in India in January 2025, leading health authorities in several countries to issue warnings to travellers. Abhayrab is used for both pre- and post-exposure protection against rabies, which remains a major public health concern in India. The government document does not specify how many doses from the flagged batch may have been distributed or whether any were exported.
Pic courtesy: google/ images are subject to copyright
