NEW DELHI: Vials labelled as Abhayrab, a rabies vaccine, found at an unlicensed residential premises in Mukherjee Nagar have been declared “Not of Standard Quality” and misbranded by the Central Drugs Laboratory, Kasauli, with the manufacturer saying the tested vials were not its product.The vials carried batch number KE25012 and were sampled by the Central Drugs Standard Control Organisation (CDSCO) during an enforcement action and sent to the laboratory for testing. The laboratory report recorded 17 differences between the tested vial and the retention samples of the same batch submitted by Human Biologicals Institute, a division of Indian Immunologicals Ltd, for batch-release testing.The sample failed the potency requirement, though it passed sterility, moisture and identity tests. Differences were also found in labelling, artwork, QR-code verification, cap colour, licence details and packaging text. Indian Immunologicals said the vials examined were not manufactured by Human Biologicals Institute.The company said the genuine KE25012 batch had been tested and released by the Central Drugs Laboratory under a batch-release certificate dated November 7, 2025. The 83,370 vials released from the batch were supplied only through its authorised distribution channel, it said, adding that no market complaint had been received for the batch.The development is significant because a spurious or substandard rabies vaccine may fail to provide the protection expected after an animal bite. Rabies is almost invariably fatal once clinical symptoms develop, making effective post-exposure vaccination critical.The Delhi location is significant against the backdrop of a Crime Branch raid in Mukherjee Nagar earlier this year, in which 953 rabies vaccine vials were among medicines recovered in an alleged spurious-drug racket. Four people were arrested. However, there is currently no evidence establishing that those seized vials were from batch KE25012.The latest finding also comes less than two years after Indian Immunologicals informed the drug regulator in January 2025 about counterfeit Abhayrab doses carrying batch number KA24014. Health authorities in the US, UK and Australia subsequently issued alerts for people who may have received the vaccine in India.
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Indian Immunologicals said it submitted its manufacturing, quality-control, reconciliation and distribution records to CDSCO on August 14. In its September 4 representation to the Drugs Controller General of India, it asked authorities to trace the source of the vials and act against those responsible.The company said every Abhayrab batch is independently tested and released by the Central Drugs Laboratory before sale. Vaccines supplied through hospitals, clinics, government facilities and licensed pharmacies via its authorised distribution chain, it said, are not affected by the matter.
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