Abhayrab rabies vaccine batch flagged as substandard in Delhi

Authorities in Delhi have flagged a batch of Abhayrab rabies vaccine (batch KE25012) as substandard and misbranded. The vials were seized from an unlicensed residential premises in Mukherjee Nagar by the Central Drugs Standard Control Organisation.

Laboratory evaluations by the Central Drugs Laboratory in Kasauli determined that the seized samples failed mandatory potency requirements. While the samples passed tests for sterility, moisture, and identity, they exhibited 17 distinct discrepancies compared to genuine manufacturer samples, including variations in packaging artwork, labeling typography, logos, QR codes, and cap colors.

India Immunologicals (IIL) has denied that the seized vials are authentic products of its subsidiary, Human Biologicals Institute. The company stated that the items are likely counterfeit and has requested authorities to trace their source. IIL confirmed that patients vaccinated with legitimate batches are not affected, as each batch undergoes independent testing and certification before release. The company is cooperating with the investigation and has submitted its manufacturing and distribution records to regulators.