Rabies vaccine row's new twist: IIL says ‘not mine’

The Central Drugs Standard Control Organisation (CDSCO) has intensified efforts to combat the illegal production and distribution of substandard drugs following the seizure of a misbranded batch of rabies vaccine, Abhayrab. Four individuals have been arrested by the Delhi Police in connection with the case, and ongoing investigations and legal proceedings are underway.

On April 22, the Abhayrab vaccine batch number KE25012 was seized from an unlicensed location in Mukherjee Nagar, Delhi, as part of a joint operation by the Delhi Police Crime Branch and drug inspectors from the Government of National Capital Territory of Delhi's Drugs Control Department.

The CDSCO was subsequently involved in the collection of legal samples for testing. The government laboratory found the sample to be "Not of Standard Quality" and "Misbranded" under the Drugs and Cosmetics Act. The laboratory's tests revealed that the batch failed the potency test, although it passed tests for sterility, moisture, thiomersal, and identity.

Notably, multiple discrepancies were observed between the seized vial and the retained sample held by the manufacturer, including differences in packaging artwork, labeling, fonts, logo, QR code, cap color, and hologram.

In response to the findings, the drug regulator has advised further investigation to determine if the product qualifies as a spurious drug under Section 17B of the Drugs and Cosmetics Act. The CDSCO has communicated its findings to state and union territory drug controllers, urging them to monitor the movement, distribution, and availability of batch KE25012 closely and take necessary regulatory action.

This development follows a Reuters report detailing the regulatory action taken against the rabies vaccine batch, highlighting the laboratory's discovery of potency test failures and discrepancies in labeling and packaging. Indian Immunologicals Ltd (IIL), the manufacturer of Abhayrab through its Human Biologicals Institute division, has denied involvement in the manufacture of the seized vials, asserting that every Abhayrab batch undergoes independent testing and batch-release certification by the CDSCO in Kasauli. The company has also confirmed that no part of the contested batch was exported to other countries.