Rabies vaccine row: CDSCO flags seized Abhayrab batch was misbranded, 4 arrested after media report

Drug regulatory and law enforcement agencies have intensified action against the illegal manufacture and distribution of misbranded drugs after a seized batch of rabies vaccine Abhayrab was found to be misbranded and not of standard quality, according to the Central Drugs Standard Control Organisation.

Four people have been arrested by the Delhi Police in connection with the case, while further investigation and legal action are underway.

The vaccine, Abhayrab, batch number KE25012, was seized on April 22 from an unlicensed premises in Mukherjee Nagar, Delhi, during a joint search by the Delhi Police Crime Branch and drug inspectors from the Drugs Control Department, Government of the National Capital Territory of Delhi.


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The Central Drugs Standard Control Organisation was called in to collect legal samples, which were subsequently sent to the Central Drugs Laboratory in Kasauli for testing. The government laboratory found the sample to be “Not of Standard Quality” and “Misbranded” under the Drugs and Cosmetics Act.

The laboratory found that the sample failed the potency test, although it passed tests for sterility, moisture, thiomersal and identity. It also found multiple differences between the seized vial and the retained sample of the same batch held by the manufacturer, including differences in packaging artwork, labelling, fonts, logo, QR code, cap colour and hologram.

The drug regulator has also advised further investigation to establish whether the product meets the definition of a spurious drug under Section 17B of the Drugs and Cosmetics Act.

The findings were communicated by the Drugs Controller General of India to states and Union territories. In a communication dated August 27, the regulator asked state drug controllers to alert their inspectorates and maintain strict vigilance over the movement, distribution and availability of batch KE25012 and take regulatory action wherever required.

The development comes after a Reuters report highlighted the regulatory action against the rabies vaccine batch. The report said the Central Drugs Laboratory had found the seized vaccine to have failed its potency test and identified discrepancies in its labelling and packaging.

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Indian Immunologicals Ltd, which manufactures Abhayrab through its Human Biologicals Institute division, has said the seized vials were not manufactured by the company. The company has reaffirmed that every Abhayrab batch is released only after independent testing and batch-release certification by the Central Drugs Laboratory, Kasauli.

The manufacturer has also said that no part of the concerned batch was exported to any other country.

The seizure and subsequent regulatory action form part of ongoing surveillance by drug regulators and law enforcement agencies to detect unauthorised manufacture and distribution of drugs.