India’s drug regulator traces substandard Abhayrab rabies vaccine to Delhi flat

India’s drug regulator has traced a batch of Abhayrab rabies vaccine to an unlicensed flat in north Delhi, where police seized the vials during a raid in April. Four people have been arrested in the case.

The Central Drugs Standard Control Organisation said the batch, identified as KE25012, was misbranded and failed a potency test. The test measures whether a vaccine contains enough antigen to produce protective immunity. The Central Drugs Laboratory in Kasauli examined the seized vials after the April 22 raid by Delhi Police’s Crime Branch and drug inspectors.

The regulator also said the vaccine, labelled for storage at between 2°C and 8°C, was kept at room temperature when the sample was collected. It said no part of the batch had been exported to another country. The seizure marks the second time in less than two years that counterfeit Abhayrab doses have surfaced in India.

Indian Immunologicals, which sells Abhayrab, said the samples came from an enforcement action at an unlicensed residential premises. The company said the laboratory report recorded 17 differences between the seized vial and retention samples from the same batch, which it had submitted for batch release. It said the examined vials were not made by Human Biologicals Institute, its vaccine-manufacturing division in Telangana.

The differences included blue caps instead of green ones, a hologram on the seal, an unverifiable QR code and a misspelling of Louis Pasteur’s name as “L. Posteur.” The seized packaging also used different artwork and printed the preservative concentration using weight by weight rather than weight by volume.

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The same laboratory report records (17) seventeen differences between that vial and the retention samples of the same batch held at the laboratory, which we had submitted for batch release. On that basis, the vials examined are not a product manufactured by Human Biologicals Institute.