India’s drug regulator has traced a batch of the anti-rabies vaccine Abhayrab, which it flagged as misbranded and not of standard quality after it failed a potency test, to an unlicensed flat in north Delhi from where police seized the vials in April, the Central Drugs Standard Control Organisation said on Saturday.
Abhayrab batch seized during Delhi Police raid
Four people have been arrested in the case. The seizure is the second time in less than two years that counterfeit Abhayrab doses have surfaced in India. The regulator’s public notice sets out for the first time where the doses of batch KE25012 came from. The vials were sent for testing, and the Central Drugs Laboratory (CDL) in Kasauli found it failed the potency test, which measures whether a vaccine carries enough antigen to raise protective immunity. Human Biologicals Institute, in Telangana, is the IIL division that makes the vaccine. The laboratory’s comparison lists those differences. Seized vials had blue caps against the green caps on the retained samples, and carried a hologram on the seal where the reference vials had none. The QR code on the seized pack could not be verified by GS1, the global barcode standards body. Posteur”. The rest of the list covers fonts, text alignment, logo colour, the wording of the warning box and the size of the registered trademark symbol.
On August 27, Drugs Controller General of India Rajeev Singh Raghuvanshi asked state drug controllers to alert their inspectorate staff and maintain strict vigilance over the movement, distribution and availability of the batch, a communication first reported by Reuters on Thursday. On April 22, the Crime Branch of Delhi Police, along with drugs inspectors raided a flat in Mukherjee Nagar, and seized vials of the vaccine, the notice said. The test results also recorded that the vials, labelled for storage between 2°C and 8°C, were being kept at room temperature when the sample was collected. “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. The name of Louis Pasteur, whose 2061 vaccine strain is used in the product, was misspelt as “L. The preservative concentration was printed as a weight-by-weight figure instead of weight-by-volume, the artwork number was PLM0395/07/22 against PLM0395/08/24 on the reference pack, and the diluent manufacturing licence number was DD/449 instead of 30/MD/AP/2013/F/G.
The regulator said no part of the batch was exported to any other country. Indian Immunologicals Ltd (IIL), which sells Abhayrab, said in a statement that the samples were drawn during an enforcement action at an unlicensed residential premises in Delhi. On that basis, the vials examined are not a product manufactured by Human Biologicals Institute,” the company said.
