CDSCO flags substandard anti-rabies vaccine Abhayrab, traces it to Delhi flat

The Central Drugs Standard Control Organisation (CDSCO) in India has identified a substandard batch of the anti-rabies vaccine Abhayrab, which originated from an unlicensed flat in north Delhi. The vaccine, which failed a potency test, was seized by Delhi Police in April, marking the second time in less than two years that counterfeit Abhayrab doses have been found in the country. Four individuals have been arrested in connection with the case.

The Central Drugs Laboratory (CDL) in Kasauli tested the seized vials and found them to fail the potency test, which measures the amount of antigen needed to raise protective immunity against rabies. The test results also revealed that the vials were being stored at room temperature when the sample was collected, instead of the required 2°C to 8°C range.

Indian Immunologicals Ltd (IIL), the manufacturer of Abhayrab, stated that the samples were taken during an enforcement action at an unlicensed residential premises in Delhi. The company highlighted 17 differences between the seized vials and the retained samples of the same batch held at the laboratory, including discrepancies in labeling, holograms, QR codes, and preservative concentrations.

The seized vials had blue caps and a misspelled name for Louis Pasteur, while the retained samples had green caps and a correctly spelled name. The diluent manufacturing licence number on the seized vials also differed from the reference pack.