Dr Sivaranjini warns of fake Abhayrab vaccine, urges patients to check KE25012
HYDERABAD: A batch of Abhayrab anti-rabies vaccine bearing number KE25012 has come under regulatory scrutiny after vials seized from an unlicensed premises in Delhi were found to be misbranded and not of standard quality.
The Central Drugs Standard Control Organisation (CDSCO) has alerted state drug regulators to maintain vigilance over the movement and distribution of the batch. The seized vials were collected from an unlicensed premises in Mukherjee Nagar, Delhi, and tested by the Central Drugs Laboratory in Kasauli.
Indian Immunologicals Ltd, which manufactures Abhayrab through its Human Biologicals Institute division, said the seized vials were not its product. The company said laboratory examination found 17 differences between the seized vials and its retained samples of the genuine batch.
The discrepancies reportedly included labelling, artwork, QR-code verification, cap colour, licence details and packaging text. The seized sample also failed the required potency test.
Genuine batch was released on November 7, 2025
Indian Immunologicals said the genuine KE25012 batch had undergone testing and received a batch-release certificate from the Central Drugs Laboratory on November 7, 2025. It said 83,370 vials of the genuine batch were supplied through authorised distribution channels.
The company said it had received no market complaint concerning genuine batch KE25012 and had provided manufacturing, quality-control and distribution records to the regulator.
Pediatrician Dr Sivaranjini has urged people who received Abhayrab batch KE25012, or received Abhayrab on or after November 7, 2025, to contact a healthcare professional if they have concerns about the authenticity of the vaccine.
She advised people to check the vaccine’s QR code and said that if the expected vaccine information does not appear, the vial should be treated as suspicious and medical advice sought.
She also cautioned that anti-rabies vaccine should not be administered in the buttocks and said people who may have received a vaccine by that route should consult a healthcare professional about whether the dose needs to be repeated.
Rabies is almost invariably fatal once clinical symptoms develop, making timely and appropriate post-exposure treatment critical. The Australian Technical Advisory Group on Immunisation has also advised replacement of potentially counterfeit Abhayrab doses with a valid rabies vaccine where authenticity cannot be established.
Dr Sivaranjini further referred to the 10-day observation rule for dogs and cats after a bite or scratch, while cautioning that the rule should not be applied in the same way to exposures involving other mammals.
The latest regulatory action follows an earlier counterfeit Abhayrab alert involving a different batch. Authorities are investigating the source of the KE25012 vials, while four people have been arrested in connection with the Delhi case.
