India Flags Suspected Substandard Rabies Vaccine Batch, Probe Underway
Drug authorities have alerted state regulators after a batch of Abhayrab failed potency testing, while the manufacturer denied producing the seized vials.
NEW DELHI, Sept 5: India’s drug regulator has flagged a batch of the widely used Abhayrab rabies vaccine as substandard and potentially spurious after samples failed a potency test, prompting authorities to investigate the source and distribution of the vials.
The affected product, identified as batch number KE25012, was seized from an unlicensed premises in Delhi. State drug regulators have been advised to monitor the distribution of the suspected batch as the investigation continues.
Indian Immunologicals Ltd (IIL), the manufacturer of Abhayrab, has denied producing the seized vials. The company said the samples contained several discrepancies when compared with its official manufacturing records.
The reported differences included concerns involving labelling, QR codes and the colour of the vial caps, according to documents reviewed in connection with the investigation.
The manufacturer has said that supplies distributed through authorised channels remain unaffected and that it is cooperating with regulatory authorities.
The development has raised concerns over the integrity of rabies vaccines, particularly because timely and effective vaccination remains a critical component of post-exposure treatment following possible contact with a rabid animal.
Authorities are examining whether the seized products are counterfeit or otherwise unlawfully manufactured. Four people have reportedly been arrested in connection with the case.
The latest action follows an earlier alert involving suspected counterfeit Abhayrab in January 2025, making the issue a continuing concern for regulators and healthcare providers.
No market complaints related to the identified batch had been reported at the time of the latest alert. However, authorities have urged vigilance to prevent potentially ineffective products from entering legitimate medical supply chains.
Rabies remains a serious public health concern in India, where timely access to genuine vaccines and appropriate post-exposure care can be critical in preventing fatal infection.
The investigation is expected to establish the origin of the seized vials and determine whether they were falsely labelled, unlawfully manufactured or otherwise introduced into the supply chain.
