India's drug regulator has warned state authorities to watch for a batch of Abhayrab rabies vaccine that failed potency testing after vials bearing the batch number KE25012 were seized from an unlicensed residential premises in Delhi.
The Central Drugs Laboratory in Kasauli classified the sample as 'Not of Standard Quality' and 'misbranded' under India's Drugs and Cosmetics Act. The regulator has described the batch as substandard and potentially spurious.
The vials were recovered on April 22 at Mukherjee Nagar, Delhi, during a joint enforcement action by Delhi Police and drug inspectors. Four people were arrested by Delhi Police in connection with the case.
The case carries particular public-health risk because rabies is almost invariably fatal once clinical symptoms develop. A person given a defective vaccine could believe they have received protection when the dose may not meet the required potency.
Laboratory testing found that the seized sample failed the potency requirement. It passed tests for sterility, moisture, thiomersal and identity.
The Central Drugs Laboratory identified 17 differences between the seized vials and genuine retention samples of batch KE25012. The differences included labelling, artwork, QR code verification, cap colour, licence details and packaging text.
Indian Immunologicals Ltd, the manufacturer of Abhayrab, said the seized vials bearing batch KE25012 were not made by the company. It said the genuine batch KE25012 comprised 83,370 vials released under a Batch Release Certificate dated November 7, 2025, and was distributed through authorised channels.
The company maintains that patients who received Abhayrab through hospitals, clinics, government facilities or licensed pharmacies are not affected by the issue involving the seized vials. Indian Immunologicals holds a 40% share of India's domestic rabies vaccine market and has supplied more than 210 million doses of Abhayrab in India and other countries over more than two decades.
The Drugs Controller General of India issued a communication dated August 27 asking state drug regulators to maintain strict vigilance over the movement and distribution of batch KE25012. The federal drug regulator said no part of batch KE25012 had been exported to any other country.
Investigators have not said whether any recipients of the suspected counterfeit vials have been identified. There is also no confirmed evidence that the vials caused inadequate protection or failed post-exposure prophylaxis. The route by which the products reached consumers or clinics, the source of the counterfeit packaging and the full extent of the operation remain unknown.
A Crime Branch raid in Mukherjee Nagar earlier this year recovered 953 rabies vaccine vials among medicines in an alleged spurious-drug racket. There is currently no evidence establishing that those vials were from batch KE25012.
This is the second counterfeit-related concern involving Abhayrab in less than two years. In January 2025, Indian Immunologicals informed the drug regulator that counterfeit Abhayrab doses bearing batch number KA24014 had entered the market.
Health authorities in the United States, Britain and Australia issued alerts for travellers who may have received the vaccine in India in connection with the earlier case. Australia's immunisation advisory group said people who had received the affected counterfeit vaccine could not be assumed to have been adequately protected and advised replacement vaccination in relevant cases.
India records an estimated 5,726 human rabies deaths annually, according to a 2024 study by the Indian Council of Medical Research's National Institute of Epidemiology. The findings on batch KE25012 place renewed focus on the integrity of vaccine supplies where recipients may have little way to distinguish genuine products from suspected counterfeit vials.
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