Govt Flags Abhayrab Rabies Vaccine Batch as Substandard, Probes Whether It Is Spurious
India’s drug regulator has flagged a batch of the widely used Abhayrab rabies vaccine as “Not of Standard Quality” after a field sample failed a potency test. The government is now investigating whether the batch is a spurious or counterfeit drug, according to a regulatory document reviewed by Reuters.
The batch under scrutiny is KE25012. Samples were seized from an unlicensed residential premises in Mukherjee Nagar, Delhi, where authorities found the vaccine being stored outside authorised pharmaceutical channels.
The Central Drugs Laboratory in Kasauli found that the sample did not meet the required potency standards. Although it passed tests for sterility, moisture and identity, investigators detected substantial differences when it was compared with a reference sample of the same batch held for regulatory purposes.
Authorities identified discrepancies involving the labelling, artwork, QR-code verification, cap colour, licence details and packaging text. The differences have raised concerns about the authenticity of the vaccine and prompted an investigation under India’s Drugs and Cosmetics Act.
Indian Immunologicals Ltd (IIL), the manufacturer of Abhayrab, has strongly denied manufacturing the seized vials. The company said its examination found 17 differences between the seized samples and its retained reference samples for the batch.
IIL has told authorities that the original KE25012 batch contained 83,370 vials distributed through authorised channels. The company said it has provided its batch records to investigators and is cooperating with efforts to trace the source of the suspect products.
The Central Drugs Standard Control Organisation (CDSCO) has asked state drug regulators to maintain strict vigilance over the movement and distribution of Abhayrab bearing batch number KE25012 and to take regulatory action wherever necessary. Four people have been arrested by Delhi Police in connection with the investigation.
The regulator has also clarified that no part of the suspect KE25012 batch was exported, according to its latest statement. The government document, however, does not specify how many suspect doses may have reached patients or whether any doses from the questioned stock were administered.
The development is particularly significant because it is the second major counterfeit-Abhayrab concern in less than two years. In January 2025, authorities were alerted to fake Abhayrab doses carrying batch number KA24014, following which health authorities in several countries issued warnings to travellers who may have received the vaccine in India.
Abhayrab is used for protection against rabies following exposure to potentially infected animals and is also used in government vaccination programmes. IIL says it has supplied more than 210 million doses in India and overseas over more than two decades and has around 40% of India’s rabies vaccine market.
The latest investigation therefore extends beyond the quality of one vaccine sample: authorities are now seeking to establish where the suspect vials were manufactured, how they entered the supply chain, how widely they were distributed and whether the products were deliberately counterfeited. Further regulatory and criminal action is expected as the investigation progresses.
