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India’s drug regulator has alerted states to remain vigilant over a suspected counterfeit batch of Abhayrab rabies vaccine after laboratory testing found that the product failed a required potency test and showed multiple discrepancies in its packaging and labelling.
The batch under investigation is identified as KE25012. Samples were seized from an unlicensed residential premises in Delhi and were subsequently examined by the Central Drugs Laboratory in Kasauli. Authorities have raised concerns over the authenticity of the vaccine and are investigating whether the product is a spurious drug.
The development is particularly significant because rabies is almost invariably fatal once clinical symptoms appear, making effective post-exposure vaccination a critical part of preventing the disease.
Which Abhayrab Batch Is Under Investigation?
The batch at the centre of the latest investigation is Abhayrab batch KE25012.
According to the Central Drugs Standard Control Organisation (CDSCO), samples carrying this batch number were seized from an unlicensed premises in Mukherjee Nagar, Delhi. A government laboratory subsequently classified the tested sample as “Not of Standard Quality” after it failed the potency requirement.
The Drugs Controller General of India (DCGI), Rajeev Singh Raghuvanshi, issued a communication to state drug controllers on August 27 asking them to maintain strict vigilance over the movement, distribution and availability of the batch.
Authorities have also taken legal action in the case, with four people reportedly arrested in connection with the investigation.
Why Is the Abhayrab Batch Considered Suspicious?
The investigation is not based solely on the vaccine failing its potency test.
Laboratory and regulatory checks found several differences between the seized vials and genuine reference samples associated with Abhayrab. The discrepancies reportedly included labelling, packaging, QR-code verification, artwork, licence details, cap colour and other printed information.
The Indian Express reported examples of unusual packaging errors, including differences in fonts and spacing, an altered company logo and spelling discrepancies such as “L Posteur” instead of “L Pasteur.” Such differences raised questions about whether the vials were genuinely manufactured by the authorised producer.
Indian Immunologicals Limited (IIL), the manufacturer of Abhayrab, has said that the seized vials were not manufactured by the company.
What Did the Potency Test Show?
The Central Drugs Laboratory in Kasauli found that the field sample did not meet the required potency standard.
Interestingly, the sample reportedly passed several other laboratory checks, including tests related to sterility, moisture and identity. However, the potency failure, combined with discrepancies in the product’s packaging and labelling, prompted regulators to investigate whether the product could be counterfeit or spurious.
Potency is especially important for a rabies vaccine because the purpose of vaccination after a potential exposure is to generate an adequate immune response before the virus reaches the nervous system.
Was the Genuine Abhayrab Vaccine Made by Indian Immunologicals?
Yes. Indian Immunologicals Limited is the manufacturer of Abhayrab, and the company has strongly distinguished the suspected batch from its authorised products.
IIL said the vials examined by regulators were not manufactured by it. The company has provided its batch records to authorities and is cooperating with the investigation into the source of the suspected counterfeit vaccine.
The company has also said that its genuine vaccines distributed through authorised channels remain unaffected by the latest incident.
IIL has supplied more than 210 million doses of Abhayrab in India and other countries over more than two decades and has said the vaccine accounts for around 40% of India’s rabies vaccine market.
Was Batch KE25012 Exported Outside India?
According to India’s drug regulator, no part of the suspected KE25012 batch was exported to another country.
The regulator has therefore focused its current alert on monitoring the batch within India. However, authorities are continuing to investigate how the suspected counterfeit product entered circulation and how widely it may have been distributed.
This is an important distinction from the earlier counterfeit Abhayrab case, which triggered international health alerts because travellers could potentially have received the affected vaccine in India.
This Is Not the First Counterfeit Abhayrab Case
The latest investigation follows an earlier counterfeit Abhayrab incident involving batch KA24014.
Indian Immunologicals informed Indian authorities in January 2025 that counterfeit doses carrying that batch number had entered the market. International health authorities subsequently issued warnings for travellers who may have received the vaccine in India.
Australian health authorities advised people who had received Abhayrab in India under the affected circumstances to consult healthcare professionals because counterfeit doses might not provide adequate protection against rabies.
The earlier incident involved a different batch from the KE25012 batch now under investigation.
Why Is a Counterfeit Rabies Vaccine a Serious Public Health Concern?
Counterfeit vaccines can pose a major public health risk because patients may believe they have received effective protection when they have not.
This is particularly concerning with rabies. Once symptoms develop, rabies is almost invariably fatal, which makes timely and effective post-exposure prophylaxis essential following a potentially infectious animal bite or exposure.
India has a substantial rabies burden, with estimates indicating nearly 6,000 human rabies deaths annually. That makes the integrity of rabies vaccine supplies especially important.
A suspected counterfeit product could therefore create a hidden risk: a person may complete what appears to be a vaccination course without realising that one or more doses may not provide adequate protection.
What Has the Indian Drug Regulator Asked States to Do?
The CDSCO has instructed state drug regulators to maintain strict vigilance over the movement, distribution and availability of Abhayrab batch KE25012.
State authorities have been asked to take appropriate regulatory action wherever necessary and to monitor the market for the suspected batch.
The investigation is expected to focus on the origin of the vials, their distribution network and the individuals or entities responsible for introducing the suspected counterfeit product into circulation.
Are All Abhayrab Vaccines Unsafe?
No. The current investigation concerns a specific suspected counterfeit batch, KE25012, and should not be interpreted as a finding that all Abhayrab vaccines are counterfeit or ineffective.
Indian Immunologicals has stated that vaccines supplied through authorised channels are unaffected. The company has also said that genuine Abhayrab batches undergo independent government testing before release.
Consumers should therefore avoid assuming that every Abhayrab dose is affected solely because of the latest investigation.
Anyone who has concerns about a vaccine dose should consult a qualified healthcare professional or the relevant drug-control authority rather than attempting to determine vaccine authenticity independently.
What Should People Do If They Are Concerned About a Rabies Vaccine Dose?
People who believe they may have received a suspected counterfeit rabies vaccine should contact a healthcare professional promptly, particularly if the vaccine was administered after a possible rabies exposure.
Healthcare professionals can review the vaccination record, vaccine brand, batch information and timing of the exposure and determine whether additional action is required.
Because rabies prevention is time-sensitive, people should not delay seeking professional advice while waiting for the regulatory investigation to conclude.
What Happens Next in the Abhayrab Investigation?
Authorities are now working to establish how the suspected counterfeit KE25012 vials were manufactured, obtained and distributed.
The investigation will also need to determine the scale of circulation and whether additional locations or individuals are connected to the suspected counterfeit supply chain.
At present, the authorities’ findings concern the specific samples seized and tested. Further investigation will determine whether the problem was isolated or involved a wider distribution network.
The investigation into Abhayrab batch KE25012 has raised fresh concerns about counterfeit rabies vaccines in India. The suspected batch failed a potency test and showed multiple discrepancies in labelling, packaging and other product characteristics, prompting regulators to classify the sample as not of standard quality and investigate its possible status as a spurious drug.
Indian Immunologicals has denied manufacturing the seized vials and says genuine Abhayrab supplies through authorised channels remain unaffected.
The case also highlights the importance of pharmaceutical supply-chain controls, especially for vaccines used to prevent diseases such as rabies. As the investigation continues, authorities are expected to focus on tracing the source and distribution of the suspected counterfeit batch while ensuring that patients have access to reliable and effective rabies vaccination.
