Archive · 6 Sep 2026
India Probes Abhayrab Batch After Potency Test Failure
Indian authorities are investigating some Abhayrab rabies vaccine vials.
A government laboratory found that a tested vial did not have enough potency in one test.
It passed tests for sterility, moisture and identity.
However, its packaging and verification details did not match a genuine sample.
The vials had been seized at an unlicensed home in Delhi.
The manufacturer says the seized vials were not made by its company.
It says genuine vials from the same batch were tested and sold through approved channels.
Investigators are trying to find where the questioned vials came from and whether they reached patients.
India’s Central Drugs Laboratory classified a field sample of Abhayrab batch KE25012 as not of standard quality and misbranded after it failed a potency test.
The sample passed sterility, moisture and identity tests but differed from a genuine reference sample in labeling, artwork, QR verification, cap color, license details and packaging text.
The vials were seized from an unlicensed residential premises in Mukherjee Nagar, Delhi, and authorities are investigating whether they were spurious under the Drugs and Cosmetics Act.
Indian Immunologicals Limited said the seized vials were not manufactured by its Human Biologicals Institute division and identified 17 differences from genuine batch samples.
The case follows a 2025 counterfeit concern involving Abhayrab batch KA24014, which led to travel-related alerts from authorities in the United States, Britain and Australia.
- Who
- India’s drug regulators, the Central Drugs Laboratory, Indian Immunologicals Limited and its Human Biologicals Institute division are involved; Drugs Controller General Rajeev Singh Raghuvanshi directed state regulators to act.
- What
- A field sample labeled Abhayrab batch KE25012 failed a potency test and was classified as not of standard quality and misbranded, prompting an investigation into whether it was spurious.
- When
- The seizure occurred on April 22, 2026; the regulator’s vigilance directive was dated August 27, 2026, and Indian Immunologicals submitted its response on September 4, 2026. The reports were published September 5, 2026.
- Where
- The vials were seized at an unlicensed residential premises in Mukherjee Nagar, Delhi, and tested at the Central Drugs Laboratory in Kasauli, India.
- Why
- The sample failed potency requirements and showed multiple differences from a genuine reference sample, raising questions about its identity and authenticity.
Regulatory concerns
Manufacturer’s response
Identity of the seized vials
Regulatory concerns
Authorities say the sample failed potency requirements and differed substantially from a retained genuine reference sample, warranting an investigation into whether it was a spurious drug.
Manufacturer’s response
Indian Immunologicals Limited says the 17 reported differences show that the seized vials were not products manufactured by its Human Biologicals Institute division.
Status of genuine batch KE25012
Regulatory concerns
The regulator classified the tested field sample as not of standard quality and misbranded and ordered strict vigilance over the batch’s movement and distribution.
Manufacturer’s response
The company says the genuine batch was independently tested and released with a Central Drugs Laboratory batch-release certificate dated November 7, 2025, and that 83,370 vials entered authorized channels.
Potential patient exposure
Regulatory concerns
Authorities are investigating how vials carrying the Abhayrab name and genuine batch number reached an unlicensed premises and whether they circulated more widely.
Manufacturer’s response
Indian Immunologicals says patients receiving Abhayrab through hospitals, clinics, government facilities or licensed pharmacies are not affected by the issue involving the seized vials; the overall scope remains unresolved.
- Flagged batch
- Abhayrab batch KE25012
- Laboratory result
- The field sample failed potency requirements and was classified as not of standard quality and misbranded.
- Packaging differences
- The laboratory identified differences involving labeling, artwork, QR-code verification, cap color, license details and packaging text; the manufacturer cited 17 differences overall.
- Manufacturer’s position
- Indian Immunologicals Limited said the seized vials were not manufactured by its Human Biologicals Institute division.
- Genuine supply
- The company said 83,370 genuine KE25012 vials were released through authorized distribution channels after independent testing and batch-release certification.
- Regulatory action
- State drug regulators were told to maintain strict vigilance over the movement, distribution and availability of batch KE25012.
- Earlier concern
- Counterfeit Abhayrab batch KA24014 was reported in January 2025, followed by alerts from the United States, Britain and Australia.
- Unresolved scope
- The articles do not establish how many questioned doses circulated, whether any were exported, or whether foreign regulators were notified about the latest case.
Sources
India’s drug regulator flags rabies vaccine batch as substandard, raising fake dose fears: Report
Twice in 2 years: Fake rabies jab probe plea after substandard vaccine found in Delhi home
Abhayrab rabies vaccine batch flagged as substandard in India
India flags Abhayrab rabies vaccine batch as substandard, probes if spurious
Abhayrab rabies vaccine batch fails potency test, govt launches spurious drug probe
