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India Flags Abhayrab Rabies Vaccine Batch Over Potency Concerns
India’s drug regulator found a batch of Abhayrab rabies vaccine that did not work strongly enough in a potency test.
The batch is called KE25012.
The sample passed some safety checks, including tests for sterility and identity.
However, its packaging and other details did not match the company’s reference sample.
Officials are investigating whether the vaccine could be fake or incorrectly labeled.
Abhayrab is used to help protect people before or after exposure to rabies.
Rabies causes thousands of deaths in India each year and is usually fatal after symptoms appear.
The authorities have told officials to watch how this batch is distributed.
India’s drug regulator flagged Abhayrab batch KE25012 after a government laboratory found it failed a potency test.
The sample passed sterility, moisture and identity tests but differed from a retained reference sample in packaging and verification details.
Officials cited discrepancies involving labels, artwork, QR codes, cap color, license details and packaging text.
The regulator ordered strict vigilance and said the findings warranted investigation into whether the batch was spurious.
A separate counterfeit Abhayrab batch, KA24014, was reported in January 2025, prompting travel alerts from the United States, Britain and Australia.
- Who
- India’s drug regulator, the Central Drugs Laboratory in Kasauli and Indian Immunologicals Ltd are involved.
- What
- A batch of Abhayrab rabies vaccine was classified as not of standard quality and potentially spurious after failing a potency test.
- Where
- India; the laboratory testing took place at the Central Drugs Laboratory in Kasauli.
- When
- The regulator issued its letter on August 27; the report was published on September 5, 2026. A separate counterfeit batch was reported in January 2025.
- Why
- The batch failed potency requirements and showed differences from a retained reference sample, raising concerns about its identity and authenticity.
Regulatory concerns
Manufacturer’s earlier position
Authenticity of the flagged product
Regulatory concerns
India’s regulator said differences in potency, labeling, artwork, QR-code verification, cap color, license details and packaging text raised concerns about the sample’s identity and authenticity.
Manufacturer’s earlier position
Indian Immunologicals did not respond to requests for comment about the latest finding. In the earlier KA24014 case, the company said it had not manufactured the counterfeit batch and described that incident as isolated.
Scope of the problem
Regulatory concerns
The regulator ordered strict vigilance over the movement and distribution of batch KE25012 and said further regulatory action could be necessary.
Manufacturer’s earlier position
The government document does not say how many doses of KE25012 were distributed, whether any were exported or whether foreign regulators were notified.
Key facts
- Flagged batch
- Abhayrab batch KE25012
- Laboratory finding
- The sample failed a potency test and was classified as not of standard quality and misbranded.
- Earlier counterfeit batch
- Batch KA24014 was reported by Indian Immunologicals in January 2025.
- Indian market share
- Indian Immunologicals said Abhayrab held a 40% share of India’s domestic rabies vaccine market in December.
- Supply record
- Indian Immunologicals has supplied more than 210 million Abhayrab doses in India and other countries over more than two decades.
- Rabies deaths
- A 2024 study estimated 5,726 human rabies deaths annually in India.
- Export reach
- Indian Immunologicals exports Abhayrab to more than 40 countries.
Sources
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