The Australian Technical Advisory Group on Immunization (ATAGI) recommended on 19 December that Australian travelers who received the ‘Abhayrab’ rabies vaccine in India after 1 November 2023 should consider the vaccination invalid and start a new immunisation. However, its manufacturer, Indian Immunologicals Limited (IIL), has clarified that the problem is with a specific batch identified in January 2025 and does not warrant a blanket warning, according to PTI.
Abhayrab has been manufacturing IIL since 2000 with over 210 million doses distributed across India and 40 other countries and reportedly continues to maintain a 40 percent market share in India.
What does the counseling center say?
“Pharmaceutical manufacturer Indian Immunologicals Limited has reported that counterfeit (fake) batches of Abhayrab® rabies vaccine are in circulation in India from 2023. The fake vaccine differs from the registered vaccine in formulation, packaging, labeling and manufacturing,” the advisory said.
He said that individuals who received the counterfeit vaccine may not be fully protected against rabies and should receive booster doses to ensure adequate immunity, noting that although rabies infection is fatal, the disease remains very rare after potential exposure among travelers.
“ATAGI will continue to investigate evidence of fake rabies vaccines circulating overseas and will update this guidance as necessary,” he added.
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Producer ‘Abhayrab’ IIL reacts
She said the recommendation in its current form could cause anxiety and mistrust among the public and health professionals, and urged the Australian Government to consider reviewing it. The IIL wrote to ATAGI and strongly rejected the “overly cautious and misplaced reference” to a batch of vaccine produced in March 2024, the report said.
The manufacturer said it proactively detected a packaging anomaly in one particular batch in January 2025, notified Indian regulators and law enforcement, filed a formal complaint and worked closely with authorities to ensure swift action.
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The letter, sent on December 25, read: “The counterfeiting incident referred to relates to Abhayrab, Batch No. KA24014 (Date of Manufacture: March 2024; Expiration Date: February 2027), which we identified in early January 2025. This is the first such incident in the history of the IIL vaccine.”
The IIL mentioned that the Delhi Drugs Control Department had issued a notification on March 23, 2025 specifically regarding Batch No. KA24014. They noted that this advice, which was publicly available, was referenced by ATAGI in its guidance for Australian travelers to India.
The company said that Batch No. KA24014 of Abhayrabu has been distributed through authorized channels across India and that no complaints have been reported, underscoring the quality and efficacy of the vaccine. They also clarified that there are no other counterfeit batches apart from this one, describing the situation as an isolated incident and stating that the affected batch is no longer available in the market.
The IIL urged ATAGI to reconsider the recommendation to avoid possible misinterpretations by healthcare professionals and to avoid any undue public concern, especially given the limited general awareness of the technical details of the vaccine.
The IIL assured health professionals and the public of the product’s efficacy, stressing that “every batch of vaccine manufactured in India is tested and cleared by the Central Drugs Laboratory (Government of India) before it is made available for sale or administration”.
The company has confirmed that supplies distributed through government institutions and authorized distributors remain safe and meet standard quality.
Meanwhile, Sunil Tiwari, vice president and head of quality management at IIL, said they aim to reassure stakeholders that the company’s pharmacovigilance and quality systems are robust and that the public can continue to trust vaccines supplied directly by IIL and its authorized channels.
Key things
- Indian Immunologicals Limited (IIL), has clarified that the problem relates to a specific batch identified in January 2025 and does not warrant a general warning,
- Abhayrab has been manufacturing IIL since 2000 with over 210 million doses distributed across India and 40 other countries.
- ATAGI advised on 19 December that Australian travelers who received the ‘Abhayrab’ rabies vaccine in India after 1 November 2023 should consider the vaccination invalid.
