Australia warns against counterfeit rabies vaccine in India: What advisory says and how 'Abhayrab' manufacturer reacted

The Australian Technical Advisory Group on Immunisation (ATAGI) on December 19 advised that Australian travellers who received the anti-rabies vaccine “Abhayrab” in India after November 1, 2023, should treat the vaccination as invalid and begin a fresh course of immunisation. However, its manufacturer, Indian Immunologicals Limited (IIL), clarified that the issue pertains to a particular batch identified in January 2025 and does not justify a general warning, according to PTI.

Abhayrab has been produced by IIL since 2000, with over 210 million doses distributed across India and 40 other countries and it reportedly continues to maintain a 40 per cent market share in India.

What does the advisory say?

“The pharmaceutical manufacturer Indian Immunologicals Limited has reported that counterfeit (fake) batches of the rabies vaccine Abhayrab® have been circulating in India since 2023. The fake vaccine differs from the registered vaccine in formulation, packaging, labelling, and manufacturing,” the advisory read.

It said individuals who received the counterfeit vaccine may not be fully protected against rabies and should obtain replacement doses to ensure adequate immunity, while noting that although rabies infection is fatal, the disease remains very rare among travellers following potential exposure.

“ATAGI will continue to review the evidence for fake rabies vaccines circulating overseas, and will update this guidance if required,” it added.

'Abhayrab' manufacturer IIL reacts

It stated the advisory in its current form could cause anxiety and mistrust among the public and healthcare professionals and urged the Australian government to consider revisiting it. The IIL has written to ATAGI, firmly rejecting the "over-cautionary and misplaced reference" to a batch of vaccine produced in March 2024, the report noted.

The manufacturer stated that it had proactively detected a packaging anomaly in one specific batch in January 2025, informed Indian regulators and law enforcement agencies, filed a formal complaint, and collaborated closely with authorities to ensure prompt action.

The letter, sent on December 25, read, “The counterfeiting incident that has been mentioned involves Abhayrab, Batch No. KA24014 (manufacturing date: March 2024; expiry date: February 2027) was identified by us in early January 2025. This represents the first such incident in IIL's vaccine history.”

The IIL mentioned that the Delhi Drugs Control Department had issued a notification on March 23, 2025, pertaining specifically to Batch No. KA24014. They noted that this advisory, which was publicly accessible, had been referenced by ATAGI in guidance for Australian travellers to India.

The company indicated that Batch No. KA24014 of Abhayrab was distributed through authorised channels across India and that no complaints had been reported, underlining the vaccine’s quality and efficacy. They also clarified that there were no other counterfeit batches beyond this one, describing the situation as an isolated incident and stating that the affected batch was no longer available on the market.

IIL urged ATAGI to reconsider the advisory to avoid potential misinterpretations by healthcare practitioners and prevent any undue concern among the public, especially given limited general awareness of technical vaccine details.

Reassuring healthcare professionals and the public about the product’s efficacy, IIL stressed that “every batch of vaccine manufactured in India is tested and released by the Central Drugs Laboratory (Government of India) before being made available for sale or administration”.

The company affirmed that supplies distributed through government institutions and authorised 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 place confidence in vaccines supplied directly by IIL and its authorised channels.