The Australian government has issued a significant health advisory for its citizens who travelled to India, concerning a potentially counterfeit rabies vaccine. The warning has sparked a strong rebuttal from the Indian manufacturer, highlighting a clash over the scale and interpretation of the issue.
What Does the Australian Advisory Say?
On December 19, the Australian Technical Advisory Group on Immunisation (ATAGI) issued guidance stating that Australian travellers who received the Abhayrab rabies vaccine in India after November 1, 2023, should consider that vaccination invalid. They are advised to begin a fresh course of immunisation immediately.
The advisory explicitly warned that fake batches of Abhayrab have been circulating in India since 2023. It noted that the counterfeit vaccine differs from the genuine product in its formulation, packaging, labelling, and manufacturing process. ATAGI cautioned that individuals who received the fake vaccine may not be protected against rabies, a disease that is almost always fatal once symptoms appear. The group stated it would continue to review evidence and update its guidance as needed.
Manufacturer IIL's Firm Rejection
The manufacturer, Hyderabad-based Indian Immunologicals Limited (IIL), has firmly pushed back against the broad Australian warning. In a letter dated December 25 to ATAGI, the company labelled the advisory as "over-cautionary and misplaced." IIL clarified that the issue pertains to one specific batch—Batch No. KA24014, manufactured in March 2024—and does not justify a general alert for all vaccines administered after late 2023.
IIL stated that it proactively detected a packaging anomaly in this single batch in early January 2025. Upon discovery, the company immediately informed Indian regulators and law enforcement, filed a formal complaint, and collaborated with authorities. They emphasised that this was the first such incident in the company's history since it began producing Abhayrab in 2000, with over 210 million doses distributed across India and 40 other countries.
An Isolated Incident or a Wider Concern?
The core of the disagreement lies in the scope of the problem. While the Australian advisory suggests circulation of fake vaccines "since 2023," IIL insists the incident is isolated to one batch, which is no longer available on the market. The company pointed to a public notification issued by the Delhi Drugs Control Department on March 23, 2025, which specifically addressed Batch No. KA24014.
IIL sought to reassure the public and healthcare professionals, stressing that every batch of vaccine sold in India is tested and released by the Central Drugs Laboratory before distribution. Sunil Tiwari, Vice President and Head of Quality Management at IIL, stated the company's aim is to reaffirm confidence in its robust pharmacovigilance systems and the safety of vaccines supplied through its authorised channels.
The company has urged ATAGI to reconsider and revise its advisory, warning that the current broad wording could cause unnecessary anxiety and mistrust. For now, Australian travellers who received the Abhayrab vaccine in India are caught between the caution of a foreign government and the assurances of a leading Indian pharmaceutical producer.
