Indian Immunologicals urges review of Australia’s counterfeit rabies vaccine guidance, saying issue was limited to one batch
Indian Immunologicals Limited (IIL), maker of the rabies
vaccine Abhayrab, has formally called on Australian health authorities to reassess a recent public advisory warning travellers about counterfeit rabies
vaccines linked to India.
The company says the advisory, issued after Australian medical bodies reported fake batches circulating, is overly broad and could provoke undue concern among clinicians and the public.
IIL maintains that the questionable product stemmed from a packaging anomaly confined to a single batch that has since been removed from the Indian market.
Australia’s health alert, based on guidance from the Australian Technical Advisory Group on Immunisation (ATAGI), cautioned travellers who received Abhayrab or an unidentified rabies
vaccine in India since November two thousand twenty-three that they may not have adequate protection and should seek follow-up doses with
vaccines registered in Australia.
ATAGI’s statement, issued in mid-December two thousand twenty-five, underscored that counterfeit versions differed in formulation, labelling and packaging and that rabies protection could be incomplete.
IIL, a major public sector
vaccine producer in India, contends that only the single affected batch exhibited irregularities and that its proactive identification and withdrawal mitigated wider circulation.
The firm is pressing Australian authorities to clarify the scope of their advisory so that it reflects the limited nature of the problem and avoids unnecessary alarm among healthcare providers and returnees who received legitimate vaccinations.
The dispute highlights the complexities of international
vaccine regulation and traveller health advisories, particularly for a fatal disease such as rabies, which requires rigorous post-exposure prophylaxis.
Both sides agree on the imperative of ensuring effective immunisation, but IIL’s appeal seeks a more nuanced public health communication that distinguishes isolated quality issues from broader product safety concerns.