The Australian Department of Health has issued a significant alert concerning a leading Indian-manufactured anti-rabies vaccine, alleging that counterfeit versions have been in circulation in India since November 2023. The advisory specifically names the vaccine Abhayrab, produced by Indian Immunologicals Limited (IIL), urging recipients to consult healthcare providers about potential replacement doses.
Indian Manufacturer's Strong Rebuttal
Indian Immunologicals Limited has issued a firm clarification, strongly refuting the Australian advisory's implication that fake vaccines have been widely circulating since last year. In an official statement, the company described the reference to 2023 as "over-cautionary and misplaced" and stressed it does not reflect the current market situation. IIL confirmed it has already written to Australian health authorities requesting a revision of the alert.
The Hyderabad-based vaccine maker explained that in January 2024, it proactively identified a specific batch of its Abhayrab vaccine (Batch #KA24014) in the market with different, non-standard packaging. The company immediately notified Indian regulators and law enforcement agencies, leading to swift action. IIL emphasized that there have been no complaints regarding genuine products bearing the same batch number and asserted, "There is no instance of any other counterfeit batch in the market beyond Batch no. #KA24014."
Details of the Australian Health Advisory
The Australian alert, issued earlier this week, explicitly states that while the Abhayrab vaccine is not available in Australia, individuals who received it while in India "may be impacted." It advises healthcare professionals to replace any doses of Abhayrab or an unknown rabies vaccine administered in India with other vaccines registered in Australia.
Striking a cautionary tone, the advisory notes the difficulty in confirming a vaccine's authenticity. It recommends, "As a precaution, people who have received any dose of Abhayrab in India from November 1, 2023 onwards should be considered to have potentially received the counterfeit vaccine and offered replacement doses."
Precautions for Travellers and Broader Acceptance
The Australian health department also provided guidance for travellers to rabies-endemic countries, which includes:
- Avoiding contact with wild and domestic animals.
- Seeking immediate medical care if bitten, scratched, or exposed to animal saliva.
- Keeping detailed records of any vaccines received overseas.
- Consulting a General Practitioner upon returning to Australia.
Importantly, the advisory does not constitute a blanket rejection of Indian vaccines. The Australian "immunisation handbook" continues to accept several other rabies vaccines manufactured in India, including those from Cadila, Serum Institute of India, and Bharat Biotech. The Abhayrab vaccine itself remains accepted in Australia, provided it was not administered within India.
This incident highlights the critical importance of pharmaceutical supply chain vigilance and international coordination in public health alerts. While Indian authorities acted on the specific counterfeit batch earlier this year, the international advisory underscores ongoing concerns about drug safety and the need for travellers to remain informed about their medical history.
