The clarification came days after the Australian Technical Advisory Group on Immunisation issued an alert claiming counterfeit batches of the vaccine have been circulating in India since November 2023.
IIL has been manufacturing Abhayrab in India since 2000.
In a statement, IIL “strongly refuted the over-cautionary and misplaced reference to 2023”, adding that the alert “does not reflect the current situation”.
“IIL aims 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,” added Sunil Tiwari, Vice President and Head of Quality Management at IIL, in the statement.
The company noted that since the year 2000, more than 210 million doses of Abhayrab have been supplied across India and 40 countries. The anti-rabies vaccine continues to hold a 40 per cent market share in India.
People who have received the counterfeit vaccine may not be fully protected against rabies, said the Australian health authorities, while advising people vaccinated with Abhayrab from November 1, 2023, onwards to see their healthcare provider to check if replacement doses are needed.
“In January 2025, IIL proactively identified a packaging anomaly in one specific batch (Batch # KA 24014). The company immediately notified Indian regulators and law enforcement agencies, lodged a formal complaint, and worked closely with authorities to ensure swift action,” IIL said.
Calling it an “isolated incident”, the drugmaker stated that “the counterfeit batch is no longer available on the shelves”.
The company also reassured healthcare professionals and the public of safe vaccines, as per IANS reported.
“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. Supplies made through government institutions and authorised distributors remain safe and of standard quality,” IIL said.
Rabies is a viral zoonotic disease that affects the central nervous system. Infected dogs are responsible for transmitting the virus in the vast majority of rabies cases among humans.
The disease is fatal in 100 per cent of cases, once it infects the central nervous system and clinical symptoms appear.
According to the World Health Organization (WHO), India records an estimated 18,000–20,000 rabies deaths each year, most of them following dog bites.
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