A government-owned Indian vaccine manufacturer has questioned a December 22 health advisory issued by Australian authorities that warned of “counterfeit batches” of an anti-rabies vaccine circulating in India since November 2023, and has formally requested that the notice be reviewed.Abhayrab Rabies Vaccine Makers Say It Reported Single Counterfeit CaseIndian Immunologicals Limited said it had already reported a counterfeiting incident involving one batch of its anti-rabies vaccine, Abhayrab, in January, and cautioned that the Australian advisory risked creating “anxiety and mistrust” among both the public and medical professionals.However, India’s central drug regulator has not made public whether it carried out an investigation, how widely the fake vaccine may have spread, or how many people might have received it. As a result, the scale of the incident and its possible consequences remain uncertain.Australian Warning Highlights Risk to TravellersThe Australian advisory stated that although Abhayrab is not sold in Australia, individuals who were vaccinated while travelling in India might not be fully protected against rabies, a viral infection of the central nervous system that is almost always fatal if treatment is delayed or missed.Abhayrab Rabies Vaccine: Details of the Australian Advisory“Counterfeit (fake) batches of rabies vaccine Abhayrab have been circulating in India since November 1, 2023,” the advisory directed at travellers and healthcare workers said. “People who have received Abhayrab, or an unknown rabies vaccine brand in India from November 1, 2023, onwards are advised to consult their healthcare provider to assess whether replacement doses are required.”Abhayrab Rabies Vaccine: Similar Alerts Issued by Other CountriesThe Australian notice followed similar warnings elsewhere. On November 25, the US Centers for Disease Control and Prevention reported a rabies case in a traveller returning from India and referred to the circulation of counterfeit Abhayrab vaccines. A UK travel health authority had also released an alert about the falsified vaccine on October 29.Abhayrab Rabies Vaccine: Indian Firm Warns of Public ConfusionIn a communication dated December 25 to Australian health officials, Indian Immunologicals Limited said the advisory could be misunderstood and weaken confidence in vaccines, and asked that it be reconsidered to prevent confusion among healthcare providers.The manufacturer said it has supplied more than 210 million doses of Abhayrab in India and overseas, describing it as “the most trusted brand” in the country and stating that it accounts for around 40 per cent of India’s anti-rabies vaccine market.Abhayrab Rabies Vaccine: Details of the Counterfeit BatchThe company said the counterfeiting involved a single batch, KA-24014, which was manufactured in March 2024 and is due to expire in February 2027. This was reported to India’s Central Drugs Standard Control Organisation on January 13, 2025.According to Indian Immunologicals Limited, the counterfeit vaccine carried the same batch number but listed a manufacturing date of November 2023 and an expiry date of October 2026. The counterfeit packaging also omitted the ₹ symbol before the printed price of 397.62.The firm said it had urged the CDSCO in January to investigate the counterfeiting, seize the fake vaccines, and work with law enforcement agencies to identify and prosecute those responsible for manufacturing and distributing them.Abhayrab Rabies Vaccine: No Response From CDSCOQuestions sent by this newspaper to the CDSCO on Saturday seeking updates on the status or findings of any investigation did not receive a response. Without official information from the regulator, experts say it is difficult to determine how widely the falsified vaccine may have circulated or how many people could have been affected.Concerns Over Wording of AdvisoryA scientist specialising in rabies research in India said the Australian advisory’s reference to “counterfeit batches” and circulation “since November 2023” could alarm many people who have received anti-rabies vaccines, as per The Telegraph.“Abhayrab is a reliable vaccine and is used extensively across the country,” said Reeta Mani, professor and head of neurovirology at the National Institute of Mental Health and Neurosciences in Bengaluru. “Public advisories need precise language. People should not lose faith in vaccines.”Rabies Burden in IndiaA 2022 report by the National Centre for Disease Control estimated that nearly 2.3 million people in India receive post-exposure rabies vaccines each year after animal bites, most commonly from dogs.Research published earlier this year by the Indian Council of Medical Research estimated that rabies causes about 5,700 deaths annually in India, a reduction from earlier estimates of nearly 20,000 deaths per year.Peer-reviewed studies have shown that thousands of people worldwide have received counterfeit rabies vaccines. This includes more than 1,600 recipients in a single Chinese province in 2010, and over 1,13,000 falsified rabies vaccine doses reported by Chinese regulators in 2018.