Australian Travelers Urged to Revaccinate Against Rabies Following Counterfeit Vaccine Alert in India
Australian travelers who received a rabies vaccination with the Abhayrab vaccine in India after November 1, 2023, are being advised to consider their vaccination invalid and begin a new course, following reports of counterfeit batches circulating within the country.
The alert, issued by the Australian Technical Advisory Group on Immunisation, stems from a counterfeiting incident involving Abhayrab – a human anti-rabies vaccine manufactured by Indian Immunologicals Limited (IIL). IIL, one of India’s leading vaccine manufacturers, swiftly refuted the Australian advisory as “over-cautionary and misplaced” in a statement released Saturday, December 27, 2025.
According to a company release, the counterfeit batch – identified as Batch No. KA24014 (manufacturing date: March 2024; expiry date: February 2027) – was detected as early as January 2025. IIL confirmed that the compromised batch has since been removed from circulation.
“The counterfeiting incident involving our rabies vaccine Abhayrab was identified by early January 2025, and the counterfeit batch is no longer available on the shelves,” a senior official stated.
The initial alert from the Australian advisory group highlighted the risk to travelers who may have received a non-effective vaccine, leaving them vulnerable to the potentially fatal rabies virus. Rabies is a viral zoonotic disease that attacks the central nervous system and is almost invariably fatal once symptoms manifest, though it is preventable with prompt medical intervention following exposure.
IIL emphasized the scale of its vaccine production, stating that it has manufactured the vaccine since 2000, distributing over 210 million doses across India and 40 other countries, currently holding a 40% market share in India. The company detailed its swift response to the anomaly.
“In January 2025, IIL 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,” the release continued, reiterating that the incident is isolated.
To reassure healthcare professionals and the public, IIL underscored its rigorous quality control processes. Every batch of vaccine produced in India undergoes testing and approval by the Central Drugs Laboratory (Government of India) before distribution. “Supplies made through government institutions and authorized distributors remain safe and of standard quality,” affirmed Sunil Tiwari, Vice President & Head of Quality Management at IIL.
IIL has directly communicated with the Australian Technical Advisory Group on Immunisation, asserting that Abhayrab is a purified cell culture-based rabies vaccine manufactured in strict adherence to regulatory standards, including WHO Good Manufacturing Practices (GMP) and relevant pharmacopeial standards. The vaccine is utilized for both pre- and post-exposure rabies prophylaxis and is distributed through both public and private healthcare channels.
“Every batch of vaccine manufactured in India is tested and released by National Control Laboratory (Central Drugs Laboratory), which is a WHO-Geneva pre-qualified laboratory under National Regulatory Authority,” the company added.
The incident comes as health authorities globally remain vigilant regarding rabies transmission. Earlier this month, the Centers for Disease Control and Prevention issued health warnings for both India and Haiti after travelers returning from those countries were diagnosed with the disease. The CDC advisory urged travelers to avoid contact with dogs, cats, and wild mammals in both nations.
The situation underscores the critical importance of vaccine supply chain integrity and the need for continued vigilance in safeguarding public health.