Australia advised its travellers who have been administered with Anti-Rabies vaccine – Abhayrab in India after November 1, 2023, to consider the vaccination invalid and initiate a new course of vaccination.
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Indian Immunologicals Limited (IIL), one of India’s leading vaccine manufacturers, on Saturday (December 27, 2025) said a counterfeit batch of its human anti-rabies vaccine, Abhayrab, was no longer available on the shelves. The company’s clarification comes in the wake of an Australian health advisory issued last week, warning about the counterfeit batch being in circulation in India since November 1, 2023.
Dismissing the advisory as over-cautionary and misplaced, IIL, in a statement, said the counterfeiting incident involving Abhayrab batch no. KA24014 (manufacturing date: March 2024; expiry date: February 2027) was identified by early January 2025. The counterfeit batch is no longer available on the shelves, it said.
The Australian Technical Advisory Group on Immunisation, in its advisory, said that Australian travellers who had been administered Abhayrab in India after November 1, 2023, should consider the vaccination invalid and initiate a new course of vaccination.
Rabies is a viral zoonotic disease that affects the central nervous system. Once symptoms develop, it is almost always fatal. However, it can be prevented with immediate medical care after exposure.
In its statement, IIL said it had been manufacturing the vaccine since 2000, with more than 210 million doses supplied across India and 40 countries, and continued to hold a 40% market share in India.
“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,” it said, adding that this was an isolated incident, and the counterfeit batch was no longer available on the shelves.
Reassuring healthcare professionals and the public, IIL emphasised that every batch of the vaccine manufactured in India is tested and released by the Central Drugs Laboratory (government of India) before it is made available for sale or administration.
‘Safe and standard’
“Supplies made through government institutions and authorised distributors remain safe and of standard quality,” said Sunil Tiwari, vice-president and head of quality management at IIL. The company has also written to the Australian Technical Advisory Group on Immunisation stating that Abhayrab, a purified cell culture-based anti-rabies vaccine is manufactured in accordance with applicable regulatory requirements, including WHO Good Manufacturing Practices (GMP) and relevant pharmacopeial standards.
It added that the product is intended for use in both pre-exposure and post-exposure prophylaxis against rabies and has been supplied through government procurement channels as well as the private healthcare sector.
“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,” it added.
Meanwhile, earlier this month, the Centers for Disease Control and Prevention issued health warnings for India and Haiti after travellers from these countries were diagnosed with rabies.
It advised travellers to avoid contact with dogs, cats, and wild mammals in both countries.
Published – December 27, 2025 12:43 pm IST
