Australia flags counterfeit anti-rabies vaccine in India, manufacturer refutes allegations

New Delhi: A government owned Indian vaccine manufacturer has asked an Australian health agency to review a health advisory on anti-rabies vaccine Abhayrab after authorities in Down Under alerted their citizens about multiple batches of counterfeit vaccine that have been in circulation since November 2023.

But the vaccine maker, Indian Immunologicals Limited, said the counterfeit product belonged to only one particular batch that has been taken off the shelf and such a general advisory would trigger “unnecessary anxiety among medical professionals and general public.”

In an alert the Australian Technical Advisory Group on Immunisation said, “Counterfeit batches of rabies vaccine Abhayrab have been circulating in India since November 2023. People who have received the counterfeit vaccine may not be fully protected against rabies.”

“People who have received Abhayrab, or an unknown rabies vaccine brand, in India from November 1, 2023 onwards are advised to see their healthcare provider to check if replacement doses are needed,” it added.

“Clinicians should offer replacement doses with a rabies vaccine registered in Australia to people who have received Abhayrab or an unknown rabies vaccine brand in India,” the ATAGI said.

The IIL has written to the Australian agency, strongly refuting the "over-cautionary and misplaced reference" to a batch of vaccine manufactured in March 2024, and said it had proactively identified a packaging anomaly in one specific batch in January 2025, notified Indian regulators and law enforcement agencies, lodged a formal complaint, and worked closely with authorities to ensure swift action.

In its Dec 25 reply, the ILL, a wholly owned subsidiary of National Dairy Development Board, said the counterfeit incident belonged to only one particular batch (No: KA24014) and the company detected it in January 2025.

“This was an isolated incident, and the counterfeit batch is no longer available on the shelves,” the company said in a statement on Saturday.

The company requested the ATAGI to “consider reviewing the advisory notification” to mitigate “any negative impact on public trust in vaccines.”

“A clarification by ATAGI stating that the reported counterfeit incident is confined to a specific batch would greatly contribute to ensuring safety while avoiding unnecessary anxiety among medical professionals and the general public,” it said.

After the company alerted the CDSCO in January, the Drugs Control Department of Delhi government issued a notice saying the counterfeit vaccine was available in the markets of Delhi, Mumbai, Ahmedabad and Lucknow.

The manufacturer said it supplied more than 210 million doses of Abhayrab vaccine to the Indian international markets. The vaccine has a market share of 40% of the national anti-rabies vaccine market.