Fake rabies vaccine row: IIL says counterfeit batch no longer available

Indian Immunologicals Limited said the issue flagged by Australian authorities relates to a single counterfeit batch identified earlier and does not warrant a blanket warning against the vaccine

Days after Australia issued an advisory against counterfeit batches of rabies vaccine Abhayrab, public sector manufacturer Indian Immunologicals Limited (IIL) clarified that the concern revolves around a specific batch identified in January 2025, and did not merit a blanket warning against it.

 

This comes after a health alert released by the Australian Technical Advisory Group on Immunisation (ATAGI) and state health departments warned that travellers who have received this vaccine (Abhayrab) in India since November 1, 2023, may be completely unprotected against the virus.

 

The alert also claimed that counterfeit batches of Abhayrab have been circulating in India since November 2023.

 

 

“In January 2025, IIL proactively identified a packaging anomaly in one specific batch (batch number KA 24014), with a packaging different to the original,” IIL said in a statement responding to the Australian alert. 

 

The company added that it had immediately notified Indian regulators and law enforcement agencies, lodged a formal complaint and worked closely with authorities to ensure swift action.

 

Calling it an isolated incident, IIL added that the counterfeit batch is no longer available on the shelves.

 

Manufactured by IIL since 2000, more than 210 million doses of Abhayrab have been supplied across India and 43 countries, with the vaccine holding a 40 per cent market share in India.

 

While Abhayrab is not available in Australia, the alerts were targeted at people who have visited India since November 2023. 

 

According to the World Health Organisation (WHO), India has the largest number of animal bites in the world and accounts for a significant portion of the global rabies burden.  

 

A parliamentary response by the Ministry of Fisheries, Animal Husbandry and Dairying put the figure of dog bite incidents at 3.7 million in 2024, a 76 per cent rise from 2.1 million incidents recorded in 2022.

 

The number of rabies deaths has also risen from 21 in 2022 to 54 in 2024. 

 

Reassuring healthcare professionals and the public, IIL emphasised that 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,” it further said. 

 

Sunil Tiwari, vice-president and head of quality management at IIL, added that the firm 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.