Australia issues advisory on counterfeit anti-rabies vaccine in India; pharma refutes charges

Indian Immunologicals Limited (IIL), one of India’s leading vaccine manufacturers, has issued a clarification on Saturday (December 27, 2025) regarding recent reports surrounding its human anti-rabies vaccine, Abhayrab.

In it’s statement it said that the company strongly refuted the over-cautionary and misplaced Australian health advisory adding that the counterfeiting incident that has been mentioned involving it’s rabies vaccine 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.

Earlier this week the Australian Technical Advisory Group on Immunisation issued an alert about counterfeit batches of the vaccine Abhayrab circulating in India since November 1, 2023.

It said that Australian travellers who have been administered with Anti-Rabies vaccine – 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. It’s nearly always fatal once symptoms develop, but it is preventable with immediate medical care after exposure.

In it’s statement the company further said that the vaccine has been manufactured by IIL since 2000, with more than 210 million doses supplied across India and 40 countries, and continues 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 is an isolated incident, and the counterfeit batch is no longer available on the shelves.

Reassuring healthcare professionals and the public, IIL emphasized 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 authorized distributors remain safe and of standard quality,” said Sunil Tiwari, Vice President & 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 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 also issued health warnings for India and Haiti after travelers from those countries were diagnosed with rabies.

In its advisory travellers were advised to avoid contact with dogs, cats, and wild mammals in both countries.