Indian Immunologicals rejects Australian warning on fake rabies vaccine

Indian Immunologicals Limited (IIL) has dismissed an alert issued by Australian health authorities warning of counterfeit doses of its anti-rabies vaccine circulating in India, asserting that the caution is outdated and misleading.

The Hyderabad-based vaccine maker said on Saturday that references to fake batches of its rabies vaccine, Abhayrab, dating back to 2023 do not reflect the present ground reality. The clarification comes after the Australian Technical Advisory Group on Immunisation issued an advisory claiming counterfeit Abhayrab doses had been in circulation in India since November 2023.

In a statement, IIL said it “strongly refutes” the alert, describing it as over-cautious and misplaced. The company added that its pharmacovigilance, manufacturing and quality assurance systems remain robust, and that vaccines supplied through its authorised channels are safe.

Sunil Tiwari, Vice President and Head of Quality Management at IIL, said the public and healthcare providers could continue to place confidence in vaccines supplied directly by the company and its approved distributors.

IIL said it has been manufacturing Abhayrab since 2000 and has supplied more than 210 million doses across India and over 40 countries. The vaccine currently accounts for around 40 per cent of India’s anti-rabies vaccine market.

The company acknowledged that in January 2025 it detected a packaging anomaly in a single batch, identified as KA 24014. It said the issue was promptly reported to Indian drug regulators and law enforcement agencies, a formal complaint was filed, and corrective action was taken in coordination with authorities.

Describing the matter as an isolated incident, IIL said the counterfeit batch was no longer available in the market. It also stressed that every vaccine batch manufactured in India is tested and released by the Central Drugs Laboratory before being cleared for sale or use.

Australian health authorities had warned that individuals who may have received counterfeit doses could be inadequately protected against rabies, advising those vaccinated with Abhayrab from November 1, 2023 onwards to consult healthcare providers to assess the need for replacement doses.

Rabies is a viral zoonotic disease that attacks the central nervous system and is almost always transmitted to humans through dog bites. Once clinical symptoms appear, the disease is invariably fatal. According to the World Health Organization, India accounts for an estimated 18,000 to 20,000 rabies deaths annually, making it one of the most affected countries globally.

With IANS inputs