The advisory also claimed that fake vaccine batches have been circulating in India since November 2023, a timeline IIL has disputed.
Published Dec 28, 2025 | 11:16 AM ⚊ Updated Dec 28, 2025 | 11:16 AM
Representational image. Credit: iStock
Synopsis: Indian Immunologicals Limited (IIL) rejected an Australian advisory warning of counterfeit Abhayrab rabies vaccines, calling it outdated and over-cautious. IIL insists only one batch was affected in January 2025 and is no longer in circulation. While IIL stresses its quality systems remain robust, Australian authorities maintain travellers should replace doses, leaving patients caught between conflicting guidance.
Hyderabad-based vaccine manufacturer Indian Immunologicals Limited (IIL) strongly rejected an advisory issued by Australian health authorities warning of counterfeit batches of its rabies vaccine Abhayrab, calling the alert outdated and not reflective of current ground realities.
The pushback comes days after the Australian Technical Advisory Group on Immunisation (ATAGI) warned on 19 December that travellers who received Abhayrab in India from 1 November 2023 onwards “may not be fully protected against rabies” and should seek replacement doses.
However, IIL clarified on Saturday that the concern revolves around a single, specific batch identified in January 2025, and insisted the advisory does not merit a blanket warning against the vaccine.
“In January 2025, IIL proactively identified a packaging anomaly in one specific batch (batch number KA 24014), with a packaging different to the original,” the company said in a statement responding to the Australian alert.
IIL emphasised it had “immediately notified Indian regulators and law enforcement agencies, lodged a formal complaint and worked closely with authorities to ensure swift action”.
Describing the matter as an isolated incident, the manufacturer insisted the counterfeit batch is no longer available on shelves and that the situation has been resolved.
“IIL strongly refutes the alert, describing it as over-cautious and misplaced,” the statement read, adding that its “pharmacovigilance, manufacturing and quality assurance systems remain robust”.
Manufactured by IIL since 2000, more than 210 million doses of Abhayrab have been supplied across India and 43 countries, with the vaccine holding approximately 40 per cent market share in India’s anti-rabies vaccine sector.
Sunil Tiwari, vice-president and head of quality management at IIL, sought 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”.
The company stressed that “supplies made through government institutions and authorised distributors remain safe and of standard quality”.
IIL also 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”.
The Australian health alert, which targeted people who have visited India since November 2023, stated that “because it is difficult to confirm whether a genuine or fake product was used, any dose of Abhayrab or any dose where the brand is unknown that meets the criteria above should be considered invalid and replaced with a rabies vaccine registered in Australia”.
ATAGI advised that affected individuals should “consult a healthcare provider, who can help them identify invalid doses and complete a valid course” using vaccines registered in Australia.
The advisory also claimed that fake vaccine batches have been circulating in India since November 2023, a timeline IIL has disputed.
According to the Drugs Control Department of the Government of NCT of Delhi, in a letter dated 28 March 2025, officials warned that “the counterfeit product exhibits several differences compared to original product and may pose a significant risk to public health and safety and is circulated in market without maintaining required cold chain (2-8°C)”.
The counterfeit product was reportedly found in markets across Delhi, Mumbai, Ahmedabad and Lucknow.
Despite IIL’s reassurances, Australian health authorities maintain their position. ATAGI warned that “while infection with rabies is fatal, it is important to note that rabies disease after a potential exposure remains very rare among travellers”.
For those travelling to India, ATAGI advised people to “avoid contact with animals when travelling to countries where rabies occurs” and stressed that “anyone who is scratched, bitten or exposed to the saliva of an animal should seek immediate medical care”.
The advisory also urged travellers to “be aware of the potential for fake vaccines and keep detailed records of any vaccines received outside of Australia, including dates, product names, and batch numbers” and to “where possible, take a photo of the vaccine packaging and label”.
Valid vaccine doses available in India, according to Australian authorities, include Vaxirab-N, RABIVAX-S, Lyssavac, Vaxirab and Indirab.
ATAGI stated it “will continue to review the evidence for fake rabies vaccines circulating overseas, and will update this guidance if required”.
The dispute highlights the tension between international health advisories and manufacturer assurances, leaving patients and healthcare providers to navigate conflicting information about vaccine safety.
(Edited by Amit Vasudev)
