Indian Immunologicals refutes Australian advisory on rabies vaccine, calls it ‘over-cautionary and misplaced'

New Delhi: Following the Australian Government's advisory against counterfeit rabies vaccine in India, Indian Immunologicals Ltd (IIL), the manufacturer of the flagged vaccine 'Abhayrab', clarified that the concern pertains to a specific batch identified in January 2025 and does not merit a blanket warning against it.

The public sector manufacturer said the advisory, in its current form, could lead to anxiety and mistrust among the public and healthcare practitioners, and therefore asked the Australian Government to consider reviewing it.

About a week ago, the Australian Technical Advisory Group on Immunisation (ATAGI) said that Australian travellers who have received the anti-rabies vaccine Abhayrab in India after November 1, 2023, should consider the vaccination invalid and initiate a new course of immunisation.

Writing to ATAGI, it strongly refuted the "over-cautionary and misplaced reference" to a batch manufactured in March 2024, stating that, after identifying a packaging anomaly in a specific batch in January 2025, it notified Indian regulators and law enforcement agencies, lodged a formal complaint, and worked proactively to ensure swift action.

"The counterfeiting incident that has been mentioned involves Abhayrab, Batch No. KA24014 (manufacturing date: March 2024; expiry date: February 2027) was identified by us in early January 2025. This represents the first such incident in IIL's vaccine history," said the letter sent on December 25.

It further stated that the Drugs Control Department, Government of NCT of Delhi, issued an advisory/notification on March 23, 2025, specific to Batch No. KA24014.

"This advisory was publicly available and was subsequently referenced by your office when issuing guidance for Australian travellers visiting India," the IIL pointed out in the letter.

"We would like to inform you that Abhayrab, Batch No. KA24014, manufactured by us, was distributed across various regions of India through our authorised distribution channels, and no market complaints were reported in relation to this batch," it said.

"This goes on to affirm the quality and efficacy of our vaccine, when procured from our authorised channels. There is no instance of any other counterfeit batch in the market beyond Batch No. KA24014," the IIL stressed.

The vaccine manufacturer clarified that it was an "isolated incident" and that the "counterfeit batch is no longer available on the shelves."

"We humbly request your good office to urgently consider reviewing the advisory notification, in the interest of preventing potential complications in interpretations by healthcare practitioners and mitigating any negative impact on public trust in vaccines, particularly given the general public's limited awareness of technical details," the letter stated.

Abhayrab 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 per cent market share in India.

To reassure healthcare professionals and the public about the product's efficacy, 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 asserted.

Sunil Tiwari, Vice President and Head of Quality Management at IIL, stated that they aim to reassure stakeholders that the company's pharmacovigilance and quality systems are robust, and the public can continue to place confidence in vaccines supplied directly by IIL and its authorised channels.

(With PTI inputs)