An alert was released by the Australian Technical Advisory Group on Immunisation (ATAGI) and state health departments, which warned that travellers who received this vaccine in India since November 1, 2023, may be completely unprotected against the virus.
“Importantly this was an isolated incident,” it said in a statement.
It said that the it had identified the packaging anomaly in January 2025 (batch #KA 24014). The company said that it had notified the Indian regulators and law enforcement agencies, lodged a formal complaint and worked closely with authorities to ensure swift action, it said.
The company strongly refuted the over-cautionary and misplaced reference to 2023 made in a recent Australian health advisory, stressing that the advisory does not reflect the current situation.
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% market share in India.
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,” it further said.
Sunil Tiwari, Vice President & Head of Quality Management at IIL, said that IIL 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 authorized channels.
