New Delhi

Indian Immunologicals Limited (IIL), one of India’s leading vaccine manufacturers, has issued a clarification following recent reports concerning its human anti-rabies vaccine, Abhayrab®.

The company refuted references made in a recent Australian health advisory regarding 2023, stating that these claims do not reflect the current situation. Abhayrab®, manufactured by IIL since 2000, has supplied over 210 million doses across India and 40 other countries, holding a 40% market share in India.

The Australian Technical Advisory Group on Immunisation (ATAGI) noted that counterfeit batches of Abhayrab® had circulated in India since 2023. These fake vaccines differed from the registered product in formulation, packaging, labelling, and manufacturing. Individuals who received such doses may not have been fully protected against rabies and are advised to get replacement vaccinations to ensure proper protection. ATAGI also recommended that travellers to India who received Abhayrab® doses from November 1, 2023, onwards, or are unsure of the vaccine brand, consider re-vaccination.

In January 2025, IIL identified a packaging anomaly in a single batch (Batch # KA 24014). The company immediately informed Indian regulators and law enforcement agencies, lodged a formal complaint, and coordinated closely with authorities. This was an isolated case, and the counterfeit batch is no longer available for sale.

IIL reassured healthcare professionals and the public that all batches manufactured in India are rigorously tested and released by the Central Drugs Laboratory (Government of India) before distribution. Vaccines supplied through government institutions and authorised distributors remain safe and meet all quality standards.

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Sunil Tiwari, Vice President & Head of Quality Management at IIL, stated that the company’s pharmacovigilance and quality control systems are robust, and the public can continue to have confidence in vaccines provided directly by IIL and its authorised channels.