Exclusive-India flags Abhayrab rabies vaccine batch as substandard, probes if spurious, document shows

India's drug regulator has raised concerns about a batch of the widely used rabies vaccine Abhayrab, questioning its potency and authenticity. The government document, seen by Reuters, reveals that a sample of the vaccine failed a potency test, leading the regulator to classify it as substandard and potentially a counterfeit drug.

This marks the second time in less than two years that issues have been raised regarding counterfeit Abhayrab doses in India, a country that experiences nearly 6,000 rabies deaths annually. Indian Immunologicals Ltd, the manufacturer, holds a 40% share of the domestic rabies vaccine market and has supplied over 210 million doses of Abhayrab since its introduction over two decades ago.

The regulator, India's Drugs Controller General Rajeev Singh Raghuvanshi, requested state drug regulators to closely monitor the distribution of the suspect batch KE25012 and take necessary regulatory action. The investigation was prompted by discrepancies in labelling, artwork, QR code verification, cap colour, licence details, and packaging text between the tested sample and a previously submitted reference sample.

The regulator found no issues with sterility, moisture, or identity tests, but raised concerns about the sample's identity and authenticity, warranting further investigation under India's Drugs and Cosmetics Act. Indian Immunologicals and the federal regulator have not commented on the matter. This is not the first time counterfeit doses of Abhayrab have been flagged; in January 2025, the company had informed Indian regulators about a counterfeit batch with batch number KA24014.

Global health authorities in the US, UK, and Australia had previously issued alerts to travellers who may have received the vaccine in India. However, Indian Immunologicals denied involvement in the counterfeit production and stated it was an isolated incident. The government document does not disclose the number of doses from the flagged batch that may have been distributed or exported.