Fake Rabies Vaccine: Global Alarms Ring, Indian Regulator Under Scrutiny | Quick Digest
International health regulators from Australia, the US, and the UK have issued warnings regarding a counterfeit batch of Abhayrab rabies vaccine circulating in India. Despite these global alerts, India's Central Drugs Standard Control Organisation (CDSCO) has been criticized for its delayed and non-public response, raising serious public health concerns. Indian Immunologicals Limited (IIL), the manufacturer, stated they identified the anomaly and informed regulators in January 2025.
Global regulators warned about counterfeit Abhayrab rabies vaccine in India.
Australia, US, and UK issued advisories for travelers since late 2023.
Indian Immunologicals Limited identified fake batch KA24014 in January 2025.
CDSCO criticized for lack of direct public alert despite internal notification.
Counterfeit vaccine poses critical public health risk due to rabies' fatality.
Lack of binding drug recall mechanisms highlights gaps in India's drug safety.
An episode concerning a counterfeit batch of Abhayrab, a rabies vaccine manufactured by India's government-owned Indian Immunologicals Limited (IIL), has prompted urgent warnings from global health regulators, drawing significant attention to India's drug safety and public alert systems. The controversy centers around batch number KA24014, which was found to be counterfeit and potentially circulating in India. IIL stated that it internally detected a packaging anomaly in this specific batch in January 2025 and subsequently informed Indian regulatory and law enforcement agencies, filing a formal complaint.
However, the issue gained international prominence after external regulatory bodies issued advisories. Australia's drug regulator issued a detailed warning on December 19, 2025, cautioning that fake versions of Abhayrab had been circulating in India since late 2023. This advisory recommended that individuals who received rabies vaccinations in India since November 2023 consider replacement doses as a precaution, given the difficulty in distinguishing genuine from counterfeit products.
This was not an isolated incident; the US Centers for Disease Control and Prevention (CDC) reported a rabies case in a traveler returning from India on November 25, 2025, linking it to the circulation of counterfeit Abhayrab. A similar alert was issued by a UK travel health authority on October 29, 2025.
A key point of contention highlighted by news reports is the perceived silence from India's apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO). Public health experts and lawyers have criticized the absence of a direct public alert from either IIL or CDSCO, with India Today's review finding no public warnings on their websites.
While IIL maintained that the counterfeit batch is no longer in circulation and that they proactively engaged with regulators, the lack of a public-facing communication strategy from Indian authorities has raised questions about transparency and accountability in drug oversight, especially since rabies is nearly 100% fatal once symptoms appear. Critics also pointed out that CDSCO's revised drug recall norms, issued in July 2025, remain non-binding guidelines, placing primary responsibility on manufacturers without clearly defining how statutory recalls are enforced or how information is communicated to the public.
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