Questions raised over delay in alert on fake anti-rabies vaccine

Anger is rising over India’s drug regulators for failing to issue a public advisory on counterfeit Abhayrab rabies vaccines. Despite alerts from Indian Immunologicals Limited, authorities chose a quiet probe, prompting ethical concerns after global warnings were issued by foreign regulators.

Hyderabad: Anger is mounting over the failure of the country’s drug regulators to issue a timely public advisory regarding counterfeit versions of the life-saving anti-rabies vaccine, Abhayrab.

In January 2025, the Hyderabad-based manufacturer Indian Immunologicals Limited (IIL) blew the whistle, identifying a counterfeit batch (KA24014) with tampered packaging. While IIL maintained that it immediately notified the Central Drugs Standard Control Organisation (CDSCO) and law enforcement agencies, the government opted for a quiet investigation rather than a public advisory.

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The issue came into public focus a few days ago when authorities in Australia, the US and the UK issued global alerts, warning that vaccines circulated since 2023 might be ineffective.

Pediatrician Dr Sivaranjani Santosh has been vocal about the ethical lapse and said, “Rabies is a fatal disease. People had a right to know about the possibility of having received a counterfeit version. According to me, it is criminal not to have alerted us.”

While IIL reported the fraud to CDSCO, the drug regulatory authorities did not issue any advisory to the general public and instead issued an internal advisory and a ‘take action’ notice to State drug control administrations to crack down on the issue and streamline rabies vaccine availability.

The lack of an official look-back exercise in India, similar to those conducted by the UK’s NHS, has been termed a massive failure of institutional ethics. With no statement on the issue from the Health Ministry, confusion continues over the status of the rabies vaccine.