India's central drug regulatory body has issued an alert regarding a batch of the popular Abhayrab rabies vaccine, classifying it as substandard and potentially spurious. The directive follows a potency test failure at the government's Central Drugs Laboratory in Kasauli, intensifying fears about the authenticity and quality of critical vaccines distributed across the nation.
According to a government document reviewed by Reuters, India’s Drugs Controller General, Rajeev Singh Raghuvanshi, instructed state drug regulators on August 27, 2026, to maintain stringent oversight over the movement of Abhayrab batch number KE25012. Regulatory action is advised for any necessary interventions.
Packaging Discrepancies Fuel Spurious Drug Fears
While the field sample of batch KE25012 met sterility, moisture, and identity standards, laboratory officials uncovered significant discrepancies when comparing it against a reference sample previously submitted by a division of Indian Immunologicals. These critical differences included variations in labeling, artwork, QR-code verification, cap color, license details, and packaging text.
These inconsistencies have raised serious questions about the product's true identity, prompting authorities to investigate whether the sample constitutes a spurious drug under India’s Drugs and Cosmetics Act.
Second Incident in Two Years
This alert marks the second time in less than two years that suspect Abhayrab doses have surfaced in India. In January 2025, Indian Immunologicals had informed the drug regulator about counterfeit doses (batch number KA24014) circulating in the market. That previous incident led to health advisories being issued by authorities in the United States, Britain, and Australia for travelers who might have received the vaccine in India.
Indian Immunologicals, a major player in India's rabies vaccine market with approximately 40% share, has supplied over 210 million doses of Abhayrab both domestically and internationally over two decades. The vaccine is crucial for government immunization programs, offering both pre- and post-exposure protection against rabies. India experiences an estimated 5,726 human rabies deaths annually, underscoring the vital importance of reliable vaccine supply.
The government document did not specify the number of doses distributed from batch KE25012, nor did it clarify if any doses were exported or if international regulators have been notified. Indian Immunologicals exports Abhayrab to over 40 countries, including South Africa, Turkey, Vietnam, and the United Arab Emirates.