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India flags Abhayrab rabies vaccine batch KE25012 as substandard
The Hindu BusinessLine··5 Sept
India's drug regulator flagged Abhayrab rabies vaccine batch KE25012 as substandard and potentially spurious after a potency test failure, a Reuters-seen document shows. Drugs Controller General Rajeev Singh Raghuvanshi asked states on August 27 to maintain strict vigilance over the batch. India reports nearly 6,000 rabies deaths a year. This is the second counterfeit concern in less than two years.
Prism
What It Means For You
- Patients who received doses from batch KE25012 may need clinics to verify batch numbers against state alerts.
- Rabies infection is nearly always fatal without timely vaccination after exposure.
- India records an estimated 5,726 human rabies deaths annually, government data show.
What's Happening
- Central Drugs Laboratory in Kasauli classified the sample as not of standard quality and misbranded.
- Labelling, artwork, QR codes and cap colour differed from a retained reference sample.
- Indian Immunologicals supplied over 210 million Abhayrab doses and held 40% of India's market.
India's Rabies Vaccine Supply Chain
- Counterfeit Abhayrab batch KA24014 prompted US, British and Australian travel alerts in 2025.
- The company said in January 2025 it had not manufactured that counterfeit batch.
- State drug regulators were told to take regulatory action over batch KE25012 as needed.
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