- India flags potentially spurious batch of Abhayrab vaccine
- Rabies vaccine batch fails potency test, prompting probe HYDERABAD, Sept 4 – India’s drug regulator has flagged a batch of widely used rabies vaccine Abhayrab as substandard and potentially spurious after it failed a potency test, a government document seen by Reuters shows. The finding marks the second time in less than two years that concerns have been raised about counterfeit Abhayrab doses in India, a country that reports nearly 6,000 rabies deaths a year and where the vaccine is a frontline defence against the otherwise nearly always fatal infection. Indian Immunologicals Ltd has supplied more than 210 million doses of Abhayrab in India and other countries for over two decades and held a 40% share of the domestic rabies vaccine market, it said in December.
In an August 27 letter to state drug regulators, India’s Drugs Controller General Rajeev Singh Raghuvanshi asked officials to maintain “strict vigilance” over the movement and distribution of Abhayrab batch KE25012 and take regulatory action, as necessary. The action came after the government’s Central Drugs Laboratory in Kasauli found that a field sample of the vaccine did not meet potency requirements and classified it as “not of standard quality” and a “misbranded” drug, according to the document.
Discrepancies Found in Vaccine Testing Results
Recent laboratory tests confirmed that while the vaccine sample met sterility, moisture, and identity standards, it exhibited notable differences when compared to a retained reference sample. This reference sample was previously submitted for regulatory testing by a division of Indian Immunologicals. The findings raise questions about the consistency and reliability of the vaccine’s formulation.
