By Rishika Sadam
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. The regulator said the findings raised concerns about the sample’s “identity and authenticity” and warranted investigation into whether it could be a spurious drug under India’s Drugs and Cosmetics Act.
moisture and identity tests, the laboratory also found significant differences between the sampled product and a retained reference sample of the same vaccine previously submitted by a division of Indian Immunologicals for regulatory testing While the sample passed sterility.
