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India's Drug Regulator Investigates Faulty Rabies Vaccine
5 Sep
Summary
- A batch of widely used rabies vaccine Abhayrab flagged as substandard.
- Previous concerns of counterfeit Abhayrab doses arose less than two years ago.
- The vaccine failed a crucial potency test, raising authenticity questions.
India's drug regulator has identified a batch of the Abhayrab rabies vaccine as substandard and potentially spurious. The Central Drugs Laboratory in Kasauli found that batch KE25012 did not meet potency requirements. This marks the second instance in under two years where concerns have been raised about counterfeit Abhayrab doses in India, a country that reports thousands of rabies deaths annually.
This recent development, detailed in a letter dated August 27, calls for strict vigilance over the vaccine's movement and distribution. The laboratory's findings indicated significant discrepancies in labelling, artwork, and packaging compared to reference samples, questioning the drug's identity and authenticity.
Indian Immunologicals Ltd, the vaccine's supplier, had previously alerted authorities in January 2025 about counterfeit doses of a different batch. Global health bodies had subsequently issued warnings to travellers. The company maintained at the time that it had not manufactured the counterfeit batch and considered the incident isolated.
