India’s drug regulatory authority has issued a formal warning regarding a specific batch of the widely distributed rabies vaccine, Abhayrab, labeling it as substandard and potentially counterfeit. The concern arose after batch KE25012 failed essential potency tests conducted by the Central Drugs Laboratory in Kasauli. While the vaccine passed safety checks for moisture and sterility, investigators discovered alarming discrepancies between the field sample and official reference products, including inconsistencies in packaging, QR codes, and cap coloring. Consequently, the Drugs Controller General has urged state regulators to exercise heightened vigilance and investigate the distribution of this batch.

This incident marks the second time in under two years that fake Abhayrab doses have been identified in the Indian market, raising significant public health concerns in a country that experiences thousands of rabies-related deaths annually. Indian Immunologicals Ltd, a major player in the domestic market, has yet to comment on the findings. Given that Abhayrab serves as a critical frontline defense against the nearly fatal virus, the potential circulation of spurious doses poses a severe threat to immunization programs. Authorities are now moving to determine the extent of the distribution, though it remains unclear how many doses of this specific batch may have reached patients or entered the supply chain.