World · India Bureau
Drug regulator investigates suspected counterfeit rabies vaccine batch
Indian drug authorities have launched a probe into a potentially counterfeit rabies vaccine after laboratory tests revealed compromised potency. The manufacturer has denied responsibility for the suspect batch, which failed critical safety checks.
LSN India ·
Regulatory authorities are investigating a batch of rabies vaccine suspected to be counterfeit or misbranded after it failed potency testing at the Central Drugs Laboratory. The batch in question, identified by number KE25012, did not meet the required efficacy standards during laboratory analysis, triggering an official inquiry into its origins and distribution.
The manufacturer associated with the batch has issued a denial, claiming it did not produce the vials bearing the disputed batch number. This contradictory claim has added complexity to the investigation as authorities attempt to determine whether the vaccine is counterfeit, misbranded, or subject to storage or handling issues that compromised its potency.
The discovery comes amid ongoing concerns about the circulation of substandard or falsified medicines in India's pharmaceutical supply chain. Rabies vaccines are critical public health commodities, as the virus is almost uniformly fatal once symptoms develop, making vaccine quality paramount for post-exposure prophylaxis.
Drug regulators have not yet disclosed the extent of the batch's distribution or whether any adverse events have been reported in connection with its use. The investigation is expected to determine the batch's geographic reach and whether a broader recall may be necessary. Authorities have urged healthcare facilities and vaccination centers to exercise caution regarding the batch number and to report any suspected cases of vaccine-related complications.