Indian drug regulators flag rabies vaccine batch as substandard and potentially counterfeit

…vaccine Abhayrab, and called on authorities to trace the source of vials recently picked up from an “unlicensed” residential location in Delhi, bearing the same brand name and batch number of the original product. “ It is a mandatory practise for vaccines.. every batch gets cleared by the national labs (before release into the market) ,” IIL Managing Director K Anand Kumar told businessline, adding that there were no complaints on their products (Batch KE25012) released only in the local market. IIL was responding to enforcement action by the Central…

…Laboratory, Kasauli, which reported them as “Not of Standard Quality” (NSQ) and misbranded, and the Drug Controller General of India then alerted State regulators on the findings, the CDSCO said. Reiterating that “ the samples under question were not manufactured by Human Biologicals Institute (HBI), IIL’s vaccine division ” - IIL’s Anand said, the Central laboratory had identified 17 differences between the questionable vials and HBI’s retention samples of the same batch that were submitted for batch release. The company’s batch was…