Institute of Good Manufacturing Practices India®

Virtual inspections because of COVID-19 pandemic: Indian pharma industry calls on USFDA


Indian pharma industry urged the US FDA to conduct inspections of their plants and facilities virtually in the wake of the COVID-19 pandemic.

The USFDA, in March, had suspended physical inspections with COVID-19-enforced imperative to protect its personnel and stated towards late July regarding the restart of domestic inspections.  

The virtual inspection may be more challenging for highly toxic products manufactured in contained facilities because of limited visibility of internal infrastructure used despite having windows in place. The additional physical inspection may be done to ensure products' safety, but this could delay the life-saving drugs' approval and launch.

Because of the severity of this pandemic, the agency has proposed many alternative inspection tools such as the summoning of records in advance, product sampling at borders, analysis of a company's compliance history, and use of data shared by other governments as part of mutual recognition and confidentiality agreements.

The appeal by the Indian pharmaceutical industry is worth exploring at this juncture.