USFDA to up its India head count, denies targeting cos

The Dollar Business Bureau The USFDA, which has offices in New Delhi and Mumbai, is in the process of increasing its headcount in India to 19. Solomon Yimam, Assistant Country Director, USFDA India Office while denying that the inspections are targeted, said the frequency of audits of Indian facilities would depend on the number of product applications filed from that facility. "USFDA is in the process of taking the headcount up to 19. We have offices in New Delhi and Mumbai. We are in the process of bringing more (officials). Currently we have 9 or 10 (officials working in India)," Yimam said during an interactive session at BioAsia-2015. "First of all inspections are driven by marketing applications. So depending on the number of marketing applications (of products) we do the inspections. The target is depending on how many companies are producing new products for USA.” He added. "There are three ways of inspections. One is for marketing application. The second one (inspection) will be if there is a complaint then we will do that. The frequency depends on what type of inspection we will conduct," the USA official said. He said the idea of inviting host-country regulators during FDA inspections is to make them understand the process of FDA audits.  

This article was published on February 4, 2015.