- Because of the explosion of marketing applications coming from Indian pharma companies, the U.S. FDA will now have 19 on-the-ground inspectors, up from nine or ten.
- India's government inspectors will be invited to attend inspections along with the U.S. inspectors.
- Inspectors don't just inspect facilities—they're also responsible for accrediting clinical trials.
At face value, the deployment of additional inspectors may seem more related to the need for additional oversight due to quality-control issues.
But Solomon Yinman, assistant country director for the FDA India Office, asserts that this is not the case. According to Yinman, it all comes down to an increase in marketing applications and the need to build capacity.