Showing posts with label Knock! Who's There? In India. Show all posts
Showing posts with label Knock! Who's There? In India. Show all posts

Thursday, October 10, 2013

Knock, Knock! Who's There? In India, It's A Surprise Visit From FDA Posted Tue, 10/08/2013 - 10:36am by Ed Silverman


The next time a drugmaker in India hears an unexpected knock at the door, there may be an FDA inspector standing on the other side. Why? The agency is planning to follow the same system of facility inspections in India that is followed in the US and other developed countries, including aggressive surveillance and surprise visits, according to LiveMint.
“India has become a priority location for the FDA as it houses the largest number of FDA-approved drug manufacturing plants outside the US and it is also emerging as the largest exporter of generic drugs to that country,” an unnamed source, who is familiar with agency plans, tells the news site. The surprise visits are being considered because of instances where documents have been fabricated as well as growing concerns about human error in Indian manufacturing units.