Wednesday, August 13, 2014

India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ

Read the full article: India Outlines Plan to Boost Inspections of Drug Facilities - Pharmalot - WSJ:

"Last year, the FDA conducted 111 inspections in India, up from 98 in 2011 and 59 in 2009, and has issued warning letters to several Indian drug makers. Significantly, the FDA also issued 21 so-called import alerts that allow the FDA to ban products from entering the U.S.

One widely known example is Ranbaxy Laboratories [500359.BY +1.16%], which is prevented from sending products from four of its plants in India and is also operating under a consent decree that requires improvements before the ban can be lifted. Sun Pharmaceuticals [524715.BY +1.46%] recently agreed to buy Ranbaxy for $3.2 billion"

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