This is becoming a bit monotonous lately but another drug plant in India has been put on FDA's banned list or "red list" forbidding it from sending imports to the US until cleared for quality. This time we have a Sun Pharmaceuticals plant making generic cephalosporin antibiotics. In the very recent past, Ranbaxy has had ALL 4 of its Indian plants cited and two more plants have been hit under Wockhardt's ownership. In all, there are 33 manufacturing plants in India on FDAs watch list.
But to add a little more perspective, there are 31 plants from China on the List. And, even Germany has 8 plants that are listed. But keep in mind that India is the second largest supplier of over the counter and prescription drugs to the US, falling right behind Canada. So, this isn't a trivial issue. FDA Commissioner Margaret Hamburg visited India last month partially in response to this issue. The FDA says it plans to add more inspectors to India and to tighten rules on how they regulate the generic industry. This is all to restore confidence by US consumers. See Bloomberg and inPharma Technologist.
Posted by Bruce Lehr Mar 13th 2014.