US regulatory warnings on drug producers extend well beyond India

Hauled up by the US Food and Drug Administration for product recalls and quality issues, Indian pharmaceutical companies are fleeing for cover. Or are they? A closer look will reveal that it is not just Indian drug majors that are under the US FDA scanner, reports The Pharma Letter's India correspondent.

Warning letters about violations have been sent out to drug companies in Australia, Canada, China, Austria, Germany, Netherlands, Ireland, and Spain.

The USA imports around 40% of the finished drugs and nearly 80% of the active pharmaceutical ingredients it needs. Given its rising imports from overseas sources, the FDA has become more vigilant about regulatory adherence.