• CORRECTION: This story was updated on March 21, 2014, because it incorrectly quoted Helena Champion, head of the consulting firm Drug Quality Assurance, as saying the European Medicines Agency put 19 Indian companies on a noncompliance list. In fact, she said EMA has posted 30 noncompliance reports involving Indian companies since January 2010.
Volume 92 Issue 8 | p. 6 | News of The Week
Issue Date: February 24, 2014

FDA Head Voices Concerns In India

Pharmaceuticals: On a visit to the country, Hamburg pushes for quality-control cooperation
Department: Business
Keywords: India, drug safety, generics, FDA, GMP, cGMP

During a one-week visit to India, the second-largest foreign supplier of pharmaceuticals to the U.S., FDA Commissioner Margaret A. Hamburg warned pharma executives there that she will not tolerate lapses in drug quality.

“In recent years, FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world,” Hamburg noted in a blog entry made during her trip, which concluded last week. Her message to Indian . . .

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