19/20 October 2021
In her monthly blog, FDA Commissioner Margaret A. Hamburg gives a personal overview about her recent visit in India. The Federation of Indian Chambers of Commerce and Industries organised roundtable meetings where challenges of Indian pharmaceutical and food exporting companies were discussed. More and more generics are produced in India and quite a few abbreviated new drug applications (ANDA) in the U.S. are still waiting for approval. Margaret A. Hamburg said that FDA is working on reducing the current backlog of generic drug applications. The Generic Drug User Fee Act (GDUFA) supports these actions but does also require and fund more foreign inspections. Companies participating in the roundtable meetings said "they were challenged by our heightened inspectional activities" but Hamburg emphasised that "every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality".
"In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world.", Hamburg said. "This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable."