Indian companies that supply a quarter of the medicines used in the U.S. must take responsibility for understanding the quality-control rules necessary to export their products, the top U.S. drug regulator said after an eight-day trip to that country.
The visit by Margaret Hamburg, the U.S. Food and Drug Administration commissioner, came amid rising scrutiny of generic drugs made in India after the U.S. banned imports of products in the past nine months from four Indian plants belonging to Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd.. (WPL)
The FDA will expand its offices in India, train Indian regulatory officials and ramp up inspections of overseas plants, Hamburg said in an interview with Bloomberg TV India today. Until recently, she said, the U.S. wasn’t inspecting manufacturers in other countries at the same frequency as in the United States. That’s changing, she said.
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The visit by Margaret Hamburg, the U.S. Food and Drug Administration commissioner, came amid rising scrutiny of generic drugs made in India after the U.S. banned imports of products in the past nine months from four Indian plants belonging to Ranbaxy Laboratories Ltd. (RBXY) and Wockhardt Ltd.. (WPL)
The FDA will expand its offices in India, train Indian regulatory officials and ramp up inspections of overseas plants, Hamburg said in an interview with Bloomberg TV India today. Until recently, she said, the U.S. wasn’t inspecting manufacturers in other countries at the same frequency as in the United States. That’s changing, she said.
continue to read here