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Culture Clash: U.S. FDA Tries to Re-educate Indian Firms on Processes And Accurate Reporting

 
• By Cole Werble

FDA has essentially shut down Ranbaxy’s three-year-old facility at Mohali as a source for products for the US market. But Ranbaxy is not alone among Indian firms in its quality product disputes with the agency. There is a significant uptick in activity by FDA in the region in what appears to be a period of intense culturization for the Indian firms into the ways FDA enforces cGMPs and handles on-site inspections.

Ranbaxy Laboratories Ltd. may be getting most of the headlines, but a large portion of the Indian pharmaceutical sector is getting close attention from the Food & Drug Administration, now emboldened and energized with new inspection tools from the FDA Safety & Innovation Act, according to Elsevier Business Intelligence’s RPM Report

Using Warning Letters as a marker for the focus of inspection activity and the locus of problems found, India clearly moved to the top of FDA’s priority list for overseas...

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