FDA, India collaborate to stop unapproved medical products

The Food and Drug Administration, in its first enforcement operation with the government of India, recently stopped about 500 shipments of unapproved prescription drugs and combination medical devices from reaching U.S. consumers, the agency announced today. The shipments, many sent through third-party countries to conceal their origin, included about 50 FDA-regulated products, including cancer and HIV medications and opioid products, FDA said. “Consumers and physicians purchasing medicines cannot be assured the products they are receiving are legitimate, safe or effective if they are obtained from outside of the FDA-regulated pharmaceutical supply chain,” said FDA Commissioner Stephen Hahn, M.D.