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FDA, India Govt Stop 500 Shipments Of Illicit Medical Products

medicalproducts feb19 lt

The U.S. Food and Drug Administration said its first bilateral enforcement operation with India, stopped about 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and medical devices from reaching American consumers.

"With standards and regulations varying in each country, U.S. consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international mail system. 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

Operation Broadsword targeted packages entering the U.S. through an International Mail Facility from January 28 through January 30.

During Operation Broadsword, investigators from both governments examined more than 800 shipments, which identified about 50 different FDA-regulated products, including medications intended to treat and or mitigate serious diseases, such as various forms of cancer and HIV.

Many of the shipments, which included opioid drugs products, had been transshipped through third-party countries to conceal their point of origin and avoid detection.

"A bilateral enforcement exercise like Operation Broadsword allows us to closely work with our U.S. counterparts so as to share best practices, develop intelligence, better target suspect consignments, consignors and other bad actors at both ends," said Balesh Kumar, director general, Directorate of Revenue Intelligence for the Government of India.

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