The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January. “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 M. Hahn, M.D. “The FDA is committed to empowering patients and providing them with a choice, but also protecting them through collaboration with our international regulatory and law enforcement partners. It is vital that we aggressively stop illicit products from entering the country that may place patients’ health at risk, and we are pleased to call the Government of India a partner in this effort.”
