GESTIÓN EN SALUD PÚBLICA: FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

domingo, 23 de febrero de 2020

FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

https://www.fda.gov/news-events/press-announcements/fda-takes-action-indian-government-protect-consumers-illicit-medical-products?utm_campaign=021820_PR_FDA%20Launches%20First%20Bilateral%20Operation%20to%20Prevent%20Import%20of%20Illicit%20Medical%20Products&utm_medium=email&utm_source=Eloqua

FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

First Bilateral Enforcement Operation with India Stopped Approximately 500 Shipments Through International Mail

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 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.”

Operation Broadsword targeted packages entering the U.S. through an International Mail Facility (IMF) from Jan. 28 through Jan. 30. The operation was a collaboration between the FDA’s Office of Regulatory Affairs, Office of Criminal Investigations, Forensic Chemistry Center and Division of Northern Border Imports along with the Government of India’s Central Board of Indirect Taxes and Customs and Directorate of Revenue Intelligence and U.S. Customs and Border Protection.

During Operation Broadsword, investigators from both governments examined more than 800 shipments, which identified approximately 50 different FDA-regulated products, including medications intended to treat and ...