FDA, Gov’t of India Partner in Enforcement Operation Against Unapproved Rx DrugsBy
The US Food and Drug Administration (FDA) reports that its first bilateral enforcement operation with the Government of India stopped approximately 500 shipments of illicit and unapproved prescription drugs and combination medical devices over the course of an operation that took place in January 2020.
The bilateral enforcement exercise, Operation Broadsword, targeted packages entering the US through an International Mail Facility (IMF) from January 28 through January 30, 2020. 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 US 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 or mitigate serious diseases, such as various forms of cancer and HIV. Many of the shipments, which included opioid-drug products, had been transshipped through third-party countries to conceal their point of origin and avoid detection.
The basis for Operation Broadsword dates back to September 2019, when a senior-level FDA delegation traveled to India for the purpose of strengthening bilateral engagement. A series of stakeholder meetings—coordinated and facilitated by the India Office of the FDA’s Office of Global Policy and Strategy—were held at the US Embassy in New Delhi as well as with the Government of India’s Central Board of Indirect Taxes and Customs, the Directorate of Revenue Intelligence, and the Central Drug Standard Control Organization in support of an ongoing bilateral initiative to combat public health and safety-based crime.
Overall, nine IMFs in the US receive mail from more than 180 countries, and it is part of the FDA’s activities to inspect, detect and intercept illegal products, including those that are unapproved, counterfeit and/or potentially dangerous, such as illicit opioid products, counterfeit prescription drugs, medical devices, over-the-counter products, and products labeled as dietary supplements that may contain harmful ingredients. In fiscal year 2019, the FDA screened approximately 25,200 parcels, containing more than 41,000 products combined at all of its IMF facilities. The FDA detained more than 38,000 of those products, and expects to ultimately destroy more than 17,000 of those products as drugs subject to the FDA’s administrative destruction authority.
Source: US Food and Drug Administration