FDA teams up with Indian government to crack down on illicit drugs shipments
pharmafile | February 19, 2020 | News story | Research and Development | FDA, FDA India, FDA trade, Indian Pharma
The FDA announced yesterday its first successful bilateral enforcement operation with the Government of India, where they stopped 500 shipments of illicit unapproved prescription drugs and medical devices from reaching America.
Operation Broadsword targeted packages entering the US through an International Mail Facility from 28 January through 30 January. It 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.
FDA Commissioner Stephen M. Hahn, commented on the operation, and said: “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.”
During the operation, both governments examined more than 800 shipments and identified more than 50 different FDA-regulated products including Cancer and HIV drugs. Many of the shipments also included opioids. They often transported the drugs through third-party countries to conceal their point of origin and avoid detection. This also undermines protections that are applied through pharmaceutical supply chains.
Balesh Kumar, Directorate of Revenue Intelligence for the Government of India, said: “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. Such an exercise also has potential for long term capacity building.”
This new collaboration began in September, when a senior-level FDA delegation travelled 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 U.S. Embassy in New Delhi.
Conor Kavanagh
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