In a first of its kind of joint operation, India and the US stopped about 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from entering America in January, the US Food and Drug Administration said on Tuesday.
Operation Broadsword targeted packages entering the US through an International Mail Facility (IMF) from January 28 through January 30, it said.
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 drugs products, had been transshipped through third-party countries to conceal their point of origin and avoid detection. Health risks are further compounded when products are sent through such third-party countries, which undermines protections afforded via regulated pharmaceutical supply chains, the FDA said.
"A bilateral enforcement exercise like Operation Broadsword allows us to closely work with our US 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.
With standards and regulations varying in each country, US consumers face hazards when they order drugs and other FDA-regulated products from unauthorized foreign sources and receive them through the international mail system, said FDA Commissioner Stephen M Hahn.
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, he said.
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 India's Central Board of Indirect Taxes and Customs and Directorate of Revenue Intelligence and US Customs and Border Protection.
