FDA and India prevented 500 unapproved drug shipments entering US in January

The US Food and Drug Administration (FDA) has announced that the 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 entering the US over the course of an operation that took place in January.

Operation Broadsword targeted packages entering the US through an International Mail Facility (IMF) from 28 January to 30 January. 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 the operation, 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, says the FDA, which included opioid drug products, had been shipped through third-party countries to conceal their point of origin and avoid detection. 

“With standards and regulations varying in each country, US consumers face hazards when they order drugs and other FDA-regulated products from unauthorised 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 Dr Stephen Hahn. “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.”

“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 of the Directorate of Revenue Intelligence for the Government of India. 

The FDA says that patients who buy prescription medicines from illegal online pharmacies may be purchasing counterfeit, contaminated, expired or otherwise unsafe medicines. Illegal online pharmacies can also pose the risk of credit card fraud, identity theft and computer viruses.

In the 2019 fiscal year, the FDA screened approximately 25,200 parcels, containing more than 41,000 products combined at all of its IMF facilities. The agency detained more than 38,000 of those products and expects to ultimately destroy more than 17,000.