FDA, Indian Government Stop 500 Illicit Prescription Drug Shipments

The FDA announced that Operation Broadsword, its enforcement operation with the Government of India, stopped nearly 500 shipments of illicit prescription drugs and medical devices from reaching American consumers, according to a recent press release.

The operation targeted packages entering the US through an International Mail Facility from January 28 to January 30, 2020. The drugs on board the shipments were potentially dangerous to consumers and unapproved by the FDA. 

“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,” FDA Commissioner Stephen Hahn, MD, said in a statement. 

In September 2019, a senior level FDA delegation traveled to India to form a partnership with the government in hopes to come together to combat public health- and safety-based crime. 

During Operation Broadsword last month, investigators from both governments examined more than 800 shipments. They found nearly 50 different FDA-regulated products such as medications intended to treat or alleviate serious diseases including cancer and HIV. 

Numerous shipments contained opioid drug products, which had been transshipped through third-party countries to hide the point of origin and avoid detection. 

Across the US, nine IMFs receive mail from more than 180 countries every day. The FDA is focused on inspecting, detecting, and intercepting illegal products like those unapproved, counterfeit, or dangerous to consumers.

Last year, the FDA screened nearly 25,200 parcels containing more than 41,000 products. The agency stopped more than 38,000 of the products and intends to destroy over 17,000 of these products, as drugs subject to the FDA’s administrative destruction authority.

Patients who buy prescription medicines from illegal online pharmacies could be putting themselves at risk because the products may be counterfeit, contaminated, expired, or generally unsafe. These consumers also put themselves at risk of credit card fraud, identity theft, and computer viruses. 

“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," Hahn said. 

The FDA voiced that international law enforcement cooperation is critical in the current systems of distribution. 

“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.