FDA and Indian Government Stop Illicit Medical Products From Reaching Consumers

Operation Broadsword, was the agency’s first bilateral enforcement operation with the Government of India.

The FDA today announced that approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices were stopped from reaching consumers in the United States during an operation that took place in January. The effort, Operation Broadsword, was the agency’s first bilateral enforcement operation with the Government of India.

Standards and regulations for medications and health care products vary by country. According to FDA Commissioner Stephen M. Hahn, MD, consumers in the United States face hazards when ordering drugs and medical products from foreign sources that are not regulated by the FDA. In Tuesday’s announcement, Hahn said consumers and physicians cannot be assured that the products they receive from these unauthorized sources are legitimate, safe, or effective.

“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,” said Hahn, in a prepared statement.

Patients that buy prescription medicines from illegal online pharmacies may be putting their health at risk because the products, while being passed off as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe. In addition to health risks posed by these products, illegal online pharmacies can pose other risks to consumers. These include the risk of credit card fraud, identity theft and computer viruses, according to the FDA.

Operation Broadsword targeted packages entering the US through an International Mail Facility (IMF) from January 28, 2020 through Jan. 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 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 800 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, according to the FDA.

In its statement, the FDA said it believes international law enforcement cooperation is essential in the age of interconnected regulatory frameworks and systems of distribution. In September 2019, 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.

“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,” said Balesh Kumar, director general, Directorate of Revenue Intelligence for the Government of India, in a prepared statement. “Such an exercise also has potential for long term capacity building. The Directorate of Revenue Intelligence is committed to fighting the menace of drugs and narcotics and international cooperation with agencies like the US FDA can help us in our efforts towards this cause.”

Each day in the US, 9 IMFs receive mail from more than 180 countries, and the FDA is tasked with inspecting, detecting and intercepting 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 agency 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.

REFERENCE

FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products [news release]. Silver Spring, MD; February 18, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/fda-takes-action-indian-government-protect-consumers-illicit-medical-products. Accessed February 18, 2020.