India and the FDA has sometimes had a strained relationship given how often the agency has come down on Indian drugmakers for manufacturing lapses. Now, in a first, the FDA and Indian oversight agencies worked together to block illegal drugs from entering the U.S.
In what was termed Operation Broadsword, the Government of India’s Central Board of Indirect Taxes and Customs and Directorate of Revenue Intelligence joined the FDA and other U.S. enforcement agencies for three days examining 800 shipments, looking for illegally shipped drugs.
The effort uncovered 50 different FDA-regulated products, including medications for treating HIV and various forms of cancer, as well as opioids. Many of the shipments had been transshipped through third-party countries to conceal their point of origin and escape detection, the FDA said.
“With standards and regulations varying in each country, U.S. 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 M. Hahn said in a statement.
“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 continued.
The FDA stepped up its intervention efforts some years ago after finding that some cancer doctors had been acquiring drugs illegally shipped from India, Turkey and Pakistan and sold at deep discounts.
For India, it was a chance to form a working bond and learn about how the FDA intercepts imported drugs from India and elsewhere.
“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,” Balesh Kumar, director general, Directorate of Revenue Intelligence for the Government of India, said in the announcement.
The operation in January was preceded by a series of meetings last fall at the U.S. Embassy in New Delhi between “senior-level” FDA officials and government officials in India.
The FDA said that in fiscal 2019, the agency screened approximately 25,200 parcels, containing more than 41,000 products combined at all of its international mail facilities. The FDA detained more than 38,000 of those products, and expects to ultimately destroy more than 17,000 of them.
Feb 19, 2020