WASHINGTON: Two Indian nationals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution scheme in a US federal court in Florida.
The indictment by a federal grand jury in the Middle District of Florida alleges that Swapandip Roy, Vicky Ramancha, and their co-conspirators sold counterfeit Ozempic to distributors in the United States at deeply discounted prices.
Roy was extradited from Italy to the United States and made his initial appearance in court in Tampa, Florida, on Tuesday.
The duo faces a 71-year jail term if convicted.
According to court documents, beginning in at least July 2023 and continuing to April 2024, Roy and Ramancha allegedly obtained counterfeit Ozempic from unauthorised sources in China.
The counterfeit Ozempic allegedly distributed by Roy, Ramancha, and their co-conspirators included counterfeit packaging, package inserts, pen labels, and needles meant to deceive downstream customers into believing they were purchasing authentic Ozempic authorised by the manufacturer.
The scheme continued even after the FDA seized some of the counterfeit Ozempic in December 2023 and issued a public warning regarding the products.
Roy and Ramancha are charged with one count of conspiracy to commit smuggling and to defraud the United States, three counts of smuggling, and two counts of selling counterfeit drugs and holding counterfeit drugs for sale.
"If convicted, Roy and Ramancha each face a maximum penalty of 71 years in prison," a statement from the Department of Justice said.
"Counterfeit prescription drugs-- especially common ones--threaten the health and safety of every American who depends on the integrity of our pharmaceutical supply," said Assistant Attorney General A.
Tysen Duva of the Justice Department's Criminal Division.
"These defendants allegedly exploited people's health to pay themselves.
We will keep pursuing anyone who seeks to deceive American consumers with counterfeit drugs," he said.
"This indictment reflects our unwavering commitment to protecting Americans from potential harm from counterfeit prescription drugs," said Assistant US Attorney Christopher Murray for the Middle District of Florida.
"Our office will not tolerate bad actors corrupting our pharmaceutical supply chain," Murray said.
"While the US wholesale distribution market is highly regulated, those who choose to subvert the safeguards of the legitimate drug regulatory regime and supply chain by introducing counterfeit drugs into the US market put American consumers at significant risk," said Assistant Commissioner Justin Green of the US Food and Drug Administration Office of Criminal Investigations (FDA OCI).
"Drug safety and quality do not begin or end at the US border.
FDA takes reports of possible counterfeit medicines seriously and works closely with other federal agencies, foreign counterparts, and the private sector to help protect the nation's drug supply," Green said.
The Justice Department's Office of International Affairs secured Roy's continued detention, following his arrest pursuant to an INTERPOL Red Notice, and then timely filed a request for his extradition from Italy.