Two Indian nationals, Swapnadip Roy and Vicky Ramancha, have been charged by a federal grand jury in the Middle District of Florida in the US with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution scheme, the Department of Justice said on Tuesday.
The indictment alleges that Roy, 33, Ramancha, 37, and their co-conspirators sold counterfeit Ozempic to distributors in the US at "deeply discounted prices," the department statement said.
Furthermore, Roy was extradited from Italy to the US and made his initial appearance in Tampa, Florida.
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Counterfeit Ozempic from China
According to court documents, beginning in at least July 2023 and continuing to April 2024, the two Indian nationals allegedly obtained counterfeit Ozempic from unauthorised sources in China, the statement read.
The counterfeit Ozempic allegedly distributed by Roy, Ramancha, and their co-conspirators included counterfeit packaging, package inserts, pen labels, and needles in order to deceive the downstream customers into believing that they were buying authentic Ozempic authorised by the manufacturer.
The department said that the scheme continued even after the Food and Drug Administration (FDA) seized some of the counterfeit Ozempic in December 2023 and issued a public warning about the products.
Charged on counts of smuggling, fraud sale
{{/usCountry}}The department said that the scheme continued even after the Food and Drug Administration (FDA) seized some of the counterfeit Ozempic in December 2023 and issued a public warning about the products.
Charged on counts of smuggling, fraud sale
{{/usCountry}}Roy and Ramancha have been charged with one count of conspiracy to commit smuggling and to defraud the US, three counts of smuggling, and two counts of selling counterfeit drugs and holding counterfeit drugs for sale, the department further said in the statement.
If convicted, Roy and Ramancha each face a maximum penalty of 71 years in prison. FDA OCI is investigating the case, it added.
"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," the statement read.
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Assistant Attorney General A. Tysen Duva of the Justice Department's Criminal Division said that counterfeit prescription drugs threaten the health and safety of American citizens.
"Counterfeit prescription drugs — especially common ones — threaten the health and safety of every American who depends on the integrity of our pharmaceutical supply," Duva said.
"These defendants allegedly exploited people’s health to pay themselves. We will keep pursuing anyone who seeks to deceive American consumers with counterfeit drugs," Duva added.
Assistant US Attorney Christopher Murray for the Middle District of Florida stated, "This indictment reflects our unwavering commitment to protecting Americans from potential harm from counterfeit prescription drugs."
"Our office will not tolerate bad actors corrupting our pharmaceutical supply chain," Murray continued.
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"While the U.S. 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 U.S. market put American consumers at significant risk," said Assistant Commissioner Justin Green of the U.S. Food and Drug Administration Office of Criminal Investigations (FDA OCI).