In short
- The defendants allegedly sourced counterfeit Ozempic from unauthorized suppliers in China and distributed it in the U.S. with fake packaging and labels.
- FDA seized some counterfeit Ozempic in December 2023 and issued a public warning, but the scheme continued until April 2024.
What happened
A federal grand jury indicted Swapnadip Roy and Vicky Ramancha for allegedly conspiring to smuggle and distribute counterfeit Ozempic in the United States. The scheme involved sourcing fake drugs from unauthorized suppliers in China and selling them to U.S. distributors at discounted prices, using counterfeit packaging and labels to deceive buyers.
Despite FDA intervention in December 2023, including seizure of counterfeit Ozempic and a public warning, the alleged operation continued until April 2024. Roy was extradited from Italy after his arrest pursuant to an INTERPOL Red Notice, and both defendants face multiple charges with a maximum penalty of 71 years in prison if convicted.
Drug safety and quality do not begin or end at the U.S. 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.
In numbers
- 71 years maximum penalty for each defendant
Named in this item
What compliance teams should check
- Review distributor lists for purchases of Ozempic between July 2023 and April 2024 for links to unauthorized sources in China.
- Check for counterfeit packaging, inserts, pen labels, and needles in Ozempic inventory as described in the DOJ indictment.
- Monitor FDA public warnings and seizure reports from December 2023 for affected products and supply chain vulnerabilities.
Why it matters
This case highlights the risks posed by transnational counterfeit drug schemes to the integrity of the pharmaceutical supply chain. Compliance officers must be vigilant about unauthorized sources, especially for high-demand drugs like Ozempic, and ensure robust controls to detect counterfeit products. The continued operation of the scheme after FDA intervention underscores the need for ongoing monitoring, rapid response to regulatory alerts, and collaboration with law enforcement to protect consumers and uphold regulatory standards.
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