Washington: Two Indian nationals have been charged by a US federal grand jury for allegedly smuggling and selling counterfeit Ozempic, a popular prescription medicine used to treat type 2 diabetes and also widely associated with weight management.
The indictment, announced by the US Department of Justice on September 29, alleges that Swapnadip Roy, 33, and Vicky Ramancha, 37, obtained counterfeit Ozempic from unauthorised sources in China and sold the products to distributors in the United States at deeply discounted prices. The alleged scheme operated between July 2023 and April 2024.
The case involves allegations of an international counterfeit-drug distribution network and has prompted concerns from US authorities about the risks posed by fake medicines entering the country’s regulated pharmaceutical supply chain.
Fake Ozempic allegedly made to look authentic
According to US court documents, the counterfeit products allegedly contained packaging, package inserts, pen labels and needles designed to make them appear to be genuine Ozempic authorised by the manufacturer.
Prosecutors allege that Roy, Ramancha and their co-conspirators supplied the counterfeit products to distributors in the US at significantly reduced prices. The products were allegedly intended to deceive downstream buyers, including those who could ultimately have supplied them to pharmacies or patients.
The alleged activity continued even after US authorities seized some of the counterfeit Ozempic in December 2023 and the US Food and Drug Administration (FDA) issued a public warning about the products, according to the indictment.
The FDA said its Office of Criminal Investigations assisted in the investigation.
One accused extradited from Italy
Roy has been extradited from Italy to the United States and appeared in federal court in Tampa, Florida, on September 29. He pleaded not guilty, according to the US Department of Justice and Reuters.
Ramancha remains at large, according to US authorities. The Justice Department’s Office of International Affairs said Roy had earlier been arrested pursuant to an INTERPOL Red Notice before US authorities secured his extradition from Italy.
The defendants are facing one count of conspiracy to commit smuggling and defraud the United States, three counts of smuggling, and two counts related to selling and possessing counterfeit drugs for sale. If convicted on all charges, each could face a maximum combined penalty of 71 years in prison.
The potential sentence is the maximum provided under the charges and does not mean that either defendant will necessarily receive that sentence.
FDA warns about counterfeit medicines
US authorities have stressed that counterfeit prescription medicines pose risks to patients because their contents, strength, quality and manufacturing conditions may not meet regulatory standards.
Assistant Commissioner Justin Green of the FDA’s Office of Criminal Investigations said that people who bypass the legitimate pharmaceutical supply chain by introducing counterfeit medicines into the US market can put consumers at significant risk. The agency said it works with federal authorities, foreign counterparts and private-sector partners to investigate suspected counterfeit medicines.
The FDA had already issued safety alerts concerning counterfeit Ozempic products beginning in December 2023. Those warnings followed the seizure of some counterfeit products, which prosecutors now allege did not stop the defendants’ distribution activities.
What is Ozempic?
Ozempic is a semaglutide-based prescription medicine manufactured by Novo Nordisk. It is authorised in the US for adults with type 2 diabetes, alongside diet and exercise, to improve blood sugar control and reduce certain cardiovascular risks in eligible patients.
The medicine has also become widely known because of the broader popularity of GLP-1 medicines for weight management. This has contributed to strong demand and made the products a target for counterfeiters.
The US case concerns allegedly counterfeit products and should not be interpreted as a finding that genuine Ozempic manufactured and distributed through authorised channels is counterfeit or unsafe.
Charges remain allegations
The US Department of Justice has emphasised that an indictment is an allegation and that both defendants are presumed innocent unless proven guilty beyond a reasonable doubt in court.
The case is being investigated by the FDA’s Office of Criminal Investigations. Assistant US Attorney Ross Roberts and Trial Attorney Peter Leininger are prosecuting the matter, according to the Justice Department.
The investigation highlights the international nature of counterfeit pharmaceutical trafficking, with the alleged products sourced in China, defendants who are Indian nationals and US distributors forming part of the alleged supply chain.
As the case proceeds, US authorities will seek to establish the extent of the alleged distribution network and the role played by the two defendants. The proceedings will also determine whether the allegations contained in the indictment can be proved in court.