New Delhi: For nine months, Indian nationals Swapnadip Roy and Vicky Ramancha allegedly ran a transnational counterfeit Ozempic distribution scheme, sourcing the weight-loss drug from China and selling it in the US even after the Food and Drug Administration (FDA) issued public safety alerts.
A federal grand jury in the Middle District of Florida on Tuesday charged Roy, 33, and Ramancha, 37, who reside in Dubai, with conspiracy and smuggling offences. The indictment alleges that Roy, Ramancha and their co-conspirators sold counterfeit Ozempic to US distributors at “deeply discounted prices”.
Roy was extradited from Italy to the US and made his initial appearance in Tampa, Florida, on Tuesday.
“Defendants Roy and Ramancha distributed counterfeit Ozempic in interstate commerce to customers in the Middle District of Florida and elsewhere in the United States. Roy and Ramancha obtained counterfeit Ozempic from sources in China,” the indictment states. ThePrint has seen a copy of it.
Assistant Attorney General A. Tysen Duva of the US Department of Justice’s Criminal Division 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.”
“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).
According to court documents, Roy and Ramancha allegedly obtained counterfeit Ozempic from unauthorised sources in China from at least July 2023 to April 2024. The scheme allegedly continued even after the FDA seized some of the counterfeit Ozempic in December 2023 and issued a public warning about the products.
Roy and Ramancha are 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. If convicted, each faces a maximum penalty of 71 years in prison.
Ozempic is the brand name of an FDA-approved prescription drug manufactured by Denmark-based Novo Nordisk. It contains semaglutide and is indicated to improve glycaemic control in adults with type 2 diabetes. It is also approved to reduce the risk of major cardiovascular events in adults with type 2 diabetes and known heart disease.
The drug is administered through an injection pen and is available only with a prescription. Although Ozempic is not FDA-approved for weight loss, it is widely used for this purpose and is in high demand in the US.
The products distributed by the duo and their co-conspirators allegedly had counterfeit packaging, package inserts, pen labels and needles designed to make customers believe they were buying authentic Ozempic authorised by manufacturer Novo Nordisk.
“Many units of the counterfeit Ozempic distributed by Roy and Ramancha did not include unique serial numbers,” the indictment states. “Instead, thousands of units displayed false and fraudulent serial numbers on containers that were designed to mimic the packaging manufactured by Novo Nordisk for authentic Ozempic that was lawfully distributed in the United States.” The containers were not manufactured by Novo Nordisk, according to the indictment.
The FDA’s public notification on 21 December 2023 said the counterfeit Ozempic discovered by the agency was labelled with lot number NAR0074 and serial number 430834149057.
Also Read: ‘Just scratching the surface’: How Ozempic maker Novo Nordisk sees India’s GLP-1 market growing
Sales and warnings
The indictment states that on or about 12 July 2023, Ramancha entered into a Sales and Purchase Agreement with Company A, based in Lakeland, Florida, to supply a product described as “Ozempic” at “deeply discounted pricing”.
He entered into a similar agreement with Company B, based in Sanford, Florida, on or about 18 August to supply “Ozempic Syringes” at deeply discounted pricing.
On or about 15 September, Roy and Ramancha allegedly facilitated the shipment of about 47 units labelled as “Ozempic”, bearing lot number NAR0074 and serial number 430834149057, to Company A.
On or about 22 October, Roy allegedly urged Company A to ignore compliance concerns, reminding it that he was obtaining the products “cheap”. The indictment includes chats in which Roy stated: “…see if you want the product cheap, you have to understand that there are some corners being cut…”
The following day, Roy allegedly urged the co-conspirator to disregard concerns about FDA enforcement, saying: “it’s not everyday FDA is going to come and look up your [expletive], you know, it’s fine…”
On or about 1 November, Company A warned Roy and Ramancha that the warehouse storing their products was being audited by the National Association of Boards of Pharmacy (NABP). It wrote: “Jesus the [expletive] NABP is auditing them…”
The indictment states that the company instructed Roy and Ramancha to postpone further deliveries until the audit was completed, saying: “do not deliver the 5 cases until NABP is gone on Friday afternoon.” Ramancha replied: “I am on it.”
On or about 13 November, the company warned Roy to “limit the distribution of the product”, saying: “We can control this process and keep this alive for years but we need to make sure we are air tight. It’s the plant I get it but this lands in the wrong hands and they will go looking.”
Roy responded: “They are already informed on it.” Co-conspirator B said: “Tell them we will bull they have but they can’t do this Fda will shut this down and everyone will be [expletive].”
The indictment also alleges that on or about 15 November, Roy used threats to facilitate distribution of the products in the US. He wrote: “Listen i am not your friend okay? I am not that guy. I am the guy that will cut some one [expletive] head off and [expletive] peoples dead wives corpse with it. You [expletive] up Solve the [expletive] problem Get the truck over there today [sic].”
On or about 19 November, Co-conspirator C warned Ramancha that identical serial numbers appeared on each unit distributed by him and Roy. Co-conspirator C wrote: “All pharmaceutical drugs in the US must be packaged with unique serial numbers, per the 2018 DSCSA requirements.”
Co-conspirator C also warned Ramancha that when a trading partner identifies non-compliance, the products must be quarantined and a report filed with the FDA.
Shortly thereafter in December 2023, the FDA seized some of the counterfeit Ozempic and issued a public warning regarding the products.
(Edited by Chingkheinganbi Mayengbam)
Also Read: Ozempic’s new rival? Meet TOFA, a molecule that ramps up fat burning without eating less