Customs Cleared, Charges Pending: Counterfeit Ozempic Indictment Makes the Drug Supply Chain Security Act (DSCSA) an Import Compliance Issue

Key Takeaways

• A federal grand jury in Tampa returned an indictment charging two foreign nationals with conspiracy in connection with an alleged scheme to import and sell counterfeit Ozempic sourced from China and to defraud the United States, as well as with smuggling, and selling counterfeit drugs.
• The US Department of Justice (DOJ) used circumvention of the Drug Supply Chain Security Act’s (DSCSA) documentation and serial number requirements as the basis for the smuggling charges that carry up to 20 years per count.
• Like the Safe Chain convictions last year, the case shows prosecutors using the failure to adhere to the DSCSA’s requirements as a benchmark for establishing liability.

What Happened

On September 29, the DOJ announced a federal indictment (unsealed on June 9) in the Middle District of Florida — United States v. Roy, No. 8:25-cr-00438 (M.D. Fla.) — charging two Dubai-based Indian nationals, Swapnadip “Eric” Roy and Vicky Ramancha, with smuggling counterfeit Ozempic into the United States and selling it. Roy was arrested in Italy on an INTERPOL Red Notice and extradited to Tampa; Ramancha has yet to appear in the case and reportedly remains at large. According to news reports, Indian authorities have opened a parallel investigation tied to approximately 125,000 counterfeit doses.

As alleged in the indictment, from July 2023 through April 2024, the defendants obtained product labeled “Ozempic” from sources in China that Novo Nordisk had not authorized, in counterfeit containers with fake labels and needles meant to deceive downstream customers that they were buying authentic Ozempic, and together with their co-conspirators, sold it at deeply discounted prices to US distributors. Even after the US Food and Drug Administration (FDA) issued a public safety alert about a counterfeit lot in December 2023 and seized product from US warehouses, the defendants’ scheme allegedly continued. The indictment charges conspiracy to smuggle goods into the United States and to defraud the lawful functions of the FDA (in violation of 18 U.S.C. § 371), three counts of smuggling (in violation of 18 U.S.C. § 545), and two counts of selling counterfeit-drugs and holding counterfeit drugs for sale (in violation of 21 U.S.C. §§ 331(i)(3), 333(a)(2)).

The DSCSA as the Basis for Criminal Charges

The indictment does not bring a standalone charge under the DSCSA (21 U.S.C. § 360eee et seq.). Instead, it uses the DSCSA as a building block for other counts, alleging that the defendants conspired to smuggle, and did smuggle, into the United States product labeled as Ozempic, contrary to the documentation and unique serial number requirements of the DSCSA. One co-conspirator allegedly flagged the duplicate serial numbers to Ramancha, warning that “[a]ll pharmaceutical drugs in the US must be packaged with unique serial numbers, per the 2018 DSCSA requirement,” and that trading partners must quarantine suspect product and report it to the FDA on Form FDA 3911. In response, Ramancha allegedly forwarded a warning to several individuals, including that co-conspirator, urging, “we have to make sure who ever you are engaging with is under NDA and keeps their mouth shut and dosent make any headache going to fda…” 

Because violations of the DSCSA constitute “prohibited acts” under § 331 of the Food, Drug & Cosmetics Act (FDCA) (21 U.S.C. 301 et seq.), failing to adhere to its requirements can be charged criminally through the FDCA, as either a strict liability misdemeanor for a basic violation, or as a felony in the case of a repeat violation or a violation committed with intent to defraud or mislead. However, the requirements of the DSCSA referenced in the indictment apply to manufacturers, wholesalers, dispensers, and repackagers, and the defendants’ roles are not pleaded as any. The core conduct alleged is counterfeiting and smuggling. What the DSCSA provided was a clear, objective benchmark. Its documentation and serial number requirements gave prosecutors the “contrary to law” element for the smuggling counts and evidence of a co-conspirator’s alleged warning that the product would not pass muster constitutes one of the overt acts in furtherance of the conspiracy count. 

The Customs and Trade Angle 

The DOJ charged the importation under the second paragraph of 18 U.S.C. § 545, which reaches anyone who fraudulently or knowingly imports merchandise “contrary to law,” or who receives, conceals, buys, sells, or facilitates the transportation, concealment, or sale of such merchandise knowing it was imported contrary to law. Each count carries up to 20 years. The indictment does not allege false declarations to US Customs and Border Protection (CBP), misclassification of the tariff code, or undervaluation of the products. The “law” the product allegedly violated is the DSCSA’s manufacturer documentation and product-identifier requirements. DSCSA compliance can now be an import compliance issue. Customs release is not a safe harbor: release by CBP is not a determination that goods were lawfully imported, and § 545 liability and forfeiture can follow the goods after entry. The government is seeking forfeiture of the merchandise, proceeds, and substitute property.

The Bigger Picture: What Companies Should Take From This

For FDA compliance: the DSCSA supplied the standard. It is worth being precise about the DSCSA’s role here. The alleged criminal conduct was not violating the DSCSA — it was smuggling and counterfeiting. Notably, the alleged conduct took place in 2023 and early 2024, before the FDA’s stabilization period and exemptions for the DSCSA’s enhanced electronic tracing requirements ended for manufacturers, wholesalers, and large dispensers in 2025. The Safe Chain case followed a similar pattern. Falsified transaction documents were central to the proof, and a jury last year convicted co-owners Patrick and Charles Boyd of misbranding, wire fraud, and trafficking in medical products with false documentation, not of DSCSA violations as such (United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.)). The takeaway is measured but real. Enforcers appear to be using the DSCSA’s requirements as a yardstick for what a legitimate transaction looks like. For companies acting in good faith, that works in their favor: complete transaction records and a documented suspect product process are the clearest evidence that they did what the law expects. And as package-level electronic data becomes routine, gaps and inconsistencies in that data will be easier for everyone, including regulators, to spot. 

For importers and their downstream partners: diligence belongs upstream. Because § 545 reaches anyone who knowingly receives, buys, sells, or helps move improperly imported goods, the risk extends past the importer of record to distributors, warehouses, and logistics providers. Trading partners sourcing prescription drugs from abroad should complete DSCSA diligence (traceability to an authorized source and product identifiers that match the physical goods) before purchase and entry, not after release. 

For compliance and legal teams: red flags leave a trail. Many of the red flags in this case surfaced in messages among people inside the scheme: a price too good to be true, every unit bearing the same serial number, a delivery timed to dodge an auditor, a request to keep quiet. A company that sees signs like these and keeps buying may invite scrutiny of its own conduct. The safest response is the one the DSCSA already requires: quarantine the product, investigate, and report when warranted. A company that does this, and documents it, creates the best record of its own good faith — which is exactly what it will want if investigators ever come asking.

For questions about how these developments may affect your business, please contact the authors.