Originally published on Medium.
A federal indictment lists what it took to counterfeit an injectable: packaging, inserts, pen labels and needles, sourced from China. Britain approved a semaglutide tablet in June. Half of that list, the pen labels and the needles, has no counterpart in a tablet.
On September 29, 2026, the Justice Department announced that a federal grand jury in the Middle District of Florida had charged two Indian nationals, Swapnadip Roy, 33, and Vicky Ramancha, 37, over a transnational counterfeit Ozempic scheme. Roy was extradited from Italy and made his initial appearance in Tampa.
The charges are one count of conspiracy to commit smuggling and to defraud the United States, three counts of smuggling, and two counts of selling counterfeit drugs and holding counterfeit drugs for sale. Each faces a maximum of 71 years. The alleged conduct ran from at least July 2023 through April 2024, and the product was sold to distributors in the United States at deeply discounted prices.
The part worth reading closely is the inventory. According to the Justice Department’s release, the defendants allegedly obtained counterfeit Ozempic from unauthorized sources in China, and the products allegedly included counterfeit packaging, package inserts, pen labels, and needles, intended to make buyers believe the product was authentic.
Four separate counterfeit components, plus a pen-shaped object, plus a drug substance of unknown origin. That is the cost sheet for faking an injectable, and somebody paid it. The FDA seized some of the product in December 2023 and issued a public warning. The release states the scheme continued after that.
Justin Green, Assistant Commissioner of the FDA’s Office of Criminal Investigations, which ran the investigation, put it this way: “Drug safety and quality do not begin or end at the U.S. border.”
The barriers in that list are about to disappear
On June 11, 2026, the Medicines and Healthcare products Regulatory Agency approved semaglutide tablets, branded Wegovy, as the United Kingdom’s first GLP-1 receptor agonist tablet for weight loss and weight management. The authorisation went to Novo Nordisk. Treatment starts at 1.5 mg once daily and steps up through 4 mg, 9 mg and 25 mg, with at least a month at each level, for adults with a BMI of 30 or above, or 27 to 30 with a weight-related comorbidity. Julian Beach, MHRA Executive Director of Healthcare Quality and Access, noted that “as with all GLP-1 receptor agonists, this is a prescription-only medication.”
Now read the Roy and Ramancha indictment against that product.
No pen. No pen label. No needle. No package insert describing an injection technique. No cold chain. No injection-moulded dose dial, no spring, no cartridge. What remains to be counterfeited is a tablet, a blister, a carton and a leaflet.
Writing on Intelligent Health.tech on October 21, Rebecca Miles set out the same concern, drawing on Heather Clarke-Hite, Director of Crane Authentication. The argument is that injectable pens involve complex delivery mechanisms, cold-chain requirements and greater manufacturing precision, while “counterfeit tablets are typically easier for bad actors to manufacture and package,” can move through postal and courier services, and allow a single batch to be split into many small parcels, which complicates detection. The piece also notes that “appearance alone is becoming an unreliable indicator of authenticity.”
Two things to say about that source before going further. Clarke-Hite is a director of an authentication company, so this is an interested party describing a market it sells into, and the piece should be read as informed commentary rather than neutral analysis. It also carries a figure, that 97 percent of pharmacies are worried oral pills could increase fake or unlicensed medicines, for which no survey is identified, so we are not relying on it.
The underlying mechanical point does not depend on who is making it. It is simply true that a tablet has fewer parts than an injector pen.
The hard part was never verification
Here is the uncomfortable thing about the injectable era, and it is worth being blunt.
For years, the practical obstacle to counterfeiting a GLP-1 was manufacturing difficulty. A pen is an engineered device. Reproducing one convincingly, with a plausible dose mechanism and a needle and a cold chain behind it, cost real money and real skill.
That was never a verification method. Nobody at a pharmacy counter authenticated a pen by assessing the tolerances of its dose dial. No regulator required a device-integrity check at dispense. The industry simply enjoyed the incidental protection of a high manufacturing barrier, and treated the printed carton as the thing to look at.
The Roy and Ramancha case shows what that incidental protection was worth even at its strongest. The barrier held for a while and then somebody cleared it: according to the Justice Department, the defendants obtained counterfeit Ozempic, complete with counterfeit packaging, inserts, pen labels and needles, from unauthorized sources in China, and sold it to American distributors from at least July 2023 through April 2024, including about four months after a public FDA warning.
With the tablet, the barrier is gone and nothing has moved into its place. At most dispensing counters the checks available in October 2026 are still the ones available in 2023: look at the carton, read the batch number, trust the supplier and, where serialization rules apply, scan the pack’s code against a database. None of them tests what is in the pack.
The categories without any barrier never had this debate
It is also worth remembering that most counterfeit medicine has nothing to do with weight loss, and has never involved a device.
On October 21, Pakistan’s Drug Regulatory Authority issued alerts over five batches of counterfeit medicines detected in Karachi. The products were Augmentin tablets, Velosef capsules, Nasomet nasal spray, No-Spa Forte 80 mg tablets and Mucaine syrup. The Drug Testing Laboratory in Karachi declared samples from all five batches counterfeit. DRAP said the raw materials could not be verified, so the quality, safety and effectiveness of the products are unknown, and that they had been illegally manufactured and sold under the brand names of national and multinational pharmaceutical companies. Provincial drug control authorities and field teams were directed to seize the affected batches, and DRAP warned that use could be life threatening.
Two antibiotics, one of them a cephalosporin, a steroid nasal spray, an antispasmodic and an antacid. Cheap, ordinary, everywhere. No device, no cold chain, no high manufacturing barrier, and they have been counterfeited for years precisely because there was never anything in the way.
That is the honest frame for the oral GLP-1 question. A weight-loss tablet is not entering a protected category. It is leaving one, and joining the category that everything else was already in.
What a tablet actually offers an inspector
Set out what is checkable on an oral solid dose and the problem is quickly obvious.
The carton, which is printed, and which the MHRA’s Birmingham warehouse raid on October 14 showed is being stockpiled: alongside more than 12,000 counterfeit injector pens, officers found packaging for around 30,000 more products. The blister foil, also printed. The leaflet, printed. The batch number and expiry, printed. The tablet’s own appearance, which is a shape, a colour and a debossed marking, all of which a tooling shop can reproduce.
And then the one thing a printed surface cannot vouch for, the chemistry, which requires a laboratory. DRAP’s five batches were declared counterfeit by the Drug Testing Laboratory in Karachi.
The pen at least had a physical artefact with internal complexity. A tablet gives an inspector a printed surface and a shape.
The objections, briefly
Prescription-only status is the control. It is a real control, and the MHRA has been explicit about it. It governs who may supply the medicine, not what is in the box that arrives at the pharmacy. The Roy and Ramancha product allegedly went to US distributors, which is upstream of any prescription.
Oral semaglutide is harder to synthesise than a small molecule. Fair, and a serious point. A counterfeiter does not have to synthesise it. The DRAP batches were not failed syntheses, they were products whose raw materials could not be verified at all, and the counterfeit Ozempic in the FDA’s own earlier alerts contained unknown contents in genuine-looking packaging.
Serialization already covers prescription packs. It covers packs in the regulated chain, by checking a number against a database, which is a different question from what is inside the pack. We wrote about the limits of that last week and they have not changed.
This is a vendor talking up a market. Partly, and we have said so. The mechanical claim stands on its own: an oral tablet has fewer counterfeit-resistant components than an injector pen, and nobody disputes that.
Oral formulations improve access, which is a public good. Yes, unambiguously. A tablet reaches people a cold-chain injectable does not, and that is a benefit worth having. The point is not to regret the tablet. It is that the protection the injectable provided by accident now needs to be provided on purpose.
What each party should be able to prove
For a manufacturer launching an oral GLP-1, the test is what distinguishes your tablet from a visually identical one when the carton is no longer evidence. The device used to be part of your answer. Work out what the answer is now, before the first counterfeit shows up rather than after.
For a regulator, the test is whether anything in the dispensing workflow changes between an injectable and a tablet. If the answer is nothing, then the risk profile has changed and the controls have not.
For a pharmacist, the test is what you would do with a pack that looks right. In the DRAP cases, five batches reached the market and were declared counterfeit by a laboratory. That is the current state of the art for an oral solid dose.
For a prescriber, the test is whether a treatment failure would be investigated as a possible counterfeit. Falsified medicine presents as a drug that did not work, and the default explanation for a weight-loss drug that did not work is the patient.
For a patient, there is no test, which is why regulators keep giving the same advice: the FDA tells patients to obtain Ozempic only with a valid prescription through state-licensed pharmacies, and the MHRA stresses that the tablet is prescription-only.
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