Forged drug batch numbers, which are being used by criminals to sell dangerous lookalike weight loss products, could be linked to a massive global counterfeiting operation preying on unsuspecting gullible consumers, warn police and international agencies.
Pharmaceutical companies, including Ozempic-maker Novo Nordisk, authenticate batches of drugs with combinations of letters and numbers printed on the packaging, which are then used to track the product in a given country.
Fake pens recently found in Mexico were carrying the batch or lot number MP5B060 to make them look authentic, representing a shipment of the diabetes drugs destined for Egypt.
The numbers are meant to ensure the drugs are traceable and safe, but imitations, carrying the same numbers are landing up in completely different countries, partly due to patchy regulation by health authorities globally.
By the time the Mexican batch was uncovered, fakes with the same lot number – MP5B060 – had turned up in at least 10 countries, from Azerbaijan to North Macedonia, according to a Reuters review of drug regulator announcements and documents obtained through Freedom of Information Act requests.
The World Health Organisation (WHO) issued a warning in July 2023 about products with batch number MP5B060, and Interpol also warned last year that insulin pens were being relabelled and repackaged to look like Ozempic.
Some countries banned products with the number. Others did not.
Mexico’s drug regulator did not respond to a request for comment.
In at least four countries, the fakes have resulted in hospitalisations. In the US, Nigeria and Iraq, the fake Ozempic shots looked like insulin pens, according to Reuters’ review of the documents and regulator announcements. In Iraq, a man fell into a coma after his blood sugar dropped to half normal levels after using one, before later recovering.
Multi-billion-dollar market
Criminals can get hold of batch numbers through a corrupt connection at a drugmaker’s manufacturing facility, or just by buying the drug and using scanning technology to copy the packaging, inserts and so on, said Sam Louis, a former US Department of Justice lawyer focused on healthcare fraud matters.
With at least 890m people suffering from obesity globally, according to the WHO, demand is huge. The active ingredient in Ozempic – semaglutide – leads to an average weight loss of 15%.
Novo Nordisk is working with authorities in several countries to tackle counterfeits of both Ozempic and Wegovy.
Novo’s head of global product security, Anne Devaud, told Reuters the company potentially has identified one source in connection with the batch number on the counterfeit in Mexico, which it also suspects of distributing fake versions of other companies’ injectable drugs.
The wide recurrence of the same batch number suggests a global counterfeiting operation could be to blame, five anti-counterfeiting experts and a WHO official said.
“Our experience is that when you have the same batches and labelling, it is most likely the same people or maybe several smaller distributors that have purchased from one big source,” said Rutendo Kuwana, the WHO team lead for incidents with substandard and falsified medicines.
Bootlegged batch numbers and repackaged insulin are just part of the picture: criminals can divert or steal drugs from hospitals or other healthcare systems before adding fake labels and packaging, or they can simply put any liquid in a vial or stamp out pills and place them in counterfeit packaging, a Novo spokesperson said.
“All these different potential origins, often via organised criminal networks involving multiple jurisdictions, represent serious challenges for those involved in fighting these crimes,” the spokesperson said.
Even so, at least 18 different batch numbers have been found on fake Ozempic pens in 14 countries since the start of last year, adverse event reports and health regulator announcements show.
The solution is not simple. A legitimate Ozempic batch contains 280 000 pens; some countries ban all products carrying a batch number after finding fakes that carry it. Others do not, saying that to withdraw a whole batch just because of a few fakes could exacerbate shortages.
Jared Davis, a former US Food and Drug Administration and Homeland Security agent, who is now a consultant on counterfeiting issues at law firm Oberheiden, said it was difficult for government agencies to stop the spread of fakes when demand is so high.
“Most countries aren’t going to pull the entire line and get rid of it because an organisation or a few folk decided they’re going to run a counterfeit scheme and target that particular batch number,” he said.
Deadly resemblance
Fake Ozempic adds to a glut of counterfeit pharmaceuticals that kill around 1m people each year. A September 2023 report from the US CDC said use of suspected fake pills, including painkiller Oxycontin, led to nearly 55 000 deaths in America in 2021.
Overall, Ozempic faked in a variety of ways has been found in nearly 30 countries, Reuters found. Fakes have been linked to more than two dozen cases of serious harm globally, and to two deaths in the United States.
Ozempic can cost more than $1 000 in the US for a multi-dose pen that lasts a month, but in the Mexican border town of Nuevo Progreso, for instance, it can be bought for between $200 and $350 a pen.
Rebadging insulin to look like Ozempic is lucrative. Like some types of insulin, Ozempic comes in a blue, prepackaged auto-injector.
Insulin can be bought for as little as $8.81 per unit outside the US, according to a report from the RAND Corporation on the global cost of the drug.
An insulin product manufactured by French drugmaker Sanofi, branded Apidra Solostar, comes in a prepackaged blue auto-injector with a clipped lid similar to Ozempic.
A Sanofi spokesperson said the company was aware of illegally mislabelled Apidra pens being passed off as Ozempic, and has been working with partners to protect patients, but declined to comment on whether the company has since tried to distinguish its product from Novo’s.
Novo, asked if it would make Ozempic pens more distinctive, said it was unlikely that any one change would prevent fakes because counterfeiters can adjust nimbly.
To ban or not to ban
Azerbaijan first flagged it had found fakes using batch number MP5B060 in December 2022.
The WHO’s warning came after three more people suffered severe low blood sugar, or hypoglycaemia, after using fake Ozempic pens with the same Egyptian batch number: a woman in Britain who got her auto-injector at a beauty salon, a man in Serbia who bought his in the United Arab Emirates, and a woman in Lebanon, according to separate reports sent by Novo Nordisk to the FDA that were reviewed by Reuters.
In America, a woman suffered severe hypoglycaemia and was admitted to the emergency ward after taking what she thought was Ozempic with that batch number, a US report shows. The report said her outcome was not known.
Some countries, including Poland and Ukraine, said they have banned the importation and sale of drugs marked with bootlegged batch numbers identified by international agencies. But regulators in Britain, Finland, Ireland and Sweden told Reuters they had not.
Ireland’s health ministry said it found no fakes under batch numbers flagged by the European Union, so simply alerted wholesalers and others to be vigilant when buying Ozempic. It said it had other controls in place to block falsified packs, including scanning barcodes printed on them.
Britain’s health regulator said in response to a Freedom of Information Act request in May that it had opted to focus on visual differences between the pens, such as differences in colour and construction, rather than banning batch numbers. Asked why, it said in July that banning batch numbers risked causing shortages of legitimate medicines.
Britain and Ireland’s regulators did not comment on the possibility that not banning batch numbers might help them circulate.
Massive profits
Reported counterfeits of Ozempic have been more common than those of Eli Lilly’s Mounjaro, a newer rival. But these too are on the rise.
An FDA report seen by Reuters said a 61-year-old woman in the US had been hospitalised for severe stomach pain and seizure after vomiting 70 times over four hours last January, having taken a fake version of Mounjaro sold to her in a vial by a health consultant, who was not named. As of early May, she had partly recovered, the report said.
Lilly said the proliferation of counterfeit and unsafe or untested versions of its drug is a significant safety concern; steps it has taken include a tool to help people determine if they have a genuine Lilly product.
But it called on the authorities to take more action against those who circulate knockoffs.
Sophisticated global counterfeiting operations can make massive profits from such fakes and often find ways to evade detection, said Rana Saoud, a special agent in charge at US Homeland Security Investigations. The National Institutes of Health, the government agency responsible for public health research, has said the counterfeit drug trade as a whole could be worth as much as $431bn annually, citing analysts.
Identifying leaders of such a supply chain is a challenge. In May, a New York woman, Isis Navarro Reyes, was charged with smuggling fake versions of Ozempic and other weight loss drugs into the US, then using TikTok to help sell the products. She could not be reached for comment.
“Until we get specifics…we’re not going to know if it’s a lone actor or part of a criminal organisation,” said Saoud at Homeland Security Investigations. “But generally speaking, it’s an organisation looking to profit.”
See more from MedicalBrief archives:
SAHPRA issues warning about fake Ozempic
Fake Ozempic sends users to hospitals
WHO warning on fake diabetes, weight loss drugs
Hundreds of websites flog fake weight-loss and other drugs