The black market for covid-19 antiviral drugs
BMJ 2022; 377 doi: https://doi.org/10.1136/bmj.o1282 (Published 31 May 2022) Cite this as: BMJ 2022;377:o1282
Recently, reporters from The BMJ posted a request on the online market website Indiamart. They wanted to buy a hundred boxes of generic molnupiravir (Lagevrio), Merck’s oral antiviral drug, given to people infected with covid-19 to prevent severe disease, and have them sent to Mexico. Within hours, three sellers got in touch to make offers, even though the Mexican authorities have not permitted generic versions of the drug to be imported into the country.
One seller gave advice on how avoid customs. “The customs in Mexico are crazy and the clearance process is not so easy,” wrote an account named Rakshit Jain from Bull Pharmachem. “Most of our Mexican customers prefer to have it shipped to the USA and then they carry it across. We regularly do this for a lot of Mexican clients,” he wrote, advising us to ship 10 boxes at a time. “Each country has their own set of rules for importation and none is easier than the USA. We ship to Chile, Peru, Colombia, and Brazil every day,” he added.
A worldwide black market for molnupiravir has developed, despite the drug’s lacklustre results in trials. Although experts now question whether molnupiravir’s approval was premature1 and some doctors eschew its use,2 patients are paying high prices for generic versions online. These drugs are then taken without medical supervision and may not be safe.
The safety of molnupiravir and Pfizer’s antiviral nirmatrelvir (Paxlovid) have not, for example, been established in pregnancy. In the US, the Food and Drug Authority recommends that patients do not have unprotected sex for at least three months after taking molnupiravir. In the UK, women of childbearing age are told to use contraception while taking the drug and for four days afterwards.3
“If molnupiravir is sold through the black market and used without medical supervision, there is a risk that patients will not understand these problems and take the drug without proper contraception,” says Andrew Hill, a senior visiting research fellow in the pharmacology department at Liverpool University. “This could then increase the risk of birth defects.”
There is no guarantee that black market drugs have gone through adequate quality control, says Paul Little, professor of primary care research at the University of Southampton. Widespread, unregulated use of antivirals may also encourage viral resistance, he added. He called for “high level public campaigning” about the dangers of taking black market antivirals.
Disappointing results
Developed by Merck and Ridgeback Biotherapeutics, molnupiravir was the first oral antiviral brought to market and was sold to more than 30 countries.4 In interim results announced in a press release in October 2021, Merck said the drug reduced risk of hospital admission or death by around 50% in people with mild to moderate covid-19,5 while a separate trial found nirmatrelvir showed a reduction of nearly 90%.6
When Merck’s final study was published it showed only a 30% reduction in risk.7 Further trials found molnupiravir “did not demonstrate clinical benefit”8 or showed a reduction only in hospital admissions in people over 60 years old.9 Researchers like Hill are calling for the UK Medicines and Healthcare Regulatory Authority (MHRA) to reconsider molnupiravir’s approval once the results of Oxford University’s UK-wide Panoramic trial have been released. Panoramic included molnupiravir in its platform trial and represents the first independent study of the drug. “It is possible that no significant improvement in hospital admission risk will be seen in Panoramic,” Hill says.
But it may be too late. The company’s interim data created a buzz around the drug which sparked demand among people in many countries.10 In November 2021, UK health secretary Sajid Javid called it a “gamechanger”11 after stockpiling 480 000 doses of the drug before it was authorised by the MHRA.12 In many countries, demand was met by black markets.
Unauthorised generics
In the UK, the MHRA said molnupiravir should be prescribed only by a doctor or as part of a clinical trial. But The BMJ found a website, buymolnupiravironline.com, apparently based in London, selling a course of the drug for £124.99, seemingly without prescription or review by a doctor. The BMJ contacted the MHRA about the website and a spokesperson said, “Websites that offer to supply prescription only medicines without a prescription are not only in breach of UK legal requirements and likely to be committing a criminal offence but are putting patients’ health in jeopardy.” Buymolnupiravironline.com did not respond to The BMJ’s request for comment.
In Mexico, molnupiravir was given emergency approval on 7 January 2022,13 as the country saw the most rapid increase of covid-19 cases since the onset of the pandemic.14 The news prompted an all time high in Google searches for the drug and ways to buy it.15 Under the emergency declaration, it would be available only at federal and state hospitals and no generic versions were authorised for importation.
Just a week later, on 14 January, COFEPRIS, the regulatory body in charge of the drug approval process, released an alert to warn the public of the illegal sale of two unauthorised generics of molnupiravir.16 Those generic unauthorised drugs—produced by Azista and Merit Organics—continue to be distributed online in Mexico, selling for around MXN$14 000 (£562; €656; $703) for a pack of 40 tablets.
Other versions of molnupiravir were offered for sale as early as 19 July 2021 on Facebook,17 more than three months before the first authorisation for the drug was granted in the UK18 or any results of the stage 3 trials had been released.
For consumers it is hard to distinguish between authorised and unauthorised generics. To accelerate and expand global access to molnupiravir, Merck authorised the production of generics under a voluntary license. This was initially to five Indian companies19 and later to the Medicines Patent Pool (MPP), the UN backed organisation working to increase access to drugs in low and middle income countries through negotiating licenses and shared intellectual property, which further extended it to another 27 companies.20 Azista and Merit are not among those companies, and it is unlikely they have been tested for bioequivalence, says Andrea Taylor, assistant director of programmes at Duke University.
If the drugs have not been tested for bioequivalence they may be substandard, which means less of the drug gets into the bloodstream and there is a risk of reduced efficacy, says Paul Newton, head of the Medicine Quality Research Group at the Infectious Disease Data Observatory. The BMJ contacted Azista and Merit Organics with these allegations but did not receive a response.
Inequality in access
The Mexican government was not the only one warning the public against unauthorised covid-19 antivirals. In January 2022 the government of the Philippines warned about the spread of illicit molnupiravir in the country,21 advising the public not to buy drugs from unauthorised sources. Articles online describe how people are using unauthorised molnupiravir in Japan22 and Vietnam.23
“Inequality is a driving force in the distribution of substandard and falsified medical products,” says Pernette Bourdillon-Esteve, the World Health Organization’s acting team lead for incidents and substandard and falsified medical products. “When people cannot access safe quality medical products, they might turn to unsafe sources.”
According to data from Duke University, most of the supply of molnupiravir has been purchased by high income countries, a trend that is predicted to continue in 2022. As of 4 April 2022, nearly 66% of all molnupiravir has been bought by high income countries.24 Merck said it has strategies in place to accelerate global access, including granting voluntary licenses to the MPP to allow generic versions to be produced for low and middle income countries, and an agreement with Unicef to distribute doses.
Social media marketplaces are one of the ways substandard and falsified medical products are distributed, says Bourdillon-Esteve. “People often have the image of a dodgy pharmacy—and that certainly is the case—but there are other online mechanisms, whether it is Facebook or Instagram, among many others.”
In Mexico, since molnupiravir is available only in certain federal and state hospitals, doctors working in private institutions said patients had bought unauthorised generic versions online. Benjamin Valente Acosta, a specialist in internal medicine at the ABC Medical Center, a private hospital in Mexico City, said some of his patients paid MXN$15 000-30 000 for a five day course.
For black market sellers, obtaining the drugs wholesale requires little effort. On websites such as Indiamart, an online marketplace which has connected 550 million sellers and buyers in the past year, anyone can request to buy molnupiravir and dozens of sellers reach out with generics available to be sent to virtually any country. Among the generics on offer were the two produced by Azista and Merit that the Mexican government warned against. Indiamart told The BMJ that it is “a content platform with huge data aggregation and processing happening every second” and therefore “it is difficult to monitor content.”
It said it works with an array of national and international organisations monitoring counterfeit and substandard drugs and regulatory malpractices. These include the International Narcotics Control Bureau, India’s Narcotics Control Bureau, and React, a global anti-counterfeiting network.
An Indiamart spokesperson said that users of the website sign up to terms of use in which they agree not to violate any law, statute, ordinance, or regulation. “Our endeavour is to create a marketplace ecosystem for legitimate and lawful products,” he added.
The profit margins for black marketeers are large. The generics sold by Bull Pharmachem costs $35 a box, plus $50 for the shipment of 10 boxes. In Mexico, vendors can sell them for at least 18 times that price.
In a statement Bull Pharmachem told The BMJ that it “categorically denies” its employee offered to ship molnupiravir to Mexico and other countries or gave advice on avoiding customs, and said an impostor was speaking under its company name. It added, “We have not exported a single bottle of molnupiravir to the US or Mexico, ever.”
However, The BMJ believes our reporters were speaking to a genuine member of the company. The Bull Pharmachem shop on Indiamart had a TrustSeal verification—where Indimart has verified that a company is genuine. Companies pay around $300 a year for verification, which involves physical verification and Indiamart confirming uniquely identifiable information on the company, such as its tax identification and export license. That same verification is proudly displayed on Bull Pharmachem’s official website. The Bull Pharmachem Indiamart vendor gave out contact details matching those of the official company, rather than a fake phone number or email address, and gave another mobile phone number as a back up which matches that of Bull Pharmachem’s chief executive, Parag Jain.
The BMJ also asked Indiamart if it had received any complaints about the Bull Pharmachem vendor registered on Indiamart, which has been active for seven years. Indiamart said it had not received any complaints from sellers or from Bull Pharmachem itself.
“Every region in the world is affected by the problem of substandard and falsified medical products. Because of constraint, access, poor governance, and weak technical capacity, however, some regions will be more vulnerable,” says Bourdillon-Esteve.
“Patients taking molnupiravir, generic or patent, must have medical supervision. These drugs should not be accessible for everyone to buy without it,” Valente added.
Footnotes
This feature has been funded by the BMJ Investigations Unit. For details see www.bmj.com/investigations
Commissioning and peer review: Commissioned, externally peer reviewed.
Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.
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