Known for its ghats and its temples, the Indian city of Varanasi is renowned as the spiritual centre of Hinduism, a place where cosmic battles reverberate in stone. But in 2019, this town by the Ganges bore witness to a far earthier struggle. That March, police raided a local wholesale market, where they discovered thousands of counterfeit medical devices. Alongside a second swoop in Delhi, a senior officer described the haul of fake surgical products as “one the biggest raids to bust counterfeit products in recent times”.
Yet even as the Varanasi criminals were being led away to trial, plenty of others were waiting to take their place. The numbers here are clear enough, with 2010 research from the WHO finding that a full 8% of medical devices in circulation were known to be fake. Nor has the problem really been solved over the subsequent decade and a half. In 2022, to give one example, staff from the UK’s Medicines and Healthcare Regulatory Agency (MHRA) seized some 285,000 counterfeit drugs medicines from addresses across the country.
And if that last operation seized goods worth some £850,000, it goes without saying that the consequences of counterfeit devices are much more than financial. “The consequences of counterfeit devices pose a significant safety risk to patients including the potential to cause injury, disability or even death,” explains Dr Mark Deakes, chairman at the International Hologram Manufacturers Association (IHMA). “In addition, there is the loss of confidence in the medical device brand due to its failure to help reduce or alleviate symptoms.”
Yet if Deakes lays out the scale of the problem, might he and people like him equally hold the solution? Certainly, sophisticated holograms have the potential to upend the fight against device counterfeiting – especially when integrated with other interactive features like serialisation for track and trace, they make forgery far harder. That’s before you consider the host of brand engagement and regulatory advantages holograms offer too. Not that the fraudsters must simply be defeated once, with honest insiders instead obliged to constantly update their defences as the criminals innovate in turn.
Keeping it real
As that £850,000 MHRA raid implies, counterfeit medical devices involve big money. Perhaps ironically, this bonanza is largely animated by the parallel rise of legitimate devices. Think about it like this: with Statista reporting that the global medical devices market is currently worth $510bn, a figure expected to reach almost $675bn by 2029, there’s obviously increasing room for criminals to make bank too. That’s reflected, Deakes continues, by the medical vagaries of recent years. Consider the pandemic. In May 2020, the British government announced the manufacture of 70 million face masks, each destined for put-upon health workers. With production targets like that floating about, and with politicians rushing to secure equipment at speed, it’s easy to see how fakes could slip into the supply chain.
Once you factor in the rampant popularity of new weight-loss drugs – in June 2024, the WHO warned of fake Ozempic pen devices in Britain and Brazil – and no wonder Deakes says that the proliferation of counterfeit devices has “continued unabated” even as Covid-19 has waned.
No less important, of course, are the practical consequences of these crimes. That clearly starts with health, with countless depressing examples to choose from. In Israel, for instance, fake versions of drugs used to treat diabetes left many with psychiatric conditions, after it transpired that the medicine contained high traces of MDMA. In the US, meanwhile, an influx of counterfeit KN95 masks from China left wearers vulnerable to airborne diseases like coronavirus. That’s echoed, Deakes adds, by reputation damage.
“For legitimate manufacturers,” he says, “there is the loss in revenue from the impact of counterfeits, erosion of brand reputation, reduced funds available for research and development, potential legal implications, and increased costs due to the inclusion of product security authentication measures.”
Given these varied challenges, at any rate, it makes sense that OEMs should have invested so heavily in making their devices counterfeit-proof, with holograms an important tactic. Virtual threedimensional images, they’re much harder to mimic than regular signs – obviously beneficial to anticounterfeit teams. Not that every hologram is identical; on the contrary, Deakes describes how companies have developed a range of manufacturing options since Glaxo first used a tamper-evident hologram back in 1988. Encompassing labels, seals and hot-stamped patches, the form holograms take depends on the device it’s protecting.
8%
The percentage of medical devices worldwide estimated to be fake in 2010.
Medical Device Network
Yet if blister-foil packs unsurprisingly need different holograms from glass bottles, there can be no doubt about their efficacy. To explain what he means, Deakes offers the example of Biotehnos and Rompharm. A pair of Romanian companies, they noticed that sales of their (anti-inflammatory) Alflutop and (cartilage regeneration) Rumalon products were slumping in Russia. The problem, they soon realised, was because the brands were being targeted by counterfeiters, with doctors reluctant to prescribe dodgy drugs. To get around the problem, the Romanian pair deployed holographic labels to their ampoules – stopping the criminals in their tracks and restoring the confidence of medical professionals. That dovetails with other successes too, notably in Malaysia, the first country to integrate holograms right across pharmaceuticals.
All that glitters
Whatever the strengths of holograms until now, criminals are nothing if not resourceful. To put it differently, for every defensive hologram that enters the market, crooks will be there to counter it. With that in mind, at any rate, it makes sense that Deakes should stress the “constantly innovating and evolving” nature of medical device holograms. In practice, there are a near endless list of case studies to choose from here, from new substrates to better coatings. Improved manufacturing methods, allowing for the development of intricate metallised patterns and coloured effects, is pushing the sector forward too, even as Deakes talks of tamper evidence effects and dual-sided features.
$250bn
The estimated size of the global anti-counterfeiting packaging market by 2026.
The Packaging Portal
Yet arguably the most striking development in this $6bn industry is the way OEMs are integrating digitalisation into their holograms. As Deakes puts it: “New digital origination processes and design software are capable of producing new ever more sophisticated security features and effects: overt, covert and forensic.” Undoubtedly, it’s a point amply supported by real-world examples. In India, the site of so many counterfeiting fights, there’s the example of Holostik. Based in New Delhi, this leading authentication provider has developed QR codes that can be integrated into holograms, preventing replication and keeping criminals at bay – and offering a plethora of supply chain management opportunities.
As Deakes says, that’s reflected elsewhere too, noting how “trademark and intellectual property protection, product quality control, online management, cybersecurity and domain protection, supply chain security, legal action and consumer education” can all be bolstered by robust hologram technology. “Holograms are eye-catching and unique,” Deakes continues. “Incorporating them into product packaging or labels can elevate a brand’s image.” It’s a fair point if you head out into the marketplace, with Pfizer and J&J just two of the sector giants to feature attractive holograms on their products. The statistics, for their part, point in a similar direction. As one recent study revealed, the global market for anti-counterfeiting packaging is set to reach almost $250bn by 2026.
Cat and mouse games
What might the future hold for medical device holograms? Once again, the answer to this question partly lies in what the criminals conjure up. With bad actors constantly eager to outwit their opponents, hologram insiders must be agile enough to react in kind. A case in point is the Security Image Register (SIR). Developed by the IHMA, this is the only system of its kind for the authentication community. Offering a global hologram database, the SIR allows technology manufacturers and producers to verify that new examples don’t infringe copyright law, along the way allowing law enforcement officials to verify if suspect holograms are indeed fakes.
That’s shadowed, Deakes adds, by the continued rise of digitalisation. Digital interactivity with smartphone devices, he says, is one good example here. So-called ‘near-field communication’ is another, with holograms being able to contact trackers or scanners via short-range wireless technology. As Deakes summarises: “Holograms will become more integrated with digital technologies, creating intuitive authentication and brand engagement programmes.” Regulation, for its part, is rushing ahead too. Where Malaysia has led, other jurisdictions are now following, with the EU recently unveiling a Falsified Medicines Directive obliging manufacturers to integrate digital mass serialisation and tamper-evident systems into their designs. Given the continued threat of fakes, whether in Varanasi or a million other places, such caution seems wise.
