Drug Supply Chain Security Act (DSCSA), going into effect in November 2023, the FDA will require companies across the medical and pharmaceutical industry to eliminate fakes and increase the safe use and identification of drugs.
What do collectible sports cards and the medicine in your cabinet have in common? There’s a chance they are fake or not worth the price tag attached to them—at least that’s the reality as industries grapple with the estimated $2.3 trillion counterfeit market.
In relatively benign cases, counterfeits can lead to financial loss. In worst-case scenarios, they can cause health or safety concerns and even death, when parts, pharmaceuticals or goods are illegitimate and misidentified.
Why Additive Measures Aren’t Enough
The problem of authenticating goods traditionally required additives that call for manufacturing overhauls, such as QR codes, hologram stickers, barcodes or radio-frequency identification and near-field communication tags, serving as a Band-Aid for deeper issues. Having led hardware and software companies, including a machine vision solutions provider, I believe every industry—from aerospace and defense, to precious metals and pharmaceuticals, to automotive and collectibles—needs a source of irrefutable truth to ensure items bought and used by employees and consumers are legitimate, safe and correct.
One thing is for sure: Companies can no longer rely on additives to help solve these issues no more than people can truly rely on a “smart” badge for identification. If you have ever lost your badge, perhaps allowed someone else to use it or had its RFID spoofed, you know they are not reliable as a means of identification.
The path toward a future without fakes and with reliable product identification will need to rely on advanced technology using the items themselves as their own identifier. Think what fingerprints are for humans.
High Stakes In Healthcare
Pharmaceuticals and medical devices are seeing an unprecedented and insidious rise in counterfeit drugs and packaging. The explosive growth of internet pharmacies and generic drugs increases access and reduced costs for many medicines. Unfortunately, these same forces increase the risk of counterfeits, poorly formulated pills or even ones laced with substances such as fentanyl, endangering patients’ lives.
Now with its looming Drug Supply Chain Security Act, going into effect in November 2023, the FDA will require companies across the medical and pharmaceutical industry to eliminate fakes and increase the safe use and identification of drugs. The drive to lower medical costs can lead to the tempting purchase of cheaper medical equipment from less secure sources, resulting in frightening cases such as counterfeit and expired surgical devices or counterfeit HIV drugs, putting patients at risk of serious infections or worse.
Pharma and medical device manufacturers must proactively safeguard their products in a clear and irrefutable way, to protect the lives of their patients. Clear traceability from the production line all the way to the patient must be achieved.
Collectibles And The Third-Party Challenge
Collectibles is another industry rife with bad actors taking advantage of multimillion-dollar price tags for record-setting home run baseballs, decades-old baseball cards or the rare coin. Unfortunately in this space, no governing body exists to regulate fraudulent sales or prevent somebody from replicating a card, getting it certified by a grading company and selling it at an auction. They could even buy an authentic item then “return” it with a counterfeit or lower-grade substitute.
Moreover, with e-commerce becoming easier and more accessible than ever, illegal dealers often push fraudulent items onto collectors directly via third-party platforms. Moving forward, third-party platforms, whether online or physical auction houses and dealers, must perform due diligence and verify that items are what they claim to be. The “neutral third party” or “I am just the marketplace” excuses are no longer acceptable.
Mapping Out Your Strategy
When integrating next-gen technologies to fight counterfeits or track and trace items, map out your needs. First, identify the last point in your value chain where you can be confident the item at hand is in fact what you think it is—whether the beginning or end of your production line, your distribution center or elsewhere. There is no right or wrong answer, but this uncovers potential areas worthy of improvement.
Next, identify potential risk areas between that last point and your end consumer. It might be loading docks, warehouses or retailers—locations that need irrefutable identification capabilities to help you know if your real, legal and correct item made it through or not. If all goes well, you will have a clear trace of your products. If at any point something raises a red flag, you will immediately know in what section of your chain the issue occurred.
For equipment, consider who will be doing the checks and the environment in which they will be done. Will it be one of your employees you can train or a random person assigned to the task that needs to be able to quickly learn the process? Will they be doing this in a controlled warehouse with well-positioned stations, or will this be done “on the move,” requiring something more mobile? Understanding this ahead of time will make planning much easier.
Finally, if you already use additives on your products or packaging, you can easily leave them in place. In fact, you could authenticate that the additives are real and yours. While redundant, this adds yet another layer of security. Alternatively, you can stop using additives altogether, reducing your costs, environmental impact, design impact and more. After all, if I can enter the building with my fingerprint, do I really need to carry around a badge, too?
Epilogue
In recent years, it has become ever more evident that bad actors abound, are ever more brazen and use the most sophisticated tools. Globally, and across widely different industries, the common denominator is that so many products are susceptible to counterfeits, gray market and illegal activity with potentially severe consequences.
To get in front of the plethora of counterfeits circulating the globe, companies need to adapt and apply the next generation of technologies, which not only uniquely identifies any individual item, but also helps manage the vast amounts of data and points of differentiation that it takes to authenticate, track and trace products.
Tags: Counterfeit DSCSA New Drug Trends New Technology New Trends Safety
