U-NICA Apr 19, 2021 1:20:34 PM 10 min read


A closer look at the measures the pharmaceutical industry has in place to hunt down counterfeit pills and tablets and why more help is needed

If I had to give you a short answer to my blog title today, it would be “no.” But it’s not from lack of trying. While it’s comforting to know that multiple pharmaceutical anti-counterfeiting measures exist, they face a never-ending battle against fake medicines and a flood of potentially deadly black-market tablets and pills.

Why is medication such an attractive target for them? Pharmaceutical drugs check two boxes these criminals love to see: An appearance that is easy to simulate and a product that commands high market value.

Counterfeiters are often highly skilled but unscrupulous craftsmen, so it couldn’t be easier for them to emulate the look of a tablet or pill and fill it with any toxic substance you can name. From there, it’s another easy task for them to distribute the fakes in convincing packaging.

The EU is losing €16.5 billion to counterfeit drugs. Worldwide, the value of this market has leapt from $30 billion in 2017 to $200 billion in 2019.

But pharmaceutical anti-counterfeiting strategists are fighting back. Let’s spotlight some of the organizations that make pills and tablets as safe as possible and identify counterfeit drugs by tackling the biggest vulnerabilities they face.

Interpol and monitoring the worldwide web

Interpol’s Operation Pangea has evolved impressively to keep pace with the creators of black-market medicines. Founded in 2008, this watchdog has grown from supervising 8 countries to 123. Its focus is on arguably the biggest weakness facing modern pharmaceuticals and the place pills and tablets suffer most in distribution: the internet.

A minimum of 11% of all online sales are counterfeit, and to date, Operation Pangea has taken thousands of offending websites offline and seized millions of counterfeit drugs. Their work is invaluable when we consider that roughly 35,000 online pharmacies have appeared in the last ten years or so — that’s a huge number of potential counterfeit operations.

The World Health Organization (WHO) and IMPACT

The WHO is another global operation with a focus on cutting off illicit tablets and pills at the source and highlighting how exacting counterfeiters can be with fake pill and tablet packaging. Often, it’s only a difference in color that gives a fake away (as in the second image on this page), and sometimes not even that difference exists. All but the most vigilant and prepared user could be fooled.

I briefly mentioned the International Medical Products Anti-Counterfeiting Task Force (IMPACT) in my previous blog. This arm of the WHO has operated since 2006 to combat counterfeit drugs across all member states, coordinating international activity and helping the private sector and public authorities protect public health.

However, IMPACT’s far-reaching powers fall short because they don’t protect a brand’s intellectual property rights (item 10). I’ve written in my previous blog on how vital IP protection is, why a security solution isn’t complete without it and how U-NICA's solutions can protect IP effectively.

A further weakness lies in the WHOs current surveillance system. While impressive, it’s severely limited by relying on passive reports to a site that’s unavailable to the general public health community. This makes it more difficult for the “man on the street” to help professionals identify counterfeit drugs.

The Food and Drug Administration (FDA)

The FDA is equally concerned with the extreme vulnerability pills and tablets face online, and it publishes several resources to protect consumers. Some of the most helpful are the Counterfeit Alert Network (a coalition of health professionals and consumer groups), their current standards for securing the pharmaceutical supply chain, and their industry guidance on incorporating physical chemical identifiers (PCIDs) into oral drugs.

The FDA is also in the process of enforcing the Drug Supply Chain Security Act, but it’s proving a laborious process that has years ahead before all medical manufacturers are brought into compliance. In the meantime, that leaves pills and tablets vulnerable throughout the supply chain.

Are Tablets and Pills Safe from Counterfeiters1

The counterfeit drugs statistics so far

It’s a troubling testimony to the tenacity of counterfeiters that the combined efforts of all the above are still not enough to eradicate fake pills and tablets. North America, Asia and Europe are still huge counterfeit hubs. Commercial medical counterfeits are still most of the market, but non-commercial medicines — free drug programs offered to financially struggling patients — are not far behind.

In my next blog, I’ll go deeper into pharmaceutical anti-counterfeiting and discuss how Track and Trace and aggregation are deployed to keep pills and tablets safer. You’ll also learn what U-NICA can do to help support the weaknesses of those two methods and help medical manufacturers, authorities and customers secure the supply chain issues I mentioned today.

In the meantime, you can reach me at the link below to learn more about U-NICA's commitment to crushing counterfeits of all kinds.

U-NICA is a team with a single purpose: supporting you in the fight to protect your brand’s integrity and value. Our staff operates globally and partners with universities and agencies to deliver the future of brand protection. Connect with me for more information on our constantly evolving open solution suite.