Techniques for Securing the Supply Chain and Combating Counterfeit Medicines

The integrity of the pharmaceutical supply chain is an ever-evolving landscape. Predictive modeling and digital simulations are being used in transport validation to identify problem areas such asextreme temperature fluctuations and varying transit durations. Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about the variety of tools being utilized to protect the supply chain.

PharmTech: How are pharma companies using predictive modeling or simulation to design and validate transport conditions?

Parikh: Pharma companies are really relying on digital simulations to support transport validation, not to completely replace the physical studies, but the simulated data in general is being used a lot alongside the real-world qualification to be predictive, but also to understand what are the drivers of risk, what sort of stress conditions there are, and try and simulate those worst-case scenarios.

A lot of digital predictive tools are applied to simulate the extremes, whether they are about the temperature or variability in the conditions or the durations, and so on. But one of the things I heard was that hybrid qualification strategies are more prevalent than simulated results.

As digital authentication technologies (eg, serialization, smart labels, mobile/QR, or NFC-based verification) mature, what criteria are used to evaluate which solutions are truly scalable and GMP-ready?

[There is] a lot of talk about all the different types of digital tools, including use of AI, 2D barcodes, and phone apps to sort of scan and authenticate, for the patient at point in time. So, a lot of those are being worked upon in the industry.

It looks like having something in the hands of the patient, like a phone app that you can open your camera and scan a barcode on the product to authenticate it,

seems to be the most scalable solution.

Everyone has an Android, everyone has a smartphone, or an Apple phone. So, having those apps is definitely going to be probably the easiest, most scalable approach.

But alongside those, there are a lot of other technologies where they're trying to look at labels, making sure that the labels are verified, digitally, or they're using AI to predict the types of counterfeit areas that the people who try to counter-counterfeit would be using.

I think what we heard was that QR codes are going away, because it's easier to sort of counterfeit those, but 2D barcodes with digital footprints inserted into those 2D barcodes is something that a lot of organizations are moving into.

I think one of the biggest challenges even with using digital tools is the education and the awareness aspect. Because even if you have all of these tools, the mindset of the patient and doctors [might not be is] this product not authentic. I mean, when I take a medication, I'm not thinking whether or not it's authentic. I'm assuming it.

So, if I wasn't educated to actually use these digital tools, I wouldn't even be trying to authenticate the product.

So, there's some challenges even with the digital tools.

What can you tell us about the presentation you moderated at PDA Week in March 2026?

Well, there were two topics. One of them was talking about how do we get ahead of the game and be a little bit more predictive when it comes to tackling with counterfeit products.

We saw how, in a lot of parts of the world, especially some of the developing countries, where drug products are being counterfeited, you can see them being sold on websites like eBay, which are local to those countries.

And, they're getting smarter. The counterfeit folks are getting very, very smart with the way they counterfeit. They're using the same serial numbers as the original manufacturers, similar, expiration dates, same labels. They're using a lot of the available technology to make sure that the product appears to be sort of authentic, when it's not.

That's a big challenge, especially in some of those countries, and it's not always easy to partner with local authorities to crack that down.

From the other session, we also learned that there were 104 respondents for the PDA transport validation survey, and they unanimously agreed about the need for coming to an aligned solution as to what to do around transport validation.

But there's some challenges where regulators are slow to adapt.

The specific types of discussions around whether or not to use simulated studies, real-world data, those types of discussions are still where we're seeing less alignment.

So, there's a need for call to action, for the broader industry to sort of take this survey and, and act upon it and, and come up with some sort of a white paper or something like that.