How has Systech evolved since the Markem-Imaje acquisition?

Two years ago, Systech was acquired by Markem-Imaje, a Dover Company. We had been focused on the pharmaceutical industry for over two decades with 19 out of the top 20 pharmaceutical companies in the world being Systech customers. We started as a pharmaceutical packaging execution system, with a focus on machine vison and inspection of things going through pharmaceutical manufacturing, verifying that products are properly coming off the production line. Systech got involved in pharmaceutical serialization at its germination point in the US, with California ePedigree in 2005. We then evolved with the FDA, which transformed state by state pharmaceutical regulation into the Drug Supply Chain Security Act (DSCSA). This act has had different bells to ring over the past five years with one more being implemented in 2023.  

DSCSA impacts compliance needs for every pharmaceutical manufacturer in the US. Companies are required to have serialized products, and additionally, there is a salable returns requirement to validate that the products being returned are fine for resale.

Systech will remain focused on continuous innovation of our offerings, while leveraging the global reach of Markem-Imaje, with the ultimate goal of continuing to provide state-of-the-art brand protection solutions to our customers worldwide. We see the combination of Systech’s solutions with Markem-Imaje’s products, services and global reach enabling Systech to enhance R&D, expand global reach and provide higher levels of service to our customers.

Has there been an increase in counterfeit drugs on the market through pandemic years?

It is scary that the number of counterfeit drugs on the market has significantly increased over the past two years. With the pandemic, there has been a normalization of pharmaceutical distribution from online platforms, which is an easy way for counterfeit manufacturers to get their products into legitimate looking online marketplaces. Counterfeits can exacerbate health issues or even cause death.

Another important element in the pharmaceutical gray market is diverted products. Pharmaceuticals are offered at different price points based on different geographies and sometimes medicines are offered at very low costs, but still must go through the legitimate supply chain. These medicines get diverted and placed into the gray market, often distributed on online. There are incredibly strict supply chain realities, but once products are diverted out of the legitimate supply chain, lack of proper handling can heavily impact the efficacy of the medicine.    

The pandemic has created the perfect storm for counterfeiting as no one knew what COVID-19 related products looked like and where they would be available. It started with counterfeit test kits followed by counterfeit vaccines appearing online. Governments did a good job mitigating this but could have done better informing the public that no legitimate vaccines for the COVID virus would be available online.

How efficiently can we monitor and trace supply chains from production to pharmacy today?

We can effectively track and trace pharmaceuticals from manufacturing or contract manufacturing to the McKesson’s and Cardinal’s of the world. DSCSA 2023 is really about going to the next level where we can trace and track products to dispensaries, pharmacies and doctors. The vision of DSCSA 2023 is the notion of an interoperable supply chain where any node within the pharmaceutical distribution world can be tracked and traced and we can facilitate any action and reporting we want. The model is based on aggregated serialization where, for example, if you have a serialized ‘each’, it gets placed into a serialized case, which then gets placed on a serialized pallet… and with one scan of the pallet at a distribution center everything moves in tandem. The Systech team is participating in a group called the Partnership for DSCSA Governance (PDG) where it is in an ongoing buildout of what the entire interoperable supply chain looks like from a technology standpoint.

How do different country regulations impact the traceability of drugs?

At the end of the day, it’s all the same, but slightly different. It’s about having a serialized product, individually identifiable, with the data available—for the intended market. The difference in regulations from country to country is the openness of the data. For example, the EU Falsified Medicines Directive (FMD) requires the serial number to be validated when it is manufactured and then only again when it is dispensed. There are many things that can happen throughout the pharmaceutical supply chain between manufacturing and dispense. The US FDA recognized this, and is thus implementing a regulation where products are tracked and traced throughout the entire supply chain.  

What is Systech’s vision for growth for 2022 and beyond?

First is ensuring our Systech customers are compliant with DSCSA 2023 regulations.  In terms of the interoperable supply chain we are participating with the PDG to stay on top of how the industry is going to design and comply with the 2023 mandate. Second, while serialized barcodes on packages have a digital component, they are essentially printed elements that can be copied, fabricated and reproduced. With our vision technologies and expertise, we are able to create a double layer of product protection. We derive a unique, digital e-Fingerprint® from that serialized 2D code which can be used to authenticate the product anywhere in the supply chain. In addition to validating the serial number, it verifies if that printed code actually came off the legitimate packaging line. We provide operational information that empowers our clients to secure their products and reduce the opportunity for counterfeiting—all with a simple smartphone app.