[Peter Hermes Furian/Adobe Stock]
The financial toll for pharmaceutical companies and healthcare systems is considerable.The Pharmaceutical Security Institute’s data shows there were 5,081 incidents of pharmaceutical counterfeiting, illegal diversion and theft in 2019.. The figures dipped somewhat in 2020 to 4,344 incidents, likely as a result of the pandemic. Of the events that occurred in 2020, most (1,579) were in North America followed by Asia Pacific (1,151). The scope of the problem could potentially.
A recent conversation with Sreedhar Patnala, general manager at Systech, highlights strategies to effectively tackle counterfeiting. Patnala describes a comprehensive programmatic approach, rather than a solely technology deployment. Core elements include aligning strategy, technology, organization, training and resources across stakeholders in the supply chain.
In the following interview, Patnala shares his insights on the evolution of the counterfeit drug trade, best practices in pharmaceutical traceability and why a holistic approach encompassing people, processes and technology is critical to stay one step ahead of sophisticated counterfeiters.
What are the key challenges the pharmaceutical industry now faces in terms of counterfeit products, and how has this problem evolved in recent years?
Sreedhar Patnala
Patnala: Counterfeit drugs have been around for a while, but they have become more prevalent due to the emergence of advanced counterfeiting technologies and the rise of e-commerce marketplaces and digital retailers. Their broad reach, combined with a general absence of oversight, makes online platforms the perfect stage for illicit activities with a significant impact on the global economy. The consequences of selling counterfeit and diverted products are far-reaching, and as solutions evolve, so does the sophistication of the bad actors and their criminal schemes, creating an even more significant challenge for the industry.
What are the common traceability methods pharma companies use to protect the integrity of their products? What changes do you think pharma firms should make to stay ahead of counterfeiters?
Patnala: Pharmaceutical companies today use overt and covert anti-counterfeiting technologies, both physical and digital, and often combined, to offer layered protection. However, anti-diversion and anti-counterfeiting require a programmatic approach, not just technology deployment. This approach requires key stakeholders to align strategy, technology, organization, training and resources to prevail against counterfeiters. Collaboration across the board is critical to help identify, trace and authenticate the right products. Sharing data on suspicious products and counterfeit trends can bolster detection. Collaborating with companies fighting counterfeits in other sectors and leveraging their learnings can also be beneficial.
What’s your perspective on how pharma companies can ensure they have end-to-end supply chain visibility?
Patnala: In today’s era, consumer trust is crucial to a brand’s success. Real-time tracking capabilities are critical in verifying product authenticity and origins, fostering consumer faith and loyalty. While it’s still evolving, Industry 4.0, i.e., the 4th Industrial Revolution, is already significantly impacting our clients’ businesses by enabling smarter factories and helping manufacturers deliver high-quality products throughout their supply chains. The information these advanced technologies provide can help streamline manufacturing operations, connect supply chains, inform decision-making and enable faster response time to unplanned supply chain events.
Industry 4.0 also lays the foundation for enhanced product traceability, a critical aspect of supply chain management that aligns with Drug Quality and Security Act (DSCSA) requirements. It facilitates exact tracking and tracing of products throughout the supply chain, from manufacturing to end-user delivery. Combined with additional digital layers of protection, it helps combat diversion and counterfeiting that harm patients and eventually brands.
However, the biggest challenge is not technology, it requires participation of various stakeholders in the supply chain to have an effective anti-counterfeiting program. Large companies promote collaboration and incentivize these stakeholders to achieve true end-to-end visibility. They also use technology to ensure multiple stakeholders are aligned. Other aspects, like data protection, facilitate data sharing.
No single product will end the gray market and wipe out counterfeiters. A combination of people, processes, technology, and time is critical to ensure patient safety and loyalty and to protect brands.
Beyond preventing counterfeits, what are some other benefits of implementing a comprehensive traceability system for pharmaceutical products (e.g., optimizing inventory management, facilitating recalls, etc.)?
Patnala: Traceability technologies can provide several additional benefits beyond enhanced safety. Manufacturers can gain valuable data that helps predict shortages and improve supply chain operations. In an industry where consumer safety and market stability are at risk due to counterfeit and diverted products, traceability systems offer a competitive advantage.
In terms of patient health and safety, traceability systems enable the identification and timely removal of defective or potentially harmful products from distribution, allowing for efficient recalls and minimizing patient impact.
Furthermore, in a time where patients and providers are increasingly aware of product quality and safety, supply chain traceability plays a crucial role in fostering stronger relationships between manufacturers, distributors, healthcare providers, and end patients. Consumer access to the product journey builds trust and brand loyalty.
What are some of the most successful case studies or examples where Systech’s traceability approach has helped pharmaceutical companies combat counterfeiting?
Patnala: International pharmaceutical manufacturer Takeda faced the task of implementing serialization and aggregation on over sixty globally distributed packaging lines. They were looking for a global vendor that would be able to create a standardized and repeatable process for Takeda’s unique product identifier (UPI) — or track and trace — project. Configurable software, zero custom code and deep domain expertise were required to get the job done properly and to reduce down-time of packaging lines.
The Takeda and Systech partnership started with a pilot in Brazil, to deploy serialization and aggregation across all lines there. The project was successful, and Takeda made its broader corporate selection based on the experience in that region. There were also joint projects following in Taiwan, managed out of Japan, which led to the decision for Systech.
Systech met Takeda’s expectation with an easy configurable software and a fully standardized packaging line set-up including all hardware components. In addition, they offered a robust set of implementation configuration documentation, based on thousands of line implementations Systech has been involved with. Takeda and Systech finally developed a standardized, repeatable team process for all line projects.
How do you see the role of traceability evolving in the pharmaceutical industry over the next 5-10 years, and what are some of the emerging trends or technologies that will shape this space?
Patnala: In the next 5-10 years, we will have a broader understanding of complete end-to-end supply chain visibility for all stakeholders. It will be augmented with new regulations to facilitate better traceability and combat diversion and counterfeiting.
Systech sees artificial intelligence and machine learning playing a significant role in the future fight against counterfeit drug production. Advanced solutions encompass a range of technologies designed to guarantee the authenticity of pharmaceutical products from production to point of sale, providing intelligent guidance for users during the authentication process.
Sophisticated tracking systems enable manufacturers to monitor their products’ journey through the supply chain. This tool is essential for pinpointing and mitigating instances of diversion or unauthorized distribution. Additionally, by leveraging existing 1D and 2D barcodes and packaging, digital authentication technologies provide a non-replicable, non-additive solution for verifying product authenticity. Utilizing an easy-to-use smartphone application, brands and their trading partners can instantaneously verify product authenticity—anywhere in the supply chain, providing an additional layer of security against counterfeiting.
Implementing these next-generation technologies is the next step toward securing the pharmaceutical supply chain and ensuring that medications reaching patients are safe and effective.
Filed Under: Industry 4.0, Regulatory affairs
