Counterfeit medications account for a $75bn market, according to the World Health Organization – and while the problem isn’t new, new innovations are emerging with which to fight back.
To learn more about the state of the counterfeit industry, Outsourcing-Pharma.com talked with Bob Miglani, the chief of business development at Applied DNA Sciences, a company which is currently using botanical-DNA technology to mark pharmaceutical products at origin to ensure authenticity, track and trace, fight counterfeits, and provide proof of origin.
Outsourcing-Pharma.com: What is the state of the counterfeit drug market?
Bob Miglani: Estimates for counterfeit medicines vary by continent and country. What we do know for sure is that there are two factors that influence the level of counterfeit or spurious medicines on the market. One is price. The higher the price of a medicine, the more it is likely to get counterfeited because illegal traders are attracted to higher profits.
Two is the fragmented global nature of the global pharmaceutical supply chain. The more ports or points a medicine has to touch around the world, the more likely illegal traders will attempt to insert a counterfeit box of medicine into the supply chain.
Also, there has been considerable progress in defeating those who make counterfeit medicines but the problem is not going away. In fact, it is going to get worse because of the rapidly changing nature of global supply chains as well as more advanced technologies being used by illegal traders.
Outsourcing-Pharma.com: Why is the supply chain one of the greatest reasons counterfeit medications continue to leak into the world marketplace?
Bob Miglani: It's not just the supply chain that is responsible for counterfeit medicines leaking into the hands of the marketplace. The lure of high margins for illegal traders and counterfeiters is just as much responsible. Also, the supply chain is highly fragmented and global.
For instance, active pharmaceutical ingredients (APIs) are produced in India in one month and then sourced from China or Brazil in another month. Then they are packaged in Singapore or Belgium or Indiana another month. It's the complexity of the supply chain that makes it challenging to have certainty or control.
Outsourcing-Pharma.com: What are new ways the industry is working to fight against counterfeiters?
Bob Miglani: Most pharmaceutical companies today are rapidly adopting new technologies as a result of the serialization mandate by the U.S. Food and Drug Administration, China, Turkey and other countries. From traditional bar codes to holograms on packaging, companies are deploying new technologies more rapidly than ever. Many of these work well and are easy to deploy but none alone are fully secure.
That's why we look at this as a team sport—where multiple technologies can be deployed to deter counterfeit medicines to ensure patient safety. Our Molecular Tag, for instance, can be deployed within traditional 2-D bar codes to make them stronger and forensically resilient.
No single technology can solve this problem of counterfeit medicines. Pharmaceutical companies will have to have a full menu of options that they can deploy concurrently. Doing so will allow companies to reduce their risk and increase patient safety.
Outsourcing-Pharma.com: Could you speak to the CMOs’ role in helping to solve the issue?
Bob Miglani: CMOs play a pivotal role in helping to solve this problem. First, CMOs can innovate at the beginning of the process by deploying new technologies in advance of problems occurring. It's actually more helpful to deploy new technologies before a problem occurs because they can help reduce risk for themselves and their pharmaceutical company customers.
Second, an emerging trend that we've seen in other industries is the development of a brand from a CMO point of view. In the world of commoditization of everything, some are deploying innovative approaches to build out their own brand with new technologies deployed inside.
In the cotton industry, a new brand called PimaCott was introduced recently that allows a branding of a new cotton fiber that utilizes an anti-counterfeiting technology inside it. What a cool innovative way to think about branding!
Offering something new to customers to prevent problems and reduce risk is a great way to grow the business for CMOs.
Outsourcing-Pharma.com: Any other comments?
Bob Miglani: With new regulations of trade between countries when it comes to sourcing of raw materials, companies will need to find innovative solutions to help increase patient safety. We're living in highly complex and unpredictable times, which require innovation to ensure future growth and reduce risk.
By adopting new technologies, we can not only ensure growth for CMOs and pharmaceutical companies, we can also ensure that the patient that takes her medicine every night goes to bed with the confidence that her medicine is safe and effective.