Implementing track and trace solutions in a dynamic environment such as India takes planning and forward-thinking precision. While the Indian government requires Indian pharmaceutical companies to comply with the Drug Authentication Verification Application (DAVA) regulation, companies are also preparing to comply with the European Union Falsified Medicines Directive (EU FMD) and the United States Drug Supply Chain Security Act (US DSCSA) for their exports. While companies are very compliance focused, it is exciting to learn about the most sophisticated technologies in the world, and how they will impact the pharmaceutical supply chain.
Starting with compliance
Many regulatory agencies, like DAVA and FMD, require manufactured prescription drugs to be serialized and uploaded into a national medicines database. India is one of the largest providers of drugs globally. Therefore, it is critical that Indian pharma meet statutory deadlines like the November 26, 2018, DSCSA and the February 9, 2019, FMD. Fail to meet these requirements and Indian pharma economy will likely suffer.
Early adoption often leads to a gain in market share. Furthermore, serialization and traceability can provide companies with the ability to know every distinct entity within their supply chain, what each product is, and its make-up. Serialization paired with innovative technologies, like Internet of Things (IoT) technology, can offer additional value beyond that of traditional track and trace software. With the help of IoT, companies can pinpoint in real-time the exact location of a product, the temperature, the various routes and handoffs, and where the product ultimately ends up. Such on-demand end-to-end visibility has critical high-value implications.
The future with Blockchain, Artificial Intelligence, and Machine Learning
Traceability companies are unlocking the benefits of technologies like blockchain, artificial intelligence (AI), and machine learning (ML) to digitize the supply chain operations.
One of the most exciting innovations in supply chain at the moment is blockchain. Traceability companies, such as rfxcel, are actively working to pilot blockchain efforts. We believe that track and trace systems provide the perfect environment to experiment with blockchain. Because blockchain is a secure immutable technology that operates through a peer-to-peer network, our solutions have established ecosystems to allow only credentialed trading partners to participate in the medicines supply chain. While the data is currently being passed via web services with AS2 or EPCIS, these regulatory ecosystems have demonstrated that there can be a trusted partner environment with clear handoffs. Once regulations are fully implemented, and the trading partner ecosystems are connected and collaborating, blockchain technology will start maturing for the pharmaceutical supply chain.
Digital supply chain is also being affected by artificial intelligence and machine learning. Track and trace and compliance efforts have led to enormous amounts of data, too much for humans to decipher and make decisions. We’re actively working with our customers to help them implement artificial intelligence to use their data predict issues. Paired with machine learning, systems will correct issues by making decisions without human intervention. Pharma companies will see faster and fully optimized operations, including demand forecasting, intelligent logistics, course corrections, anticipatory ordering.
Compliance – everything to gain and nothing to lose
We encourage the industry to view compliance as the key to unlocking enumerable supply chain benefits. The future beyond DAVA, DSCSA, and FMD compliance is exciting, but companies must first achieve compliance before they can get to the good stuff. And selecting the right solution provider is the key.
This article contains a client of an ESPACIO portfolio company.
About the author:
Vikash Pushpraj is the Senior Vice President in charge for Professional Services, Cloud Operations, and Customer Success of rfxcel. Before joining rfxcel in 2017, Vikash spent many years successfully leading departments of product development and customer success at a number of Fortune 500 software companies, such as PTC and Autodesk, where he was responsible for a product portfolio that generated $600+ million annual revenue. Vikash also has entrepreneurial experience from a number of successful start-ups and brings a renewed sense of vigor at rfxcel, often stressing the importance of time management and urgency in providing overall customer success.
Founded in 2003, rfxcel is one of the first companies to focus on the safety of the pharmaceutical supply chain and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers. rfxcel’s mission is to be the thought leader in traceability technology for Life Science, Food and Beverage and other industries. rfxcel enables customers to better manage their business today and deliver value tomorrow. For more information, visit https://www.rfxcel.com