SPOTLITE360 BEGINS PHARMACEUTICAL INDUSTRY INITIATIVE FOR SUPPLY CHAIN TRACKING, TRACING, AND SUSTAINABILITY
Spotlite360 Technologies Inc. has launched an initiative to offer tailored supply chain tracing and tracking solutions for organizations in the pharmaceutical industry, for which it is presently in contract negotiations with pharmaceutical firms. This initiative aligns with an impending U.S. regulatory change in the USD $1.3 trillion pharmaceutical industry1 requiring companies to comply with the Drug Supply Chain Security Act ("DSCSA"), which mandates the implementation of electronic tracing measures. The Company has identified an opportunity to deliver solutions geared towards compliance with the DSCSA using RFID and IoT ("Internet of Things") sensors in conjunction with blockchain, machine learning, and enterprise tracking software licensed from TrackX Holdings Inc. ("TrackX").
"The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA's ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers."
Excerpt from the Food and Drug Administration webpage introducing the DSCSA and its objectives
In addition to the burden of compliance with new and emerging regulations such as the DSCSA, pharmaceutical industry players face other persisting challenges in their supply chains to include the following: Approximately USD $200 billion worth of counterfeit drugs are sold annually worldwide2 Pharmaceutical cargo theft amounts to more than USD $1 billion per year, with the median theft value of USD $100,000 being above average compared to other industries3 Deficient storage and transportation practices (e.g., unrefrigerated vehicles, shipping times exceeding a drug's shelf life) can cause damage to pharmaceuticals, identified as a multi-billion dollar problem in a 2018 study4
Empowered by the Spotlite360 technologies tailored to clients in the pharmaceutical industry, the Company's existing SaaS solution will be able to capture real-time and event-driven data which can identify inefficiencies and possible hazards for pharmaceutical firms, thus potentially mitigating issues such as those listed above. Further, by providing proof of origin, reliably authenticating goods, and allowing for visibility into the chain of custody, potential benefits to clients in the pharmaceutical industry include accountability of global suppliers, as well as validation of claims relating to environmental, social, and corporate governance ("ESG") matters.
Blockchain technology has already proven successful in various functions of pharmaceutical supply chains, including compliance with DSCSA. In 2020, a major technology firm published a study of its blockchain pilot program in collaboration with pharmaceutical giant Merck & Co. and the U.S. Food and Drug Administration ("FDA"), which was deemed initially feasible as detailed in its final report submitted to the FDA5. By offering an enhanced value proposition through comprehensive visibility and tracking capabilities, Spotlite360 seeks to create new industry standards with its latest initiative for the pharmaceutical industry.