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Clinical supplies & logistics Seeking value in O


ver the years, the growth in counterfeit medicines in the supply chain has been a tangible threat, not only to patient safety, but also the profitability of pharmaceutical companies. According to a report by Statista in 2020, the market for counterfeit prescription medicines resulted in a loss of $200bn to the industry. That kind of financial loss, the report notes, may prevent as many as 13 new drugs from coming to market each year. Furthermore, the US National Crime Prevention Council estimated in 2021 that more than 10% of all pharmaceuticals in the global supply chain are counterfeit. One of the key weapons in the fight against fake drugs is


The concept of serialisation was primarily a response to the counterfeit drug challenge of the early 2000s. Though technological advances and regulatory development never fully resolved this problem, the tools pharmaceutical companies employed have delivered value in other areas, and serialisation can do more than simply appease the regulators. Jim Banks speaks to Courtney Soulsby, global


director, healthcare sector at British Standards Institution (BSI) to find out how pharma companies can leverage serialisation to extract business value.


serialisation, which requires the placement of unique markings – principally batch and lot numbers – on primary packaging. This provides the visibility to highlight the presence of counterfeit drugs or the diversion of real medicines from their intended destination. Whether they are in the form of barcodes or radio-frequency identification (RFID) tags, these markings can localise a specific item along its passage through the global supply chain. “I’m a supply chain traceability expert, so I understand how to leverage serialisation, and I agree the driver was to achieve visibility into where medicines go and, as a side benefit, to allow companies


serialisation


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Clinical Trials Insight / www.worldpharmaceuticals.net


olesia_g/Shutterstock.com


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