Pharma Security World 2019 - Anti-Counterfeiting, Drug Serialization and Supply-Chain Security Conference

The importance of the pharmaceutical industry in the modern-day society cannot be overstressed especially as there are new diseases springing up from different areas, strengthening the importance of adequate drug research and development activities. However, with the growth of the industry, comes the increase in fake drugs. In recent times, these products are still being produced and passed down to consumers in large quantities amidst the impact of the various counterfeiting hubs that have been seen to operate on a global scale. According to World Health Organization (WHO), about ten to thirty percent of the pharmaceuticals distributed to most third world countries are fake and this industry is growing at an alarming rate, even faster than legitimate pharmaceutical companies raking in about $217 billion yearly in sales. No nations stay untouched by this issue, what was once viewed as an issue endured by developing nations has now turned into an issue to developing nations including US and Europe. We require both countrywide and industry-level participation, and in addition public and private sector coordinated effort, to identify and definitively battle counterfeiters. The upcoming regulations are meant to secure the pharmaceutical supply chain and comes as a result of rising drug related criminal activities and supply chain inefficiencies.

The US is driving the path with the Drug Supply Chain Security Act (DSCSA) approved in 2013. DSCSA guide for end-to-end traceability is extended over a period of 10 years, with expectations sketched throughout the supply chain. The complete supply chain is relied upon to be electronically incorporated and all hubs of traceability to be built up by November 2023. The E.U.’s Falsified Medicines Directive requires drug companies to adopt mass serialization and other anti-counterfeiting measures starting in 2019. Manufacturers who operate in the E.U. will have to add unique identification numbers to the outer packaging of all prescription drugs, and equip containers with tamperproof seals. To guide customers from illicit online drug stores that supply fake medications, the FMD requires approved legitimate Internet drug stores to show a logo distinguishing them as E.U. approved drug retailers.