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Manufacture Business Practice, Technology and Equipment, Trends & Forecasts

Wake Up to Smart Serialization

Counterfeiting is a low-risk, high-reward crime for the perpetrators, which makes it a huge challenge when it comes to many consumer products; the difference with pharmaceuticals, of course, is that counterfeit medicines can kill you. Don’t be fooled into thinking that counterfeiting affects only those buying drugs online or from a disreputable source; statistically, the likelihood is that we’ve all taken counterfeit drugs – according to the WHO, the FDA estimated in 2003 that counterfeits made up more than 10 percent of the global medicines market and were present in both industrialized and developing countries.

The advent of the global supply chain, online pharmacies, and the ease with which counterfeit drugs can now enter the market have led governments to introduce increasingly stringent regulations on track and trace. In the US, several states brought in their own legislation, ahead of the federal government deciding a single law was needed. The Drug Supply Chain Security Act has a phased roll out, with serial codes required on all products by 2017 and aggregation with product traceability by 2023. Brazil is moving faster, with full serialization, aggregation, tracking and tracing required by the end of 2016.

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