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The pharmaceutical industry was one of the first industries to recognise the efficiency of serialisation and Track & Trace technology for supply chain protection from counterfeiting and grey products. With the "Traceable Quality System" (TQS) product line, WIPOTEC-OCS has successfully supported pharmaceutical companies in their projects. The high-tech engineering company is now working to adapt its high-performance serialisation solutions to the requirements of non-pharmaceutical industries.
Anti-counterfeit measures through product serialisation laws triggered the significant transformation of the healthcare industry, turning regulatory compliance into the top priority in 2018. With EU FMD and the US DSCSA regulations coming into force, pharma manufacturers around the globe have accelerated their compliance efforts. Due to progressing globalisation of the healthcare markets, the European and US regulations affected companies even in countries that do not require serialisation on the national level. WIPOTEC-OCS registered high market demand for serialisation and aggregation solutions globally and reports implementation of more than 2000 Track and Trace projects in the pharmaceutical industry by the end of 2018.
Global regulatory landscape demonstrates that the transition of the healthcare market will continue on the global scale. For production management, it means that packaging lines have to be flexible enough to support different serialisation and coding specifications of multiple markets. Regulatory compliance involves substantial investments into advanced systems and equipment and even replacing or modifying the existing packaging lines.
The problem of counterfeiting is unfortunately not limited to the healthcare industry only. Increasing globalisation of trade and inadequate control with low penalties for trading falsified products in many countries encourage the rise of global counterfeit activities. However, the issue of counterfeiting is not only a problem for the brand owners, whose products are being affected. In cosmetic, food and agrochemical industries it poses a risk to health and the environment, as the counterfeit products are not subject to safety regulations that original products are. Alone in the agrochemical sector, Europol estimates the share of counterfeit and unauthorised pesticides to comprise as much as 14% of the EU market. The organisation sized 360 tons of illegal pesticides in 2018. According to the research conducted by the European Union Intellectual Property Office, EUR 1.3 billion is lost across the EU due to counterfeit agrochemicals.
These figures demonstrate that even a substantial initial investment in tamper-proof and anti-counterfeit technology will result in a high return on investment, regulatory compliance and competitive advantage in the longer run. Among all anti-counterfeiting solutions on the market, serialisation proves to be one of the most effective ones. The technology is giving manufacturers, wholesalers and distributors a systematic approach to detecting counterfeiting and control product diversion. The pharmaceutical sector serves as a valuable example of how serialisation and Track and Trace technology can effectively ensure product integrity and supply chain transparency.