As people continue to become more and more health conscious, they are adopting healthier lifestyles, which helps to increase life expectancy. In turn, this has led to a greater demand for pharmaceutical products required for the growing number of elderly people. Couple that with the current patent cliff — the expiration of patents for a number of blockbuster drugs — and the demand for pharmaceutical packaging machinery remains high. Meeting the demand for machinery will not tax the industry, but the increased regulation of pharmaceuticals does make it more challenging, according to the 2016 Global Trends Impacting the Market for Packaging Machinery, from PMMI, the Association for Packaging and Processing Technologies.
Throughout the world, there is legislation either in place or coming down the pike to ensure a strong internal risk framework. The report addresses the largest laws and offers specifics on remaining compliant.
Here in the U.S., the Federal Government passed the Drug Quality and Security Act (DQSA) in November 2013. The law serves as an initial step to combat the large and potentially life-threatening market for counterfeit drugs. This created a national (rather than statewide) regulation for pharmaceutical serialization and track and trace, and requires primary and secondary packaging of pharmaceutical goods to have serialized coding. DQSA comes into force for manufacturers in 2017, with later deadlines for re-packagers and wholesalers. The study further predicts that while this legislation is directed at the U.S. market, the impact will be felt equally in Mexico and Canada, both of which export heavily to the U.S.
In the European Union, the Falsified Medicines Directive (FMD) necessitates the need for serialization of packages to enable traceability of drugs throughout the supply chain. This includes the mandate that packaging must include 2D codes. The deadline for meeting the FMD legislation has been extended from the start of 2017 to the start of 2018 to allow companies to implement fully and comply.
The desire to trace drugs from processing through packaging and on to consumers is also a key focus in developing regions. Since 2011, the China Food and Drug Administration (CFDA) has been gradually implementing its Electronic Drug Monitoring Network. The network is part of China’s plan to enable traceability of all drug products through the supply chain. The government assigns serial numbers centrally and all transactions from manufacturing to dispensing must be reported. The legislation required all domestic and foreign drug manufacturers to begin using the network before Jan. 1, 2016.
In Brazil, RDC 54 requires serialization at item level and transportation container level, as well as aggregation relationships between case and unit, to be fully implemented in the pharmaceuticals supply chain by December 2016. Manufacturers must track all products through the supply chain (even those supplied to companies that they do not have a direct relationship with) and report shipments to ANVISA (Brazil’s National Health Surveillance Agency.)
To facilitate the legislation, there must be effective management and information at each stage of the often-complex supply chain. This has led (and will continue to lead) to investment in new machines as end users upgrade production lines. There is also a growing demand for improved integrated, software-based solutions, a trend that is predicted to continue for the foreseeable future.
For a full copy of PMMI’s 2016 Global Trends Impacting the Market for Packaging Machinery go to pmmi.org/research.
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 700 North American manufacturers of equipment, components and materials for processing and packaging. We work to advance a variety of industries by connecting consumer goods companies with manufacturing solutions through the world class PACK EXPO portfolio of trade shows, leading trade media and a wide range of resources to empower our members. The PACK EXPO trade shows unite the world of processing and packaging to advance the industries they serve: PACK EXPO International, PACK EXPO Las Vegas, Pharma EXPO, PACK EXPO East, EXPO PACK México, EXPO PACK Guadalajara and ProFood Tech, launching in April 2017.PMMI Media Group connects manufacturers to the latest solutions, trends and innovations in processing and packaging year-round through brands including Packaging World, Automation World, Healthcare Packaging, Contract Packaging and Packaging + Processing OEM. PMMI Business Drivers assist members in pursuing operational excellence through workforce development initiatives, deliver actionable business intelligence on economic, market and industry trends to support members’ growth strategies, and actively connect the supply chain throughout the year.