The global pharmaceutical market has witnessed major regulatory shifts in recent years to secure the drug development supply chain. Countries across the globe are adopting uniform regulations that bolster enhanced visibility, track and trace, and safe manufacturing practice. These initiatives should come as no surprise: industry expansion and growth— both in the US and in global “pharmerging” markets—is beneficial but can also prompt counterfeiters to take advantage of vulnerabilities in the supply chain system. In other words, heavy growth in pharma across the globe also means more instances and/or attempts of drug counterfeiting.
Accurate, efficient, and high-quality labels play a crucial role in streamlining the supply chain and discouraging drug counterfeiting. Manufacturers must be prepared to tackle the increasingly complex supply chain, by using reliable technologies that enable a safe and high-quality labeling process without compromising production timelines, cost, or company credibility.
Rise in Pharma, Rise in Counterfeiting
The pharmaceutical market is projected to grow by 5.1 percent annually over the course of the next five years, with total global spending set to reach $1.2 trillion in 2017.1,2 To remain active in an increasingly competitive industry, companies are investing heavily in growing, global markets. But as the market for life-saving medicines and pharmaceuticals expands, rising incidences of drug counterfeiting increase the potential risk of harm to patients. At least 10 percent of all pharmaceuticals across the globe are recorded as counterfeit, with select developing countries experiencing jumps as high as 30 percent.3 Manufacturers looking to turn global promise into profit, while also protecting patients, are tightening up anti-counterfeiting regulations and serialization practices.
In the U.S., the rise of drug importing and exporting led the charge for harmonized serialization mandates, which took shape through the FDA’s Drug Quality and Security Act (DQSA). Meanwhile across the globe, the push for a more secure drug supply chain has resulted in regulations such as the EU Directive on Falsified Medicines + Delegated Act—intended to preempt instances such as in 2011 when EU authorities apprehended more 30 million counterfeit drugs at borders.4 In light of these policies, manufacturers and distributors must adopt new standards—and technologies—within relatively short timelines.
Closing the Gaps
The rapid growth and globalization of the pharmaceutical industry gives way for even more holes in the supply chain. Gaps in drug movement can occur from pharmaceutical manufacturers to distributors to point-of-purchase distributors, such as hospitals or pharmacies. However, drugs may also move laterally from authorized distributors to trade brokers or secondary wholesalers—further adding to the risks.
Counterfeit drugs often result in product recalls and liability issues that can significantly impact revenue and brand credibility.5,6 As a result, companies are investing in better business practices and improved anti-counterfeiting technologies that help secure parts of the process at the system level, facility level, and individualized product level.7 Manufacturers and distributors however, require technologies that easily integrate into preexisting workflow and can streamline in-house production—providing a quicker, convenient means of producing better quality labels that can help prevent counterfeiting.
Simplify Inventory Management
Counterfeiters—who already benefit from fragmented global regulations—are also enabled by facility-level mismanagement. Non-compliance with Good Manufacturing Practices (GMP) can lead to overstock—ultimately resulting in product expiry and added waste. Maintaining large inventories is cost ineffective for a number of reasons, including risk of increased product excess due to expiry dates. This level of management adds complexity that when compounded by human error, opens the door to further delays or production inaccuracies. On-demand color printing produces labels as needed, minimizes excess label inventory, and reduces labeling costs by approximately 50 percent. By reducing the amount of in-house overstock, there is less room for confusion along the production line.
Improve Production Flow, Reduce Waste
Real-time label production eliminates the need for pre-print labels—making management more feasible through less buildup of overstock or label waste, and significantly reducing lead time. Shorter lead times can minimize the frequency of product or shipment error as well as overall delays in supply chain production. Manufacturers and distributors can also adhere to the principles of First-Expired-First-Out (FEFO) with a smoother production flow, less build up on the shelves, and less waste produced.8,9 Technologies that enable manufacturers to efficiently carry out the FEFO method of inventory management ensure safer drug production, deployment, and end-use, while also reducing the possibility of counterfeiting. Ultimately, products that are more readily available help reduce in-house complications, closing up potential (and often overlooked) gaps for drug counterfeiters to take advantage.
Recognize the Role of Color
Labels produced in color (using pigmented ink) minimize errors in medical identification, improve the overall process of accuracy, and can make the process of counterfeiting more challenging. In one instance, the FDA found that counterfeit drugs en route to the U.S. had differences in patterns and shading, as well as misinformation in color boxes when compared to the original brand.10 By differentiating each label, brand, or marker with color labels, companies can take preemptive steps in protecting their products and credibility while also making it more difficult for counterfeiters to easily replicate drug labels. Increased use of color labels could also deter potential counterfeiters who would have to invest in costly technologies to even try and mimic a particular drug label with multiple markers. Color labels that draw attention to specific details make it easier to both read and identify any differences in graphics or information—improving the overall process of immediately recognizing an original drug and its counterfeit.
Work with Durable Technology from a Credited Supplier
Manufacturers should partner with label technology suppliers who incorporate pigment ink into their color on-demand label production. Pigment inks improve label durability and security by resisting fading and smudging due to water or chemicals—ensuring that barcodes and graphics remain intact. Inventory management and the process of recognizing counterfeits can be improved at the ground level with high-quality color labels and precise barcodes that won’t smudge or smear.
Suppliers who take it one step further with third party testing, such as ensuring BS-5609 certification for their product line, provide even higher quality labels capable of withstanding a three-month long exposure to salt water. Certified labels that are continuously tested enable suppliers to better recognize any possible label alterations, and provide manufacturers with precise labels that have ultra-sharp text and recognizable graphics. Manufacturers working to secure their facility, and companies working to secure their line, require durable, high-quality technologies that can also streamline in-house management and production.
The industry has recognized how fragmented regulations set up a landscape for counterfeiters to take advantage, and responded to this growing challenge by implementing harmonized regulations. However, manufacturers must now work toward implementing these mandates into their facilities and production lines. Color on-demand labeling technology can improve compliance and efficiency, while also minimizing the threat of counterfeiting due to facility-level mismanagement and unit-level errors. Label printers that provide enhanced text and image quality while streamlining the overall in-house production process, enable better unit, facility, and system-level security—benefiting companies, brands, manufacturers, and ultimately patients in the long run.