Fighting pharma fakes using injection moulding techniques

Sumitomo (SHI) Demag explains how using thin wall moulding to apply the latest injection moulding precision techniques to step up their fight against pharma fakers to mitigate risks and safeguard brand integrity.

Pharmaceutical safety demands traceability. Yet, even with stringent serialisation standards and covert technologies like barcodes, holograms, sealing tapes, and radio frequency identification devices to preserve the integrity of the pharmaceutical products, counterfeiting remains a multi-billion-pound industry with bootlegging of devices and falsification of medicines and wellbeing products rife.

The pandemic added further to these pressures. High demand for PPE, test kits, broken supply chains and fewer physical audits amplified the risks of opportunists and illicit trade networks. The impact was significant reports the OECD. Enforcement authorities reported a sharp uptick in seizures of all types of medical products. During the height of the pandemic, the World Customs Organization supposedly seized 200 Covid-19-related products. In addition, the EU purported countless examples of substandard products, non-compliance and falsified certificates of conformity.

The economic cost of IPR infringement is huge and extends right across the world. In their most recent report, the European Union Intellectual Property Office (EUIPO) put the annual cost of fake medicines at €10.2 billion per annum. Equating to approximately 4.4% of sales across the sector in Europe alone.

These lost sales convert into direct employment losses. The EU calculates it at nearly 38,000 jobs. Although this doesn’t factor in imports. Nor the trade in counterfeit products via non-EU channels.

The dark web

Notably, the pharma and perfumery sectors incur the highest propensity for e-commerce infringements. As testimony to the scale of the situation, Interpol’s Operation Pangea XIV in May 2021 shut down more than 100,000 online market places, with over 70% of seizure cases at EU borders relating to Internet sales.

However, these are the visible parts that are being detected. The dark web is a whole different story with the repackaging of medicines resulting in even more complex and covert criminal channels.

Packaging specialist at Sumitomo (SHI) Demag UK Ashlee Gough examines how specialist closure and thin wall moulders can apply the latest injection moulding precision and In Mould Labelling (IML) techniques to step up their fight against these pharma fakes to mitigate risks, safeguard consumers and protect brand integrity.

It’s not just brand revenue through lost sales that suffers from counterfeiting. Illicit medicines can contain lethal ingredients, such as mercury, arsenic, rat poison or cement, which can be harmful when consumed. Others can just be ineffective. Lower quality cosmetics may cause skin inflammations. Causing consumers to lay the blame on authentic brands and diminishing brand equity.

Despite these widespread dangers, another survey of senior food and drink execs by assurance specialists The Lloyd’s Register, revealed that during the pandemic only a third vetted suppliers against a recognised GFSI standard. One in five declared that no checks were made as part of sourcing decisions. Yet, despite these prevalent risks – 97% stated that they’d been affected by fraud in the last 12 months - few in the industry regard authenticating products as their highest priority.

Regaining control

In a converted effort to crackdown on groups profiting from illicit pharma, wellbeing and cosmetic products, manufacturers are making labels more difficult to copy and bottles harder to refill. “One way to counteract counterfeiting and product tampering is through the innovative design of packaging that cannot be easily copied,” highlights Ashlee.

“Until recently, this may have involved putting shrink or foil sleeve around a pack or bottle, for example. Closure moulders especially are stepping up their efforts and investing in dedicated cells to produce high quality and anti-refill closures made up of a number of complex parts.” Due to the intricacy of these closures, moulding precision is paramount.

Significant investment in high quality tooling, automation, machinery, and expertise can be another major deterrent, highlights Ashlee. “Realistically, few counterfeit operators would make the level of investment required to replicate this level of technical precision.”

Other overt packaging methods to deter counterfeits include concealing unique identifiers, such as a QR code, holograms, or tags within the IML.

Another challenge for closure moulders supplying the pharmaceutical and wellbeing sectors is balancing the protection of consumers with usability. As well as child resistance (CR) closures, pharmaceutical companies need to provide for senior friendliness. The result is a significant investment by premium packaging suppliers in sophisticated valve technology to control the dispensing of product, while also preventing containers being refilled.

“Many new and innovative CR packaging concepts utilise complex and sophisticated opening mechanisms, such tamper evident bands on custom closures that requires pressure being applied to two points,” notes Ashlee.

To outsmart quick-witted counterfeiters, manufacturers may consider using several tactics simultaneously to prevent brand value being diluted, including, secure closures, snap buttons, barcoded labels and batch codes, and even chemical markers.

Use of infrared and ultraviolet (UV) light, microscopic tagging, molecular markers, and biological tracers are also being deployed. These technologies can be identified by customs and enforcement agencies using laboratory equipment.

For mainstream packaging moulders producing thin-walled containers, caps and closures by the millions, cost effectiveness nevertheless remains vital. Sumitomo (SHI) Demag’s El-Exis SP range typically achieves between three and five percent more productivity when benchmarked against other packaging machines on the market.

Now in its fourth generation and always aligned to evolving market trends, the EL-Exis SP series is designed to withstand the higher stresses and injection pressures that are so critical in achieving repeatability in complex closures and thin-walled packaging products, while maintaining comparable mechanical properties.

Given the overwhelming popularity of e-commerce, the risks of counterfeiting are more real than ever. “Any steps that brands can do to curb counterfeiting and protect trademarked brand integrity by making packaging harder to replicate or refill will be welcome. The ultimate goal will be to create an unbroken chain of traceability,” ends Ashlee.