Innovation comes from provoking the industry to think differently

In an interview, Steve Duckworth, Head of Global Segment Healthcare Polymer Solutions, Clariant and Yann Ischi, Director of New Channels and Partnership at SICPA with Chemical Today Magazine jointly talk about the grave risk thatpharmaceutical counterfeiting poses on the world by potentially risking the health of millions of patients. They also open up about the innovations that Clariant and SICPA are working on to curb this menace.

By Debarati Das

Global trends related to counterfeiting in medical and pharmaceutical applications.

According to a recent report by MarketsandMarkets, the global medical devices market is expected to record a CAGR of 6.5 percent (from $61 billion in 2014 to $89 billion) from 2014 to 2020. However, this strong growth has also attracted counterfeiters who are often part of organised crime syndicates producing fakes, which are often very difficult to differentiate from legitimate products, often escaping customs inspections.

The World Health Organisation states that more than 8 percent of the medical devices in circulation are counterfeit, and Interpol estimates $75 billion in counterfeit pharmaceuticals enter the market every year. Clearly, counterfeit medical devices pose a significant liability to their manufacturers and a risk of injury, permanent disability, or even death to both patients and healthcare providers. The mission of safe access to treatments remains a challenge to medical devices and pharmaceutical companies despite investments in fighting fakes.

India and China will be the fastest-growing markets due to rapidly expanding pharmaceutical manufacturing capabilities and the adoption of more stringent regulations aimed at improving the quality and integrity of domestically produced pharmaceuticals.

Organisations are now positioned to capture rapid urbanisation and growing consumer demand. An ageing population in developed economies and a rising middle class in developing economies will drive demand for pharma innovation in the foreseeable future. This, in turn, will drive growth in pharmaceutical packaging and plastic medical devices.

Thus, the pharma companies need to be careful in fighting counterfeiting in this rapidly growing industry

Development in colour, performance materials for medical and pharmaceutical applications.

The clear trend for all materials for use in pharma packaging is to meet the tougher requirements for regulatory compliance and emphasis on change control. This needs 'innovation' in new services as well as new products.  An example is a recent change in the USP <661.1> in June 2016 for packaging materials, which bring new test methods for extractable metals.

This poses a challenge to pharma companies to find materials, which are compliant.  The Remafin-EP white and MEVOPUR range from Clariant support this. For example, all REMAFIN-EP products are available with USP <661.1> declarations.

When it comes to product innovation, brand managers of pharma companies often look to differentiate OTC (Over The Counter) products, by using more attractive packaging. However, these packaging materials also need to meet the relevant pharma regulations. 

We have taken our vast experience in special effect colours for personal care/cosmetics packaging market and introduced MEVOPUR ‘special effect colours’ in compounds and masterbatches that offer the same USP <87>, <88> and ISO 10993 declarations as the rest of the MEVOPUR range.

Innovation comes not just from recognising needs at an early stage, but also provoking the industry to think differently. ‘Blue metallic’ for bottle closures? Why not!

Tackling pharma counterfeiting in India, through innovation in packaging

Pharmaceutical counterfeiting is on the rise around the globe, potentially putting at risk the health of millions of patients who take for granted that the prescription medicines they buy are safe and effective.

Counterfeit drugs are dangerous by their very nature as they are not produced under safe manufacturing conditions and they are not inspected by regulatory authorities.

According to the report on Anti-Counterfeiting packaging market by MarketsandMarkets, the anti-counterfeiting packaging is a growing market and is forecast to reach $128.6 billion by 2019.

In fact, Asia-Pacific is the fastest growing market for anti-counterfeit technologies where there is increasing awareness about counterfeit products all-pervading the region.

Packaging plays a crucial role in preventing the counterfeiting of sensitive and vulnerable products.

With Clariant’s collaboration with SICPA, we have come up with a new plastic-based anti-counterfeiting system PlastiwardTM for plastic pharmaceutical packaging as well as medical devices.

Developed in partnership with secured identification, traceability and authentication solutions and services provider SICPA, PlastiwardTM is designed to deliver security assessment, definition of needs, security system design, system deployment and on-going performance monitoring.

This technology was introduced in India at CPhI 2016 in Mumbai. We look forward to working with the pharma industry in India.

Product showcase at CPhI India 2016

The products showcased by Clariant Polymer Solutions at CPhI were:

MevopurTM LQ: Mevopur LQ is an advanced liquid colour and additive concentrate used for transparent pharmaceutical packaging

MevopurTM LQ – trans amber: This product has been designed to support the US Pharmacopeia requirement under USP<661> ‘Plastic Packaging Systems and Their Materials of Construction’.

Remafin EP: Clariant’s Remafin-EP range of whites combined with the MEVOPUR colours are used in production of pharmaceutical containers and closures for parenteral, ocular, and nasal drugs – a growing category in India

PLASTIWARDTM:  Clariant and security experts SICPA cooperate to offer PLASTIWARD in-plastics security system to fight the rise of fight the rise of counterfeit medicines effectively protecting devices and packaging from counterfeiting. 

Clariant’s collaboration with SICPA

Counterfeiting of medical devices and pharmaceuticals has been termed as one of the biggest plagues of the industry. Clariant’s collaboration with SICPA is primarily to solve this counterfeiting problem.

This collaboration is a noteworthy one as it combines two organisations who are specialists in their field – Clariant’s record in developing polymer compounds and masterbatches coupled with SICPA’s expertise in providing security solutions, to offer the best solution for pharma companies worldwide.

The collaboration will give birth to the enhanced and more secure packaging of medical devices and pharmaceuticals through a technologically advanced solution, PLASTIWARD™.

This in - plastic system offers a unique end-to-end solution integrating exclusive, proprietary security features from SICPA into polymer compounds or concentrates (known as “masterbatches”) from Clariant. PLASTIWARD™, besides being a packaging component, also forms part of a system that enables real-time monitoring of global, regional or local levels through the data uploaded on an SICPA platform.

This provides pharmaceutical companies to actively track their products when in motion, i.e. from the factory to the destination.

At Clariant, our 3C approach (Controlled, Consistent, Compliant) with our MEVOPUR ® products for the medical and pharmaceutical sectors is based on helping to control and minimise risks of potential changes and regulatory non-compliance- supply chain.

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