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Pharmaceutical packaging involves complex processes and products. The key purpose of which is to conserve the drugs for effective end use, as well as sharing of the product information to consumer and medical practitioners. The very fact that pharma products are deemed necessity for life, the robustness of the package decides its’ integrity. However, robustness may impart an element of excessive material usage, thus leading to generation and accumulation of waste across the value chain of pharmaceuticals. One of most convincing solutions for the problem of waste generation is imbibing concepts of ‘circularity’ for the pharma packaging.
The use of packing and packaging materials have increased considerable over past years. This over-use has resulted in quantum growth in the packaging waste and challenges in its management. Similar to other packaging materials, the pharmaceutical packaging materials are also disposable. The materials and investments are lost if it cannot be considered for recycling. Therefore, packaging is one of the important segments of the value chain, where circularity analysis is of paramount importance. In general, packaging is an area where considerable modification of the existing practices can be undertaken on priority. In Europe, industry and regulatory agencies have established a creative-connect to work in synergy for circularity of the packaging and have set ambitious targets. The goals include a three-pronged approach, namely, reduction in packaging and its waste, enhanced usage of reusable designs and overall reduction in the deployment of complex packaging materials. Inclusion of life-cycle assessment at the design stage of the packaging helps to produce wanted packs. Although very important (and most talked about), the circularity is still far from reality in the developed as well as developing countries. Since, the pharmaceutical industry is bound by regulatory norms and therefore has to pass several intricate inertias to change the packaging formats. Hence, it is essential for the governments and pharma regulatory authorities to consider adoption of the new mantra of circularity in the pharma sector.
There is a need for a universal definition of ‘circularity &/or circular economy’ for harmonisation. A commonly accepted definition of circular economy is –“Circular Economy is an economic system wherein products and materials are used in a way, which maintains the value in a material cycle as long as possible, while energy is used efficiently and the waste is either recycles or avoided”.
Significant environmental benefits
Research carried our worldwide shows that, a well-crafted packaging can result into significant environmental benefits. This is due to the fact that, losses along the value chain minimise due to such as approach. Furthermore, the environmental benefits sought from recycling of packaging, prove to be of higher magnitude than energy recovery. The environmental factors mostly depend on the materials used for the packaging. Most of it are complex substances. This makes it difficult to recycle. Since, the recycling systems for pharma packaging are in nascent stage, it realises the problem statement more difficult to tackle.
On account of bio-hazard contamination, the plastics used for healthcare may require sorting process, before it is recycled. The paper boards, metallic sheets of aluminium and glass are well managed in the respective recovery streams. Although innovations are possible at multiple level, the challenge will be treatment of bio-hazardous packs before the packaging materials are considered for recycle and reuse process.
Vital touch points
The value chain management is one of the most important parts of the circularity in the pharmaceutical packaging. Range of activities, that are required to bring the product to reality in the marketplace, constitute vital touch points in the circularity. Production, logistics, transforming inputs and needful accessories determine reasons for hotspot creation during the life cycle of the pharmaceutical packaging. The circularity shall also encompass the product’s journey till it finally delivered and consumed. As a matter of fact, at this juncture several factors about materials and methods across the pharmaceutical value chains are unknown. Hence, it is essential for industry incumbents to undertake a thorough and deep analysis of the entire value chain. It is essential to identify key value chain activities to gain insights into possibilities of seeking circularity.
Regulations govern the implementation of circularity in the pharma sector. European regulations specifically deal with pharmaceutical packaging related aspects. EudraLex is a compilation of rules and legislations governing medicinal products in the European Union. EudraLex generally presents regulations for the marketing authorisation, including the packaging information of medicinal products and categorisation of supply, package leaflet and label requirements. Volume 2C and 6C of the regulations deal with the presentation of the medicinal product covering pack size, design and composition. The guidelines emphasise that, while presenting the different pack sizes of the drug products, it is important to rationalise the usage. The sole purpose of these guidelines is to describe how the directive 2001/83/EC and regulation (EU) 2019/6 were implemented in the case of a marketing authorisation. As per the regulatory norms, the party seeking marketing authorisation, must apply for the separate approvals, once they change the packaging type to a sustainable option. The integrity of the drug and the formulations being the most important criteria during the approval process.
Guidance on packaging
The World Health Organization (WHO) has published guidance on the packaging for the pharma products. WHO expresses concerns on the environmental impact of the packaging, however it emphasises the fundamental criteria on protection of integrity and quality of the medicines dispensed in various kinds of formulations. WHO further stresses upon the need to lower the weight of packaging materials, keeping its barrier properties intact. Furthermore, WHO appeals the industry and packaging material suppliers to innovate the application of environmentally friendly materials as a part of packaging. It is also stressed upon that packaging materials that are in direct contact with the toxic drug substances, should be incinerated and rest of the package may be evaluated for recycling.
The whole of value chain presents possibilities for implementation of circularity. While the manufacturers are being challenged to gain circularity, economic support should be made available for experimentation. Also, government authorities must permit testing and piloting. Packaging design guidelines should be aligned with the perspectives of circularity. Use of mono materials in the packaging should be encouraged in order to enhance circularity. The formulations can be chosen in such a manner that, it requires less intensive packaging, for example, film coated tablets. The efficiency of the transport systems of pharmaceuticals should improve and life cycle analysis-based knowledge is needed to help the distributors, dealers and retailers in recycling the packaging. The efficiency of the transport system of pharma products must be improved to catalyse circularity. Dose distribution can be developed to use the larger packs, which can further reduce blister quantity. Roping in general pharmacies and hospitals in the circularity chain is also necessary. A thorough consumer research needs to be carried out for ascertaining how much of the medications are left unused and the reasons behind the same. These aspects will give more impetus on circularity and a genuine need for reduce-recycle.
Thus, the environmentally advantageous pharma packaging is a world of new opportunities. It not only opens a blue ocean of business opportunities for the related stakeholders, but also poses newer regulatory challenges. It is imperative to explore new materials on the regulatory criteria for container-content compatibility. Various regulatory aspects to be ascertained before green materials are suggested for the pharmaceutical packaging considerations.
(The author is founder, Chemistry Innovations)
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