The proof is in the pack
Get to know the packaging trends that are making rounds in the pharmaceutical industry.
BY TEAM MT
How comfortable would you be taking a pill out of a box rather than its packet? Products manufactured to resolve health problems would not be of any use if they are not packaged properly. Interestingly, the fast growing domestic market has led to the Indian pharma packaging industry witnessing double digit growth rates. New markets for specialty medicines, biopharmaceuticals and biosimilars are opening up, entailing opportunities for further growth. The coming years will see even stronger differences between the various pharmaceutical branches and markets. While generic producers and contract manufacturers still require very robust and easy-to-operate machinery with high output, the development of new medicines for targeted treatment demands flexible platforms and smaller batch sizes.
Agreeing Andreas Mattern, business unit head, pharma India, Bosch Packaging Technology said, “For most Indian companies, robust and powerful machines remain the first choice. Especially generic producers who want to achieve the highest possible productivity at lowest possible costs. Since many global drug manufacturers have shifted their focus to the development of new formulations, they have outsourced their filling and closing operations, as well as secondary packaging to contract manufacturers, amongst others in India. The latter’s main concerns are flexibility and productivity – primary and secondary packaging machines must be adaptable to different products, packaging formats and speeds at consistently high output rates.”
SV Krishna Prasad, CEO & director, Cito Healthcare mentioned that the Indian fascination for rigid packaging remains intact. “It is estimated that more than 80% of the total packaging in India constitutes of rigid packaging, which is the oldest and the most conventional form. The remaining 20% comprises of flexible packaging.” However, with the expanding middle class and rising income levels, the patterns of consumption are bound to change substantially and the demand for quality and convenience-based products will increase.
However, with plastic being used as a substrate in flexible packaging there are pressures on using it due to environmental reasons and safe disposal. These issues act as a major impediment in flexible packaging becoming an all-pervasive medium. Since, paper and paperboard are environment-friendly they enjoy the advantages of easy handling and efficient process implementation.
While there are good things in store, the threat that constantly engulfs major brands is the counterfeit menace. “According to WHO and various other research agencies every fifth drug manufactured in India is counterfeit. This has led pharma companies to partner with primary packaging players globally to fight the nuisance. Few security measures adopted by packaging companies include holograms, UV and three dimensional effect, multi colour tonal designs, water marks through various techniques, RFID, a unique number being assigned to individual packs, ink and print technology, etc. Also, increase in potentially harmful drugs has forced pharma companies to introduce child resistant packaging solutions,” averred Ashis Bhattacharya, MD, Essdee.
Mattern stated that India is mostly concerned with the serialisation of export products, which should have 2D or 1D data matrix code on their secondary and tertiary level packaging with the following information: global trade item number (GTIN), batch code, expiry date, serial number. “This is crucial to comply with upcoming serialisation requirements, for instance in the European Union or in the US. Both the European Union’s Directive 2011/62/EU (Falsified Medicines Directive) and the American Drug Quality and Security Act (DQSA) stipulate the implementation of uniquely coded, serialised packs for almost all prescription drugs.” At the same time, the EU demands a second layer of security – tamper-proof closures, which clearly indicate whether a package has been previously opened or tampered with.
Mattern suggested how pharmaceutical manufacturers can establish new procedures for the management and storage of serial numbers, which in turn requires the adaptation of their packaging processes. “A track and trace system should not only be able to mass-serialise the packed product in the sense of printing a code onto each pack but these codes also need to be verified unambiguously. Moreover, the packs are usually equipped with a label or integrity seal, before the next packaging layer is added. The entire process needs to be controlled and the data retrieved at any time. Only this way do producers – and later on the issuing authorities and legislators – have an exact overview of all process steps. This calls for a sophisticated software architecture, which is able to integrate the serial numbers consistently on all levels – from devices, line processes and line management to production and enterprise control.”
According to the Indian Packaging Institute, the Indian packaging industry is USD 14 billion and growing at more than 15% p.a. These figures indicate towards a change in the industrial and consumer set up. In such a scenario there are bound to be certain trends that are or will turn out to be big gainers to the industry. One of them is child resistance (CR) packaging, which is a growing development considering that of late regulators are stressing more on CR and user friendly packaging models. Explaining the concept, Prasad said, “CR packaging is essentially designed to prevent children from accessing pharmaceutical and other potentially harmful products. It is used to reduce the risk of children ingesting dangerous items, for example, by placing a special safety cap.”
There are elderly resistant packages too. Though it is felt that elders are at par with children when it comes to many routines and certainly as well in packaging requirements of the products/drugs they use, the package closures which require two dissimilar motions for opening, could be less easy for elders and required to be simpler. “The regulations for this are based on protocols of performance tests of packages with actual children, to determine if the packages can be opened. More recently, additional package testing is used to determine if aged individuals or people with disabilities have the ability to open the same packages,” Prasad informed.
Recent reports mention that the incidence of Alzheimer’s and other age related disorders are going to be a major cause of worry in the near future. By 2020, it is said that 14.2% of above 60 age population will be in India only. In such a scenario, packaging has to be worked out in a way that will provide patient compliance with its own ease.
“This is true. Strategic approaches to improving treatment compliance will have to include simplifying treatment regimens, using reminder or electronic enabled packaging, utilising multi-panel designs that identifies dosing or specific instructions, if any, employing a calendarised pack and developing more patient or caregiver-friendly modes of administration. Also, developments in alternative modes of drug delivery, such as transdermal patches, may offer effective, well-tolerated treatment options with the potential to enhance compliance. In addition, a lot of work is being done in this area to develop a more ‘talkative’ pack to further ensure compliance,” mentioned Bhattacharya.
Currently, India is a major player in global formulation’s market and sees different types of primary packaging structures. Some of these include bottles, ampules/vials, aluminium strip and blister foil, cold form blister, suppository packs, etc. “Blister packaging has seen fastest growth in Over the Counter (OTC) segment where packaging is also used as a brand promotion feature. With OTC poised to outpace the pharma sector and pharma companies giving preference to blister packaging, we believe that there will be double digit growth in this segment,” opined Bhattacharya.
Mattern believes that India already is a global leader in the generic drug market and will experience further areas of growth in contract manufacturing and hosting clinical trials. “Pharmaceutical exports from India are forecasted to increase more than two fold over the next four years, if India succeeds in meeting regulatory challenges. Many companies have already invested or are planning to invest in more sophisticated machinery to meet the ever complex requirements and therefore the market looks like it is only going to grow in the coming years.”