Recently, you delivered a lecture at WPO Budapest 2016 a lecture on innovations in pharmaceutical packaging. Tell us more about it.
It was a proud moment to speak at the international conference at Budapest. Learned delegates from more than fifty countries across the globe participated. I addressed the topic ‘Innovations in pharma packaging under the backdrop, Changing World’. Right packaging need be designed around the drug to improve patient compliance, defeat counterfeiting, engage patients, and at the same time create brand awareness. Packaging innovation has a large role to play in the highly regulated pharma market. Whether it is to improve pack protection, deliver convenience and ease of delivery or encourage patient compliance, packaging’s role cannot be underestimated.
The biggest challenge in healthcare is to ensure that the package contributes to the overall effectiveness of the treatment over its intended period. Patient adherence should be a primary goal, assuming that the patient is capable of taking medicines independently. Today, studies show that patients start off adhering to their prescriptions but this adherence can fall off over time. Sometimes, this problem can be due to the drug-delivery design, or the taste of the formulation. However, packaging can be a strong factor in getting patients to take their medicines. In the end, the final point of contact between the patient and the healthcare providers and/or the distributors of medicine is not the dispensing pharmacist, but the pharma package. If the packaging is difficult to open or use, or features confusing instructions, patient adherence is placed at risk.
How will sustainable innovation in pharma packaging help the industry to grow?
Well, there have been several innovations put into commercial use that are here to stay for longer periods. Even on the material front, to ensure the moisture barrier and arrest migration, advanced aqueous-based coatings are going to replace the film laminations onto paper and paper boards. Smart packaging is one of the sustainable innovations in the pharma sector. Smart packaging goes beyond the use of simple packaging materials combined with traditional printed features of graphics and barcodes. It is a packaging system that is capable of carrying out intelligent functions (such as detecting, sensing, recording, tracing, communicating, and applying scientific logic) to facilitate decision making to extend shelf life, enhance safety, improve quality, provide information, and warn about possible problems. The importance of eco-friendly and sustainable packaging also never diminishes as environmental concerns are also on the rise. For example, some companies are already working to reduce their carbon footprint by increasing the use of recycled packaging materials and reducing the amount of virgin materials used in packaging. Usage of biodegradable material in their packaging can be found more in cosmeceuticals and the healthcare sector.
What are the key pharma packaging trends which were discussed during the conference? How will it impact Indian pharma packaging?
Various topics were touched upon at the conference. Now, everyone realises that packaging no longer means just to contain the product with nice graphic designs, and a show of hues and printing techniques! Future packaging innovations will go beyond the visual appearance of the packaging, beyond the structural characteristics and the material specifications. They will be more interactive and serve as multi-utility products. The new trends in packaging, in general, would be sustainable packaging. Waste to value propositions will get more clarity and harmonisation. Interactive and intelligent packaging will become more real and get commercialised. There will be growth of sale due to packaging-enabled innovation. As far as pharma packaging is concerned, there will be more and more compliance packs in the market. Patient adherence will be given equal importance. The Indian pharma packaging industry has already realised the market demands and regulatory requirements. It is rapidly trying to keep pace to stay in the race.
The Indian government has mandated track and trace on primary packaging for pharma exports. What are your views on this move?
The pharma industry continues to advance towards a state of flawless track and trace compliance worldwide, obviously India cannot afford to lag behind. Serialisation, track and trace were once considered as value additions to the product. It’s no longer the same scenario now as they have become mandatory, especially in the pharma industry.
Sometimes the process of implementation may be complex and rather confusing, considering different directives from regulators across the globe.
What’s your take on the US Consumer Commission petitioning to the US Department of Justice to take action against DRL?
While I do not want comment on this specific instance, it only underlines how critical and important it is to comply with legislations. In the regulated markets, especially the US, there is a requirement for child-resistant packs, both for unit-dose and multi-dose packs. The packaging must be child-resistant and at the same time senior-friendly. According to the US Poison Prevention Packaging Act (PPPA), the term ‘child-resistant’ means that the ‘packaging is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly.’
Why are pharma companies finding it challenging to adhere to child-resistant packaging? Which are the available competitive solutions?
Developing child-resistant packs is always a challenge as it has to comply to CPSC requirements. The pack needs to be evaluated by an authorised testing agency for compliance. Subsequent variation, if any, in the container closure system or the design of opening mechanism needs to be evaluated before introducing into market. Designing of the blister pack as well as the forming and sealing materials shall be decided based on toxicity value (‘F’ value) of the molecule. Every manufacturer needs to generate a ‘general certificate of conformance’ stating the child resistant (CR) testing details for each batch of the product to be marketed in the US. Maintaining the balance on compliance to child resistance while facilitating easy access to elderly people is always an uphill task.
With demand for these packs are on the rise, there have been various new innovative developments in this arena. The world’s first reclosable child resistant carton, the Locked4Kids is the new kid on the block. Burgopac’s slide CR pack, Medlock Ez system, Amcor’s AOF featured child resistant blister lidding are a few other examples. The child resistant closures for jars and bottles have been in existence though with limitations, for quite some time.
What is the future of the Indian pharma packaging industry?
India exports several APIs and dosage forms to almost all countries in the globe, be it the developed countries or the developing ones. Since these products deal with the health of the people, each country takes utmost care in importing these medicines and in assessing their quality, genuineness and source. Hence, each importing country has stringent regulatory requirements for import of medicines and they are unique to each country. There is a requirement for exclusive packaging and labelling in all the cases. Indian pharma industry has a big boost with the just announced government decision that clears any hurdle of FDIs into this sector. With this new ruling, 74 per cent of foreign direct investment has become possible. These factors will drive growth in the pharma packaging industry. Influence of regulations, increasing needs of customers and the medical practices, rise in requirements of tamper-evident, child-resistant and senior-friendly packaging will lead to the evolution of new packaging technologies. Pharma packaging industry in India obviously will grow along with the core industry.