The earlier understanding that packaging is not consumed by the end-user, therefore it need not be considered an integral part of the drug, is fast fading off.
The role of packaging in Pharmaceuticals has taken an incremental leap in terms of its critical importance as an integral part of a medicine. The earlier understanding that packaging is not consumed by the end-user, therefore it need not be considered an integral part of the drug, is fast fading off. Many challenges, issues and concerns faced by the global pharmaceutical sector have fuelled this paradigm shift.
The healthy growth in the global pharmaceutical sector has also led to the express desire for having SMART packaging with additional enhanced features, which could fulfill the requirements of an active integrated packaging.
I have my own doubts of attributing this phenomenon to the innovations in drug discovery or NDDS reaching newer heights. My personal viewpoint is that an increased awareness amongst both the producers and the end-users of drugs along with the newer challenges, faced by the pharma industry is the main cause of an enhanced attention towards packaging.
However, I fail to understand why packaging has not yet come under the same regulatory purview, especially for those materials coming in direct contact with the drug products. With longer shelf life being the key objective of the pharma producers for every drug developed and manufactured by them, it necessitates the need for better understanding of the possible adverse impact of the packaging materials remaining in direct contact with the medicines, sometimes for durations as long as 60 months. The adverse impact not having immediate fatalistic implications may also be to an extent responsible for the pharma packaging not getting encompassed under the pharma regulatory ambit leading to the huge gap in GMP where the drug is at one end of stringent regulations and the packaging materials produced for these drugs at the other, with virtually no regulations, except for a few universal guidelines which are merely declared or assumed with super- ficial audits or sometimes even without any audits or inspections.
The better understanding of materials and components through specialised research provided by some leading packaging component manufacturers has resulted in a much higher awareness of the pharmaceutical sector with respect to packaging on a whole and about the critical positive role played by plastics in providing value added packaging components and systems. This is quite evident by the extraordinary growth of plastics in the manufacture of packaging components for pharmaceutical use. The globalisation effect is compelling the pharmaceutical sector in revisiting their existing packaging systems and methods and changing them into better and innovatively packed medications, which are globally compatible and acceptable.
The ever increasing pressure of pharmaceutical sector on the packaging industry to become more novel and effective, is catalysing the change in the R&D thought processes of the packaging industry, propelling it into research and utilising its indepth understanding of material sciences for creating new, innovative products and also orienting its research and development on four key driving forces – Functionality, Time, Price and Global availability.
The pharmaceutical manufacturing operations are governed by a quality code of conduct, the Current Good Manufacturing Practices (cGMP). The cGMP in pharmaceutical operations are further governed by the Drug regulatory agencies of the respective countries, which monitor and enforce stringent guidelines on the pharmaceutical industries for ensuring the quality, efficacy and safety of the drugs being manufactured. Unfortunately, the same code of conduct applicable to the pharmaceutical industry does not get extended to the packaging industry manufacturing these components. There is a need to address these signifi- cant gaps. The most plausible way could be continual yet focused and successfully applicable innovations.
Today, the global pharmaceutical industry faces numerous critical challenges:
• Scientific packaging for providing adequate protection to the drugs for retaining their efficacy and potency throughout their shelf life.
• Abuse/Accidental misuse of drugs
• Counterfeit drugs
• User-friendly packaging systems
• Branding strategy
• Effective management of clinical supplies for global clinical trials
• Speed of clinical trials
• Medication compliance
The pharmaceutical sector has a very strong base in molecule and formulation research, resulting in development of highly effective new drugs for a varied spectrum of dreaded diseases. However, there is absence of same level of expertise with respect to packaging of these developed drugs, which results in grossly inadequate protection against highly varied environmental conditions across the globe, subsequently resulting in huge losses of drugs across the globe due to loss of their efficacy profile over a period of time. This situation is primarily due to inability to understand the optimum packaging requirement for a specific medicine. Secondly, the pharmaceutical sector does not necessarily have the right knowledge of the functional uniqueness/limitations of currently available and used packaging materials as well as their mechanical and chemical properties leading to unscientific and speculative usage. This rather blind way of selection of a specific packaging component results in aberrant observations due to adverse affect of the environmental conditions. Apart from these concerns, the pharma industry is also continually challenged for incorporating innovative solutions on counterfeits, brand differentiation and identity, effective communication to consumers, enhanced compliance and speed-to-market for new drugs.
Counterfeit is one of the most critical challenges faced by pharma industry. Advancements in Information Technology has created another easier avenue for proliferation of counterfeits and spurious drugs. Internet pharmacies are the latest trend for fast and uncontrolled access to almost any drug. The use of conventional packaging along with sophistications in printing technology is making it easier to create a counterfeit. As our Chairman, Mohan Bhandari says, “It has become easier to produce counterfeit drugs than counterfeit currency leading to lesser spend and higher profits.” This underscores the need for packaging industry to be as research oriented as their users in the pharma sector are.
And moreover, the innovations should be viable and application oriented, focused to address the challenges of the pharma sector. This is crucial as challenges of every sector are unique to itself and only a focused approach would churn continual innovations with successful applications capabilities.
Parallelly, the so called pharma packaging industry struggles to meet the expectations of the pharma industry, be it cost, complexities in requirements, small volumes or instantaneous delivery expectations, and hence tends to keep its hands in multiple sectors resulting in commoditising the otherwise scientific packaging requirements. Very few packaging companies in the world are capable of ploughing back some portion of their turnover into research. This creates a vicious cycle of mediocrity in the output of packaging industry, which further results in the produce getting confined to their domestic markets. Also, the research usually gets confined to companies making the raw materials for packaging industry and this research does not have much value addition for the pharmaceutical sector, as its consumption is relatively negligible compared to other sectors.
There is considerable progress being made by companies like Bilcare, focused on providing total value proposition to the global pharmaceutical sector in making packaging evolve from a functional tool to an integrated part of the drug product. This is what leads to the need of research in the field of packaging as such divergent expectations can be only met with innovations. Also, packaging does play the most crucial role in providing the solutions because it is the packaging, which is first seen by the end-user, and which can communicate everything about the drug it holds within itself. There have been quite a few classical examples of success based on packaging in pharmaceuticals. Bilcare has contributed several innovations having successful applications leading to addressing the divergent expectations of the pharma industry. The need is to create a focused approach towards development of packaging solutions exclusively for pharma products.
A few new technologies have been researched and developed but have not really been successfully adopted by the pharma industry. The prime reason may be because the Pharma industry is looking at conventional ways of cost cutting and not at total effective costing. Pharma Industry becomes more satisfied on the cost per kg concept without realising that they are losing more on an overall basis. Other area is the development of technology, which would identify the optimum packaging system on an enhanced speed to enable avoidance of multiple studies during the stability programs. Bilcare, for instance, was successful in developing a novel patented technology during its past 10 years of research, which has the capability to identify the sensitivity of any formulation using a 30-day evaluation program and establish scientifically, the most suitable and optimum packaging system for that product based on several key packaging dependent parameters. Such unique technologies imply immense value proposition to the global healthcare and life science industry to ensure complete integration of the packaging system to the drug product it encases and also the viability of total effective costing model.
Partnering has been found to be the most effective alternative to integrate innovations on both sides. Partnering research initiatives is increasingly gaining momentum to address the current and future key concerns, be it speed-to-market, counterfeits, enhanced stability of the product coupled with increased shelf life, brand differentiation and identity, enhanced compliance, comprehensive support for global clinical trials or packaging innovations.
Focused, research-based companies like Bilcare have taken significant strides to partner with the global pharmaceutical sector in addressing the crucial limitations and concerns through research pathway churning continual value-added innovations in the form of products and services.
Praful R Naik, Chief Scientific Officer, Bilcare Limited, India
