Bilcare is recognized as Asia's leading producer of primary packaging materials and systems for pharmaceutical solid dosage forms. Pursuing its strategy to be a global provider of clinical supplies management services, Bilcare has established multiple facilities in India and Singapore besides setting up one in USA through acquisition supplies Asia for clinical trial services. With an added emphasis on research and innovation, the Pune-based company is currently catering to over 500 customers worldover. Excerpts from an interview with Dr Praful R Naik, executive director, Bilcare
Packaging has become a very important part of pharma companies as the innovation in drugs and the novel drug delivery system reach new heights. Your view on this
Packaging is gaining the attention of the pharma sector as one of the equally important inputs as compared to the drug or the excipients themselves. The earlier understanding that since the packaging is not consumed by the end-user it need not be considered an integral part of the drug is fast fading. Many challenges, issues and concerns faced by the global pharmaceutical sector have fueled the paradigm shift. I doubt if we could attribute this phenomenon to the innovations in drug discovery or NDDS reaching newer heights. An increased awareness amongst both the producers and the end-users of drugs along with the newer challenges the pharma industry is facing is the main cause of an enhanced attention towards packaging. I wonder why packaging should not come under the same regulatory purview as that of the pharma sector, especially for those materials coming in direct contact with the drug products. With long shelf life's being the key objective of the pharma producers for every drug developed and manufactured by them, it is very important to understand 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 leading to the huge gap in GMP where the drug is on one end of stringent regulations and the packaging for these drugs is on the other end with virtually no regulations, except for few universal guidelines which has to be only declared without the need of audits or inspections.
Pharma companies are increasingly looking at cost cutting and enhancement of shelf life of a product. How can packaging play a pivotal role in providing solutions to these issues?
That is what leads to the need of research. Such divergent expectations can be only met with innovations. 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 therefore it is packaging which can communicate everything about the drug it holds within itself. There have been quite a few classical examples of success based on packaging even in pharmaceuticals. Bilcare has contributed several innovations having successful applications leading to addressing the divergent expectations of the pharma industry. So have other global companies. The need is to create focused approach towards development of packaging solutions exclusively for pharma products.
Pharma industry has been facing serious counterfeit problems. What steps packaging industry should take to tackle this problem?
Pharma industry is indeed going through a turbulent phase besieged by significant increase in counterfeits. Advancements in information technology have created yet one easier avenue for proliferation of counterfeits, duplicates and spurious drugs. Internet pharmacy is the latest trend for fast and un-controlled access to almost any drug. The use of conventional packaging along with sophistications in printing technology is making it easier to create a counterfeit. It has become easier to produce counterfeit drugs than counterfeit currency leading to lesser spent and higher profits. The packaging industry needs to be equally research oriented as their users, the pharma sector. And the innovations should be focused to address the challenges of the pharma sector. A packaging industry cannot be into all sectors and come out with a viable application oriented innovation for the pharma sector. Challenges of every sector are unique to itself and only a focused approach would churn continual innovations with successful applications capabilities.
What is the current status of the Indian pharma packaging industry? (in terms of turnover, various segments, major companies, etc)
Truly speaking there is no concrete industrial segment which can be called the "Indian pharma packaging industry". Most of the packaging companies cater to a host of sectors and pharma is one of them by default. It would not be a true representation if we were to take the turnover of all packaging companies and call it the Indian pharma packaging turnover. I dare to say this because there are packaging manufacturers and suppliers who do not even know the basics of cGMP for pharmaceuticals and are still supplying packaging materials to the Indian pharmaceutical sector, that too primary packaging materials, which essentially comes in direct contact and remains so with the drug product packaged within it till it is consumed by the patient. These suppliers claim to be pharma packaging companies even when they produce and extensively market non-pharma grade packaging materials and products to several diverse industrial and consumer sectors. Regarding the key segments for pharma packaging industry we could break it into 2 segments i.e. primary packaging materials which come in direct contact with the pharmaceuticals substances and the secondary packaging materials which do not come in direct contact with the drugs and include the tertiary and subsequent packaging components as well. The primary packaging materials can further be dived into 3 key segments: Blister, pouch and strip packaging materials for solid dosage forms, container systems (both plastics and glass) for solids, liquids and parenteral products and tube systems for ointments and gels. The secondary packaging material includes the outer packaging which essentially contains the pharmaceutical product packaged in the primary packaging systems. These can include cartons, labels, shippers, promotional / instructional materials. Printing industry also plays an important role in supplies of printed primary packaging materials (aluminum lid foils, aluminum strip foils, composite laminates) and printed secondary packaging materials.
What are the various types of packaging methods (technology) used for pharmaceutical products?
For solid dosage pharmaceuticals, blister packaging is widely used packaging technology in India. Cold form blisters have gained popularity as blister technology in the recent past. Many of the natural medicines i.e. ayurvedic products are still bulk packaged in containers predominantly plastic but also some glass. Blisters are slowly gaining popularity in this segment as well. For liquids, mostly glass bottles are used. However, PET bottles have also gained acceptance for packaging of certain liquid products. Parenterals, SVP are packaged aseptically in glass with tubular glass vials gaining more popularity and the LVPs have seen the plastics taking over glass with the blow fill seal technology providing the capability of the use of plastics for packaging of LVPs. The same technology is also now being used for SVP's which can see increase in its popularity in near future. Lami tubes rule the market for ointments/gelsmaking aluminum tubes almost obsolete except in a few product ranges which still use aluminum tubes. Packaging equipment manufacturers have been keeping their strides with the pharmaceutical sectors dynamic needs and have been able to cater to their specific requirements in terms of greater flexibility, tooling etc.
However, newer packaging concepts have not yet seen their way into the Indian drug market possibly due to the fact that over here the drugs are dispensed by a pharmacy and are more prescription oriented.