As the pharma industry continues to evolve and faces unprecedented challenges and opportunities, players in the pharma packaging sector too need to up their game with strategic investments in R&D
The Indian pharma industry is expected to grow to $55 billion by 2020, courtesy ageing and growing population, rising income levels, emergent medical conditions and diseases etc. However, growth in the pharma packaging industry is unable to meet the same pace. To accelerate progress in this sector, which is expected to be worth $2.60 billion by 2020, there is an urgent need for innovation which in turn needs substantial investment on R&D.
So, what are the aspects which highlight the need for a renewed R&D focus in the pharma packaging industry?
The current focus on packaging R&D is in the areas of product safety, stability and patient’s compliance. As Jaya Abraham, VP, Research and Development, Alvogen highlights, “R&D in pharma packaging would have a significant impact as India’s growing population and economy is creating a large middle class with the resources to afford differentiated medicines to improve the overall treatment outcome.”
Moreover, the looming threat of counterfeiting has also opened up new opportunities in this segment. Industry reports too validate this fact. According to markets and markets research report, stringent government regulations related to manufacturing of counterfeit medicines in several countries of the world has given the opportunity to increase the investment in R&D and be the growth driver of the pharma packaging market during the forecast period, 2016 to 2021.
Mohan G Joshi, International Business Coach and Former President, SCHOTT Glass India informs, “10 to 30 per cent pharma drugs under circulation globally are counterfeit and are responsible for up to one million deaths due to ineffective drugs. The packaging industry need to address challenges faced by pharma companies which are in the areas of counterfeiting, theft, diversion and false returns to manufacturers.”
He continues, “One clear objective of R&D growth should be driven by the demand for counterfeit technologies which include barcodes, tamper evident packaging and more recently, radio frequency identification (RFID). These security devices provide no assurance for the authenticity of the contents and alone do not eliminate counterfeits but act as strong deterrents due to ease of identification.”
Rishad Dadachanji, Director, SCHOTT KAISHA says that highly sensitive formulations require packaging which minimises drug/ container interaction over the shelf life of the product, combination products can be filled in double-chamber systems, unique tamper evident closure can be used as a step in anti-counterfeiting and the fight against spurious drugs. These solutions provide advantages such as shelf life stability, easy administration of combination products, a unique product identity and enables a pharma company to gain credibility and confidence from doctors and the end consumer.
Challenges to overcome
Yet, despite the manifold benefits, there are several factors hampering investments in this sphere. Joshi highlights, “It really starts with India’s low investments in scientific research. Pharma packaging companies are part of a large value chain of pharma companies. The education system is to blame as well as we still have focus on imparting theoretical knowledge and not focusing on problem solving and innovation. Any research investment must focus on four pillars: finances, infrastructure, human resources and legal & regulatory framework.”
According to Prabir Das, Head – Packaging Services, OSD (India), Mylan Laboratories, lack of a designated team in R&D of packaging has also lead to sluggish growth in the pharma packaging industry. He says, “Only few big players forming the upper layer of the industry have designated packaging teams at their R&D centres. For an overall growth and development of the industry, every organisation needs packaging specialists to keep themselves floating in today’s competitive market.” He further asserts, “It is important for people to understand that packaging is as important as the product, then the challenges can be easily addressed. A majority of the packaging industry is still being considered and controlled under unorganised sector and there are gaps between requirements – understandings – deliverables – compliance.”
Steps to progress
However, the industry is waking up to R&Ds growth potential in the pharma packaging sector. Yet, there are several factors to be considered while embarking on this journey. As Dadachanji highlights, “It is no longer enough for suppliers to focus on their core areas. They are rather required to take the entire value chain into account.”
He further informs, “To boost investment in R&D in this sector, pharma packaging companies must understand the changing trends and new requirements demanded by the end users. This knowledge and understanding gives us the foresight to be able to develop what the market needs and ready to offer it when the market needs it. We, as a packaging firm, are constantly in touch with our partners and by understanding their needs and the needs of the consumer, we are able to invest in new R&D activities. Continuously strengthening this chain of open communication is an important driver which helps us constantly increase our investments. Constant innovations in the pharma industry itself has a direct impact on the primary packaging which plays an important role in helping bringing these innovations to the markets. New drugs which require unique and stable packaging rely on innovations in the packaging sector as ‘the medication is only as good as the container it’s in. Schott Kaisha took the initiative and invested into R&D activities and works closely with partners in order to be able to supply our customers with an entire basket of products and innovative new technologies.”
Abraham says, “Indian companies have started entering into the realm of R&D with few NCE (New Chemical Entities) and new biologicals and differentiated formulations and innovative packaging solutions like the Starhaler from Sun Pharma; India has the world’s second biggest pool of English speakers and a strong system of higher education like the IITs and IIP, so it is well-positioned to serve as a source for research talent. To be a part of the change, packaging R&D team compositions would need scientists from diversified backgrounds and will be key to success.”
Outlining a strategy for packaging R&D, Joshi says, “The first stage focus must be to implement serialisation at multiple packaging levels. The next phase is to implement an electronic pedigree, where companies can show data across the supply chain. Track and trace technology plays a crucial role for any pharma supply chain. The aim of pharma industry is to prevent the illegal and dangerous counterfeit medicines to reach the end consumer and track and trace research is the major tool to help easy identification of products throughout the supply chain.”
Joshi believes that investments in R&D for pharma packaging are strongly dependent between collaborations with pharma companies and/or between major players in the supply chain. He pointed out to the recent collaboration of Corning and Gerresheimer which has announced a glass innovation aimed at enhancing quality of parenteral packaging. Corning Valor Glass is a breakthrough glass container engineered for the storage and delivery of 21st century injectable drugs. Valor Glass’s superior strength, chemical durability and damage resistance result just not in better protection of drugs but also enables increased throughput and higher quality assurance for pharma companies and patients.
According to Das, awareness building and understanding the importance of investment in R&D are the two major factors to change mindset of promoters and investors. There are many awareness programmes being organised to make people understand its importance to protect and preserve the quality of the products, safety and security through supply chain and to survive and sustain in the market as a brand.
Success with R&D
As the packaging industry wakes up to the need for R&D in packaging, companies are slowly and steadily investing in it to provide new and innovative solutions that can drive growth.
GIving an instance, Joshi highlights that SCHOTT Glass has invested heavily in research and development for Type 1 plus vials. Increasing shelf life stability for sensitive drug formulations is a challenge for all companies. Protein adsorption and leaching from primary packaging are known to be root causes of reduced shelf life in sensitive formulations. SCHOTT Type I plus vials have an inside SiO2 coating with outstanding barrier properties. This reduces the interaction between drug formulation and container surface to a bare minimum, thereby providing a superior packaging solution for sensitive ingredients.
He gives another example and says, “Indian global company ACG Worldwide is a one-stop-shop offering integrated manufacturing, packaging and R&D solutions to the global pharma industry. ACG Worldwide has synergistically integrated business right from granulation and coating equipment to hard capsules and capsule filling machines. So long term commitments and establishing partnerships for mutual benefit is a prerequisite for increasing investments in R&D of pharma packaging.”
Path to progress
The continuation of support received from government with strategies such as the Make in India initiative has motivated the industry to supply high quality products which meet international standards. But, to increase investment in R&D for packaging, the industry expects some kind of financial help and tax benefits to ensure strong infrastructure, backward integration, smooth and fast communication and better distribution channels. Pharma packaging improvements cannot be made in isolation but must occur across the spectrum. The government should also enable better enforcement of regulatory standards; improving tracking and visibility across the value chain; plug infrastructure gaps- for e.g. cold chain and packaging must expand and quality, establish skill development and training programmes to enable progress.