Over the last two years, there have been significant changes in the way innovative pharmaceutical
companies were perceived by public around the world. Leading the way during the pandemic, global
pharmaceutical companies were able to leverage their existing partnerships with academic
institutions, non-profit organizations, government and regulatory bodies, to bring out lifesaving
solutions to meet the needs of the public in record time. This collaboration on a global scale led to
protecting millions of lives.
India had a very important role to play in this global transition by developing and distributing vaccines
to the world. There also are a few significant gaps that need to be addressed and filled to truly and
rationally enable India deliver the promise of being the ‘Pharmacy to the World’ and probably move
forward in the direction of being a ‘Powerhouse of Research’ in the years to come. The learnings from
the last two years will guide the healthcare, life sciences and the medtech industry on the way forward
for the next 25 years.
Reimagining the drug journey
The supply chain begins with drug discovery, drug approval process and ends with patient treatment. The operational steps required to manufacture and transport the medication to those in need have repetitive steps that are time-consuming and costly. Innovative solutions in the supply chain management process can significantly reduce the cost and time to market. This can be done through:
- AI/ ML and predictive analytics: Implementing an AI/ ML strategy can significantly speed go-to-market time for new drugs by analysing vast amounts of data quickly, assessing hidden correlations, and generating new results. This will also result in a significant reduction in time and material wastage
- Industrial Internet of Things: An ecosystem where every device, machine, and process is connected via a data communication system from drug discovery to delivery of treatment. This can be achieved through a connected ecosystem that will allow real-time monitoring by tracking equipment and process performance
- Smart transportation: To prevent theft or pilferage innovations like ‘Intelligent mobility, which allow step-to-step tracking of raw materials and medications could be leveraged
Focus on Research and Development
India is making significant strides in moving up the value chain towards innovation. Indian Pharma companies spend approx. 8-13% of their total turnover on R&D. This is on a lower side compared to global industry standards of an average of 25% of their revenues owing to constraints such as a gap in harmonization within the regulatory setup, extended approval timelines, limited expertise in conducting, evaluating and inspecting clinical trials, limited infrastructure, and low funding. Additionally, market factors such as price controls and laxity in patent protection also act as deterrents. To further boost R&D in the country, some key enablers can be ensured:
- Strong implementation & enforcement of Intellectual Property Rights (IPR) to protect innovative drugs against the provision of affordable drugs & faster resolution of legal issues on patent infringement.
- Increased harmonization of regulatory authority with PIC/S (Pharmaceutical Inspection Co-operation Scheme) so that we are involved in the development of International Good Manufacturing Practises (GMP) guides and guidelines. This might result in indirect benefits like reduced duplication of inspections, cost savings, export facilitation, and enhanced market access.
- A synergistic collaboration between all government regulatory bodies like the Central Drug Standard Control Organisation i.e. CDSCO & State Drug Regulatory Authorities i.e. SDRA to accelerate the usually lengthy cycle of approvals.
- Leveraging the existing strengths of Contract Drug Manufacturing Organizations from being manufacturing services to being a one-stop-shop for product innovation & development. As of today, 70% of new products being launched in IPM are coming from leading CDMOs
Flexible pricing strategy
In India, different socio-economic segments seek treatment through different channels. Going forward, we need to start discussing offering a well-implemented differential pricing or tiered pricing model as the first step to cater fairly to different patient segments.
- To date, differential pricing across the world has been limited to vaccines, contraceptives and antiretrovirals. It is high time we start exploring the same for innovative life-saving drugs, chronic therapies, and patented introductions since these are a result of years of R&D & preceded by multiple failed attempts. Thus, applying traditional standards (e.g. price- cost comparison) may not be the best solution.
- Trade margin Rationalisation (TMR) approach is also a viable policy alternative that imposes a cap on upstream margin across the entire value chain, rather than capping the price of downstream products. This may help retain the industry’s incentive to innovate at the same time reduce the cost of burden on patients.
An encouraging regulatory environment & policy reforms
A ‘single window system’, eliminating multiple overlapping regulatory bodies & establishing detailed & clear guidelines is paramount to ensuring a vibrant innovation ecosystem. India needs to have a string and clear IP regime to protect innovative drugs against the provision of affordable drugs & faster resolution of legal issues pertaining to patent infringement.
- There is a need for ‘Utility Patent Protection’ to allow innovator companies & SME’s safeguard their inventions which are incremental & tangible in nature & hence, act as an encouragement under the ‘MAKE IN INDIA’ initiative of the government. Some of the countries offering this are USA, China, Japan, Brazil amongst others.
- Increased harmonization of regulatory authority: India on its way of becoming a member of the International Council for Harmonisation (ICH), needs to play a leading role in the development of technical guidelines and requirements for pharmaceutical product registration, This way, it can contribute to the timely introduction of new medicines, prevention of unnecessary duplication of clinical trials in humans, and to the manufacturing of safe, effective, and high-quality medicines a cost-effective manner.
- As a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme), we need to be actively involved in the development of International Good Manufacturing Practises (GMP) guides and guidelines. This has indirect benefits like reduced duplication of inspections, cost savings, export facilitation, and enhanced market access.
- There is a scope for our regulations to evolve and emerge at-par with global standards. This will enable a patient centric and conducive environment for research and development of world-class biosimilars that can then be eligible for world-wide registration or acceptance based on the quality of data generated. We should also innovate in the way we are generating safety data today. India has matured to generate country specific data based on independent academic-industry collaborations. This to a large extent can replace the current mandate of a repeat of phase IV clinical studies. Along the way, we should also think about furthering science-based reliant pathways for early regulatory approvals based on robust science-based assessments by reference countries. This will tremendously accelerate access to innovative life-changing medicines in India as well at the same time as other countries.
To summarise, the future of Innovative and science-based life science companies looks bright in India as there is enough momentum over the last two years to cover the gaps in meeting the final goal of optimal patient outcomes through their products and services. Innovation will thrive further if we have a holistic eco-system where pharma companies can be incentivised through public procurement to bring life changing innovative solutions to continually elevate standard of care.
The next 25 years will be a testament to the learnings gathered by pharmaceutical companies as they continue to work towards focused and sustainable R&D based solutions that will make healthcare more accessible to the common man.
Gagandeep Singh, Country President AstraZeneca India