How is pharma R&D in India transforming? What are the imperatives that led to this change?
The Indian pharma industry has emerged as a key provider of generic medications to both developing and developed countries. The transformation of India’s pharma business along the R&D value chain indicates a significant change from medication importer to drug inventor. The Indian government’s industrial and technological policies as well as improvements in intellectual property regulation were critical in this expansion of R&D competence. The industry has followed a trajectory from duplicative imitation to creative imitation to rise along the value chain of pharma R&D. Finally, as patent law evolves, the sector is learning to create capabilities in innovative R&D rapidly.
On the other hand, R&D in India for export-oriented items is gradually catching up with other global corporations. In addition to the numerous characteristics listed above, severe regulatory requirements for submission of product dossiers for approval by respective agencies such as the US FDA/EMA/ANVISA have also played a significant role. We have good talent in India, and a majority of Indian companies serving these regulated markets have adequate infrastructure to do research and development, particularly for the formulation of medicinal goods.
From an evolutionary point of view, how has COVID-19 impacted the pharma R&D sector?
The pandemic has had a huge impact on India’s R&D across industries, especially with the pharma sector striving to be strong in this area of critical need despite several issues impeding its growth. For instance, lockdowns and other restrictions enforced to prevent the spread of the virus forced many R&D facilities and labs to stop or significantly reduce their operations and divert their resources towards addressing the immediate needs caused by the outbreak. R&D leaders also saw productivity falling due to working from a distance.
However, the industry demonstrated remarkable resilience in creating solutions to keep operations running during times of uncertainty. There were pharma players who were already performing good research for vaccination, and they cracked the formulation for COVID-19 vaccines in a relatively short time. This rapid development, subsequent clinical testing, and approval by the Indian drug authority demonstrated our capability and intellect.
Can you share some key learnings from your vast expertise to improve the current R&D scenario in India and help advance potential treatments?
The Indian pharma industry has come a long way in R&D development, innovation and government policies to encourage new products in the market. However, to compete with the global market and sustain its title as the “Pharmacy of the world” post-pandemic, the sector must create an inclusive environment for industry leaders and scholars to discuss the current situation and create a path for R&D advancement in the pharma sector.
One such aspect that will fuel this growth is new chemical entities (NCEs). I believe that we have talent in India to crack NCEs, but we need the right infrastructure, investment planning, dedicated research centres, collaboration between universities and industry, and the patience to get success, since NCE development may take 10-15 years.
How is technology ushering new paradigms in pharma R&D? Tell us about the pivotal technologies empowering and enabling pharma companies to improve and accelerate their R&D outcomes. How is Amneal utilising technology to accelerate and enhance the life sciences R&D pipeline?
As per the GlobalData survey in 2022, 70 per cent of the industry respondents anticipate ‘drug development’ to be the most impacted area by implementation of smart technologies.
Because of the challenges and disruptions caused by the coronavirus pandemic, pharma businesses are increasingly adopting cutting-edge technologies such as AI, AR/VR, Big Data, and Quantum Computing to produce personalised solutions, speed up R&D efforts, and alter the user experience.
Most importantly, regulatory agencies are also keeping pace with the speed of industry. Clear guidelines and direction have helped to get faster approvals. For example, Modelling and Simulation for prediction in Bio Study, Stability prediction using software, Design of Experiments, and Quality Target Product Profile (QTPP) based development have expedited the overall development work.
Amneal makes significant investments in high-quality facilities, equipment, technology, and expertise. A few of our more complex capabilities include long-acting depot technology for injectable products and microsphere/multi-particulate-based development and scale-up. The company uses the latest technology in both lab and commercial sizes, and is constantly refining its procedures across its production activities.
Tell us about the growth opportunities opening up in the pharma sector, globally and in India? How is Amneal poised to leverage them? What are your current and future areas of focus? Why?
Globally, the pharma industry is quickly expanding, and India is experiencing tremendous growth in this field too. The worldwide pharma market is booming due to factors such as an ageing population, rising affluence, and more access to healthcare. In India, the government’s emphasis on expanding access to healthcare and the local market is also contributing to the growth of the pharma business. Furthermore, India’s enormous pool of skilled personnel and relatively inexpensive labour costs make it an appealing investment.
Our mission at Amneal is to make ‘healthy’ possible through increased access to the latest innovations in essential medicines, and we aim to leverage the country’s growing offerings in the sector by placing a specific emphasis on innovating products that address the market’s unmet needs. The company is also leveraging these opportunities by developing complex generics, different dosages by repurposing the existing molecules, and working to develop new molecules.