The scheme will focus on transforming India into a high-volume, high-value player in the global market of pharmaceuticals, meeting the quality, accessibility, and affordability goals
Dr Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers and Minister of Health & Family Welfare, Government of India recently launched the National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India and Scheme for promotion of Research and Innovation in Pharma MedTech Sector (PRIP). Dr VK Paul, Member, NITI Aayog, S Aparna, Secretary (Pharma), Ministry of Chemicals and Fertilizers and Dr Rajiv Bahl, Director General, ICMR were present at the event.
Accentuating the benefits of the scheme, Dr Mandaviya noted the scheme will focus on transforming India into a high-volume, high-value player in the global market of pharmaceuticals, meeting the quality, accessibility, and affordability goals. He further stated, “The policy will help to create an ecosystem of skills and capacities including the academia and the private sectors, and give impetus to new talent among the youth through start-ups.” This is a transformative stage in the Indian drugs and med-tech sector, he stressed where synergies are being created between various Government institutions and agencies such as the Pharma Dept, ICMR, DST, DBT, NIPER etc.
Dr VK Paul, Member (Health), NITI Aayog said that after learning lessons from the past, India is leading the world. These clusters of reforms will transform the Pharma MedTech Sector. We also need to focus on collaboration between academia and public and private institutions. This scheme and these initiatives will help in preparing us for future challenges and ensuring national biosecurity.
National Policy on Research and Development and Innovation in Pharma MedTech Sector in India
1. As per the Allocation of Business Rules, the Department of Pharmaceuticals has been assigned, amongst others, the work related to promotion and co-ordination of basic, applied and other research in areas related to the pharmaceutical sector; education and training including high-end research; international co-operation in pharmaceutical research, inter-sectoral coordination and all matters relating to National Institutes of Pharmaceutical Education and Research (NIPERs).
2. The Indian pharmaceutical industry is the third largest in the world by volume with a current market size of around $50 billion. The industry could potentially grow to $120-130 billion over the next decade; one of the key drivers for this growth to be expansion of the industry’s presence in the innovation space.
3. Under recommendations of the Parliamentary Standing Committee in its 46th Report, the Department constituted a high-level inter-departmental committee to draft and finalise the policy on R&D and innovation including academia-industry linkage in pharmaceuticals and medical devices consisting of senior representatives of ministries/departments and industry leaders submitted its report in September, 2020.
4. Based on recommendations made in the Report, Draft ‘Policy to Catalyse R&D and Innovation in the Pharma MedTech Sector in India’ has been prepared to encourage R&D in pharmaceuticals and medical devices and to create an ecosystem for innovation in the sector for India to become leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. The policy was notified in the gazette on August 18, 2023. The Policy postulates three main areas of focus to achieve the objectives:
• To create a regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality.
• To incentivise private and public investment in Innovation through a mix of fiscal and non-fiscal measures.
• To build an enabling ecosystem designed to support innovation and cross-sectoral research as a strong institutional foundation for sustainable growth in the sector.
5. It is also proposed to set up an Indian Council of Pharmaceuticals and Med-tech Research and Development to facilitate and promote collaboration among industry, academia and research institutions across Departments, promoting domestic and international collaboration in R&D in Pharma Med-tech sectors.
6. The policy will lead to a higher contribution to the GDP of the 5 trillion economy; increased exports and forex inflow; increase in global market share; increased drug security and availability; improvement of overall healthcare index and reduced disease burden; creation of high-end jobs in R&D and Innovation and opportunity to attract back Indian talent with expertise in R&D and Innovation.
Promotion of Research and Innovation in Pharma MedTech Sector
1. The Indian pharma industry could potentially grow to $120-130 billion over the next decade; one of the key drivers for this growth to be expansion of the industry’s presence in the innovation space.
2. At present a major component of Indian exports is low-value generic drugs while a large proportion of the demand for patented drugs is met through imports. This is because the Indian Pharmaceutical sector lacks high-value production along with world-class pharma R&D. To incentivise the global and domestic players to enhance investment and production in these product categories, a well-designed and suitably targeted intervention is required to incentivise specific high-value goods such as biopharmaceuticals, complex generic drugs, patented drugs or drugs nearing patent expiry, cell-based or gene therapy drugs. The medical device sector is also an essential and integral constituent of the healthcare sector.
3. Govt of India has acknowledged the need for pharma innovation and announced in Budget 23-24 that” A new Programme to promote research and innovation in pharmaceuticals will be taken up through Centres of Excellence. We shall also encourage industry to invest in research and development in specific priority areas.”
4. Accordingly, the Department of Pharmaceutical has proposed PRIP (Promotion of Research and Innovation in Pharma MedTech Sector) scheme with a budget outlay of Rs. 5000 crores notified through Gazette notification on 17th August 2023. The objective of the scheme is to transform the Indian pharmaceuticals sector from cost-based to innovation-based growth by strengthening the research infrastructure in the country. The scheme aims to promote industry-academia linkage for R&D in priority areas to inculcate a culture of quality research and nurture our pool of scientists. This will lead to sustained global competitive advantage and contribute to quality employment generation in the country.
5. The scheme has two components-
Component A: Strengthening the research infrastructure by establishment of 7 CoEs at NIPERs-These CoEs would be set up in pre identified areas with a financial outlay of Rs 700 crores.
Component B: Promoting research in the pharmaceutical sector by encouraging research in six priority areas like New Chemical Entities, Complex generics including biosimilars, medical devices, stem cell therapy, orphan drugs, Anti-microbial resistance etc., wherein financial assistance will be provided for the Industries, MSME, SME, Startups working with government institutes and for both in-house and academic research. The component has a financial outlay of Rs.4250 Crores.
Benefits of the scheme-
1. Development of Research Infrastructure- The scheme would help in building a world-class research atmosphere at NIPERs and other institutes and help in creating a talent pool of qualified trained students.
2. This scheme will promote industry-academia linkages by promoting collaboration between the private sector and government institutes.
3. Focus on certain priority areas which will help India’s pharma industry leapfrog and radically strengthen its position in the world market as innovation accounts for 2/3rd of global pharmaceutical opportunities.
4. The scheme would help in launching commercially viable products which will accelerate the growth of the Indian pharmaceutical sector by increasing revenue and creating employment opportunities.
5. The scheme would help in the development of an affordable, accessible solution for the primary area of health concern thus reducing the health care burden.