“Today is a historic day, an inflection point in the journey of Atmanirbharta in the pharma & medical devices sector. We need to transform Indian Pharma & MedTech sectors from a cost-based to a value-based & innovation-based industry,” stated by Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers and Minister of Health & Family Welfare, Government of India; at the launch of 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) today. Dr V. K. Paul, Member, NITI Aayog, S Aparna, Secretary (Pharma), Ministry of Chemicals and Fertilizers and Dr Rajiv Bahl, Director General, ICMR were also present at the event.
Accentuating the benefits of the scheme, Dr Mansukh 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 Pharma Deptt., ICMR, DST, DBT, NIPER etc.
Reiterating the slogan of ‘Jai Jawan, Jai Kisan, Jai Vigyan and Jai Anusandhan’, he elaborated that India prioritizes growth and innovation in brain power and manpower, wherein Covid is an example where we stood the testimony of the time. We need to do mass production of our pharmaceutical products and medical devices. For this, we have made three bulk drug parks in Himachal Pradesh, Vizag and Gujarat and four medical device parks in Himachal Pradesh, Uttar Pradesh, Madhya Pradesh and Tamil Nadu, which will help in strengthening this sector.
Emphasizing on the importance of the scheme, the Union Minister of Chemical and Fertilizer, Dr Mansukh Mandaviya said, “India can only achieve self-reliance in pharmaceuticals and medical devices by strengthening its research and development infrastructure that would drive the expansion of access to life-saving medicines and drugs and help India become a global pharmaceuticals and medical exports hub.” We need to make policies, new products and new research according to the needs of our country and the world, in consultation with industries and academia. We should become so independent that we should not be dependent on anyone for our critical needs.”
Dr V K 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, public and private institutions. This scheme and these initiatives will help in preparing us for the future challenges and ensuring national bio security.
Senior officials from the Ministry of Health and Family Welfare and Chemicals and Fertilizers were also present at the event along with policymakers, experts from the healthcare and pharmaceutical sector, representatives from academia, think tanks, industry and media.
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. Indian pharmaceutical industry is the 3rd largest pharmaceutical industry in the world by volume with current market size of around USD 50 Billions. The industry could potentially grow to USD 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. Pursuant to recommendations of the Parliamentary Standing Committee in its 46th Report, the Department had constituted a High level Inter- departmental Committee to draft and finalize Policy on R&D and Innovation including Academia-industry linkage in Pharmaceuticals & Medical Devices consisting of senior representatives of ministries/ department 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 in order for India to become leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. The policy has been notified in gazette on 18th August, 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 incentivize 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 higher contribution in 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.
PRIP (Promotion of Research and Innovation in Pharma MedTech Sector)
1. Indian pharmaceutical industry is the 3rd largest pharmaceutical industry in the world by volume with current market size of around USD 50 Billions. The industry could potentially grow to USD 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 are 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 in high value production along with world class pharma R&D. In order to incentivize 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 made announcement in the 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, 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 Indian pharmaceuticals sector from cost based to innovation-based growth by strengthening the research infrastructure in the country. The aim of the scheme is to promote industry-academia linkage for R&D in priority areas and to inculcate the 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 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 talent pool of qualified trained students.
2. This scheme will promote industry-academia linkages by promoting collaboration between Private sector and Govt. 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 of commercially viable products which will accelerate the growth of Indian pharmaceutical sector by increased revenue and creating employment opportunities.
5. The scheme would help in the development of affordable, accessible solution for primary area of health concern thus reducing health care burden.
