"Today is a historic day, an inflection point in the journey of "Atmanirbharta" in the pharma & medical devices sector." We must transform the Indian pharmaceutical and medical technology sectors from a cost-based to a value-based and innovative industry."

Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers and Minister of Health and Family Welfare, Government of India, made this statement today at the launch of the National Policy on Research and Development and Innovation in the Pharma-MedTech Sector in India and the Scheme for Promoting Research and Innovation in the Pharma-MedTech Sector (PRIP).

Dr. V. K. Paul, Member, NITI Aayog, S. Aparna, Secretary (Pharma), Ministry of Chemicals and Fertilizers, and Dr. Rajiv Bahl, Director-General, ICMR, were in attendance at the event.

Dr. Mandaviya emphasized the scheme’s aim to elevate India into a prominent global player in the pharmaceutical market, with a strong emphasis on quality, accessibility, and affordability.

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.

Emphasising on the importance of the scheme, Dr 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. Paul highlighted India’s leadership in the world, drawing from past lessons. These reform clusters will reshape the pharma-medtech sector, stressing the importance of collaboration among academia, public, and private institutions. He noted that these initiatives and the scheme are instrumental in preparing for future challenges and ensuring national biosecurity.

Regarding the National Policy on Research and Development and Innovation in Pharma-MedTech Sector in India:

1. The Department of Pharmaceuticals, following Allocation of Business Rules, is responsible for advancing pharmaceutical sector research, education, international collaborations in research, and oversight of National Institutes of Pharmaceutical Education and Research (NIPERs).
2. India’s pharmaceutical industry is the third-largest globally by volume, valued at approximately USD 50 billion, with potential growth to USD 120-130 billion in the next decade, driven by innovation.
3. In response to the 46^th Report of the Parliamentary Standing Committee, an Inter-departmental Committee was established to draft the policy on R&D and Innovation in Pharmaceuticals & Medical Devices, submitted in September 2020.
4. A draft policy based on committee recommendations aims to boost R&D in pharmaceuticals and medical devices, foster innovation, position India as a leader in drug discovery and medical devices, officially notified on August 18, 2023. It emphasizes regulatory support, investment incentives, and an enabling ecosystem.
5. There is a proposal to create the Indian Council of Pharmaceuticals and Med-tech Research and Development to promote collaboration among industry, academia, and research institutions in Pharma-MedTech R&D, domestically and internationally.
6. Implementation of the policy is expected to benefit India’s GDP, exports, healthcare indicators, job creation in R&D and Innovation, and attract skilled talent in these fields, while enhancing drug security and availability and reducing disease burden.

Regarding PRIP (Promotion of Research and Innovation in Pharma-MedTech Sector):

1. India’s pharmaceutical industry ranks third globally by volume, valued at approximately USD 50 billion, with the potential to reach USD 120-130 billion in the next decade, driven by innovation.
2. To encourage domestic and global investment in high-value pharmaceutical production and cutting-edge R&D, there’s a need to focus on biopharmaceuticals, complex generics, patented drugs, cell-based/gene therapy drugs, and medical devices. These elements are crucial for the healthcare sector, as India largely exports low-value generic drugs and imports patented ones.
3. The Indian government acknowledged the importance of pharmaceutical innovation and initiated a program in the 23-24 Budget to promote research and innovation in pharmaceuticals through Centers of Excellence, encouraging industry investment in priority areas.
4. The Department of Pharmaceuticals has proposed the PRIP (Promotion of Research and Innovation in Pharma-MedTech Sector) scheme with a budget of Rs. 5,000 crores, officially notified on August 17, 2023. The scheme aims to shift the Indian pharmaceutical sector from cost-based to innovation-based by strengthening research infrastructure, fostering industry-academia collaboration, and nurturing a culture of quality research.
5. The scheme comprises two components: Component A involves establishing seven Centers of Excellence (CoEs) at NIPERs in predefined areas, with a budget of Rs. 700 crores. Component B focuses on promoting research in six priority areas, including New Chemical Entities, Complex generics, medical devices, stem cell therapy, orphan drugs, and Anti-microbial resistance, with a budget of Rs. 4,250 crores.

Benefits of the scheme include developing research infrastructure, promoting industry-academia collaboration, enhancing India’s global pharmaceutical presence, launching commercially viable products, and providing affordable healthcare solutions to alleviate healthcare burdens.

Pavan Choudary, Chairman, Medical Technology Association of India (MtaI) mentions, “The PRIP Scheme will undoubtedly catalyse the growth of innovative MedTech portfolio in India. We are encouraged by the government’s focus on R&D as it aims to utilize India’s existing strengths.”

“While India has only 1.5 per cent of the global medical device market, it has 8 per cent share of the global medtech R&D work force. This is a fertile and proven area that the government has rightly identified to build on. It is a policy which harnesses both the domestic and international currents to optimally forge the path ahead.”