India gets a national policy on Pharma-MedTech R&D, Rs 5,000 Crore PRIP scheme for industry

New Delhi: On 26th September, the Government of India announced 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).

Calling it an inflection point in the journey of country’s self-dependence in the pharma and medical devices sector, Dr Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers and Minister of Health & Family Welfare emphasized on the need to transform Indian Pharma & MedTech sectors from a cost-based to a value-based & innovation-based industry.

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.”

MedTech industry positive about the policy

The PRIP Scheme will undoubtedly catalyze the growth of innovative MedTech portfolio in India, said Pavan Choudary, Chairman, Medical Technology Association of India (MTaI). “We are encouraged by the government’s focus on R&D as it aims to utilise India’s existing strengths. While India has only 1.5% of the global medical device market, it has 8% 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,” Choudary added.

Association of Indian Medical Industry (AiMeD) Forum Coordinator Rajiv Nath has hailed PRIP scheme as a “noble and ambitious intent” of Prime Minister Narendra Modi, which will give a boost to Atma Nirbhar Bharat campaign.

“Instead of going for a cost cutting volume-based approach, we should focus on promoting indigenous R&D and innovation. The public procurement system needs to incentivize innovation, I am glad to hear the Honourable Minister empathize with the innovators that it’s understandable that they will not be having market standing initially or even no turnover. I am glad to share here that many of MSMEs in the medical devices sector have hugely invested in R&D and they are making world class devices, which are affordable and much better than the refurbished imported ones, these efforts need recognition and support,” said Nath.

Decoding the policy

Pursuant to recommendations of the Parliamentary Standing Committee in its 46^th 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.

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 18^th 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.

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.

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.

What is PRIP or the Promotion of Research and Innovation in Pharma MedTech Sector?

Department of Pharmaceutical has proposed PRIP (Promotion of Research and Innovation in Pharma MedTech Sector) scheme with a budget outlay of Rs 5000 crores was 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.

The scheme has two components- One is about 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.

Second component is about 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.

Expected benefits of the scheme

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. This scheme will promote industry-academia linkages by promoting collaboration between Private sector and Govt. institutes.

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. It would help in the development of affordable, accessible solution for primary area of health concern thus reducing health care burden.