New Policy and Scheme launched for Pharma MedTech Sector

Dr. Mansukh Mandaviya, Union Minister of Chemicals and Fertilizers and Minister of Health & Family Welfare, Government of India 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)

About 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 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 cooperation 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 3rd largest pharmaceutical industry in the world by volume with a current market size of around USD 50 Billion and innovation gives the space to increase to USD 120-130 Billion over the next decade.

3. The Parliamentary Standing Committee in its 46th Report, recommended the Department of Pharmaceuticals to constitute a High-level Interdepartmental Committee to draft and finalize a policy on R&D and Innovation including Academia-industry linkage in Pharmaceuticals & Medical Devices consisting of senior representatives of ministries/ department and industry leaders. The report was in September 2020.

4. Based on recommendations in the Report, the Draft ‘Policy to Catalyse R&D and Innovation in the Pharma MedTech Sector in India’ was prepared. The policy was notified in the gazette on 18th August 2023.

5. The objectives of the policy are:

  •  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 ecosystem designed to support innovation and cross-sectoral research for sustainable growth in the sector.

6. 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.

7. The policy will lead to:

  • higher contribution to the GDP
  • 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
  • opportunity to attract back Indian talent with expertise in R&D and Innovation.

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

1. 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 in high-value production along with world-class pharma R&D. 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.

2. Govt of India has acknowledged the need for pharma innovation and made the announcement in Budget 23-24 to bring a new Programme to promote research and innovation in pharmaceuticals through Centres of Excellence (CoEs).

3. 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.

4. 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
  • to promote industry-academia linkage for R&D in priority areas
  • to inculcate the culture of quality research and nurture our pool of scientists
  • to have a sustained global competitive advantage
  • to 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 2/3rdof 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.

Posted in Current Affairs.