Blog by Bhumika Kabadi (R&D associate).

PRIP —Scheme for Promotion of Research and Innovation in

Pharma MedTech Sector.

Introduction: In the dynamic landscape of pharmaceuticals and MedTech, continuous research and innovation are pivotal. Recognizing this, the Ministry of Chemicals and Fertilizers has introduced the Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme under the Department of Pharmaceuticals. With ongoing research being the cornerstone of the pharmaceutical sector, PRIP aims to enhance India’s global market share, promoting innovation, and fostering sustainable growth.

Indian pharma holds 3.4% of the global market with strategic growth, it could reach proximately 4% by 2030, valued at 130 billion USD, and 5% at 160 billion USD. Indian pharma grows in generic drugs but is lacks in R&D spending compared to the US and China Increasing R&D investment and focusing on new areas is crucial for industry growth.
The scheme will be executed by a Project Management Agency (PMA) responsible for secretarial, management, and implementation support (Yet to be appointed).

Objectives:

• Promote innovation and research by expanding regulatory goals beyond safety and quality in product development.
• Encourage innovation investments with fiscal and non-fiscal incentives.
• Establish a supportive innovation ecosystem for sustainable sectoral growth.

Scheme: The scheme is proposed to having component as follow:
Component B: Promotion of Research in Pharma MedTech sector:

Category – B 1:
• Companies must collaborate with institutions, using their R&D facilities.
• Training students/scientists is mandatory.
• Projects get up to 35% funding or 125 Cr, whichever is lower, over 5 years, following a milestone-based approach from TRL 1 to TRL 9, with benefit sharing.

Category – B 2:
• Financial aid will be provided to 30 research projects at TRL 5, aiming for TRL 9, in priority areas.
• Funding, up to 35% of the cost or ₹100 Cr (whichever is lower), will be provided over 5 years,
following the benefit-sharing principle.
Project selection criteria include: TRL level (Technology readiness level), commercial potential, Societal impact, Affordability, Revenue model, Company’s past performance.

Benefit: Royalty starts at first product sale, ends after full payment or project termination.
a. 10% royalty has been paid till the patent is effective or in the form of equity.
b. In case of Foreclosure or Termination of the Project.

Category – B 3:
• The Department of Pharmaceuticals (DoP) will fund research projects in six priority areas, aiding Indian start-ups and MSMEs to reach TRL 4.
• Financial support, up to ₹1 Cr per project over five years, will be provided for around 125 selected projects.
• Funding will be milestone based and will operate on a royalty-sharing basis.

Indicative criteria:
• Registration Requirement: SMEs, MSMEs, and start-ups must be DPIIT registered.
• Collaboration Preference: Start-ups with industry-academia collaboration.
• Selection Criteria: Factors include research talent, infrastructure, unmet needs, disease targeting, IP generation, and commercial viability.
• Royalty Payment: Beneficiaries pay 5% royalty until it equals DoP’s project assistance.
• Technology Transfer: DoP may seek payment for technology transfer to third parties for
commercialization.

Component	Categories Description	Funding (₹ Cr)	No. of Projects	Funding per Participant (₹ Cr) over 5 Years	Eligible R&D Fund over 5 Years (₹ Cr)	Total Fund per Year (₹ Cr)	Total Funding for 5 Years (₹ Cr)
I	Category – B I	35% or 125 whichever is minimum/participant over a period of 5 year.	9	125	1125	850	4250
II	Category – B II	@35% or ₹ 100 Cr whichever is minimum / participant over a period of 5 years.	30	100	3000
II	Category – B III	1 Cr over a period of 5 years on milestone based.	125	1	125
Total		4950	164		4250		4250
Admin cost		50
Total outlay For Scheme		5000

Conclusion:

PRIP stands as a beacon for the Indian pharmaceutical and MedTech industries, propelling them into a future marked by innovation, collaboration, and global competitiveness. By nurturing research, fostering partnerships, and providing financial support, PRIP paves the way for a transformative journey, ensuring India’s significant presence on the global stage.

The scheme is expected to be officially notified tentatively in December 2023.

Once the Project Management Authority (PMA) is appointed.

For further clarification on the details, please feel free to get in touch with us for more information.

helpdesk@scinnovation.in, Mobile No.: +91-9962696204.

For Further Information:
Gazette Notification
Department of Pharmaceuticals