India Boosts Pharma & MedTech R&D with ₹5,000 Cr PRIP Scheme

The Indian government has taken a significant step in bolstering research and development (R&D) in the pharmaceutical and medical technology (MedTech) sectors. The Department of Pharmaceuticals, under the Ministry of Chemicals and Fertilizers, has rolled out a 32-page Expression of Interest (EoI) document to invite companies and research institutions to participate in the country’s growing innovation ecosystem.

This initiative is part of the Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme, which was announced in the 2023 Union Budget by Finance Minister Nirmala Sitharaman. With a total financial outlay of ₹5,000 crore, this scheme is designed to position India as a global leader in medical innovation, complex drug formulations, and precision medicine.

Government’s Vision for the Pharma and MedTech Sector

The pharmaceutical industry has long been a pillar of India’s economy, with the country being recognized as the “pharmacy of the world” due to its large-scale production of generic medicines. However, the government now seeks to move beyond generics by promoting high-value R&D projects that will lead to groundbreaking drug discoveries and cutting-edge medical devices.

The PRIP scheme aims to transform India into a powerhouse of R&D in the Pharma MedTech sector, fostering homegrown innovations that can compete on a global scale. The scheme will support research in six priority areas, providing funding across three categories to accelerate investments in advanced drug and MedTech development.

Key Priority Areas in PRIP Scheme

The PRIP scheme targets six key areas in pharmaceutical and medical technology research:

1. New Chemical Entities (NCEs), New Biological Entities (NBEs), and Phyto-pharmaceuticals
   • Encourages research into new drug molecules that have never been approved for human use.
   • Focuses on herbal and plant-based medicines with scientific validation.
2. Complex Generics and Biosimilars
   • Supports the development of complex generic drugs that require advanced formulations.
   • Encourages biosimilar production to reduce dependence on high-cost biologics.
3. Precision Medicine and Targeted Innovative Therapeutics
   • Promotes personalized medicine tailored to individual genetic profiles.
   • Supports innovative treatments for diseases like cancer, diabetes, and neurological disorders.
4. Medical Devices
   • Aims to boost indigenous manufacturing of high-tech medical devices.
   • Supports innovations in diagnostics, imaging, and surgical tools.
5. Orphan Drugs for Rare Diseases
   • Encourages research on drugs for diseases that affect a small percentage of the population.
   • Seeks to address unmet medical needs in rare genetic conditions.
6. Drug Development for Antimicrobial Resistance (AMR)
   • Focuses on finding new antibiotics and antimicrobial therapies.
   • Addresses the global health threat of antibiotic-resistant bacteria.

Funding Categories and Eligibility Criteria

The scheme is designed to provide funding under three different categories based on the scale and technology readiness of the projects.

1. Large-Scale Pharma and MedTech Companies

• Funding up to 35% of the total project cost or ₹125 crore (whichever is lower).
• Eligible companies must have annual revenue above ₹1,000 crore (Pharma) or ₹250 crore (MedTech).
• Must collaborate with government research institutions and work on priority areas.

2. Medium-Sized Enterprises and Research Organizations

• Funding up to 35% of the total project cost or ₹100 crore (whichever is lower).
• Open to entities working on R&D projects in advanced technology readiness levels (TRL 5 or 6).

3. Startups and MSMEs (Micro, Small & Medium Enterprises)

• Funding up to ₹1 crore per project.
• Open to early-stage projects with TRL 1 to 4.
• Focused on fostering innovation in young companies and academic institutions.

Understanding the Technology Readiness Levels (TRLs)

Technology Readiness Levels (TRLs) provide a structured pathway from concept to commercial deployment. The PRIP scheme follows the TRL framework, which includes:

1. TRL 1 – Basic idea and conceptualization of the research.
2. TRL 2 – Initial formulation of hypotheses and scientific principles.
3. TRL 3 – Experimental proof of concept.
4. TRL 4 – Early laboratory studies and feasibility testing.
5. TRL 5 – Validation of the technology in a simulated environment.
6. TRL 6 – Prototype development and demonstration.
7. TRL 7 – System prototype tested in real-world conditions.
8. TRL 8 – Final refinement and pre-commercial deployment.
9. TRL 9 – Full deployment and commercialization of the product.

Potential Impact of the PRIP Scheme

The launch of this scheme is expected to have far-reaching effects on India’s healthcare sector and economy.

1. Boosting Domestic R&D
   • Encourages Indian companies to invest in new drug discoveries and medical devices.
   • Reduces dependence on imported pharmaceuticals and advanced medical technologies.
2. Attracting Foreign Investments
   • Creates opportunities for multinational corporations to set up R&D centers in India.
   • Strengthens India’s position in the global pharmaceutical supply chain.
3. Enhancing Healthcare Access
   • Development of cost-effective biosimilars and generics will make life-saving drugs more affordable.
   • Indigenous production of medical devices can lower costs for Indian healthcare providers.
4. Job Creation and Skill Development
   • Expansion of R&D facilities will create high-skilled jobs for researchers, scientists, and engineers.
   • Encourages academic institutions to collaborate with industry leaders in innovation.
5. Strengthening India’s Global Standing
   • Positions India as a leading hub for pharmaceutical and MedTech innovation.
   • Increases exports of high-value pharmaceuticals and medical devices.

Challenges and the Road Ahead

While the scheme presents an ambitious vision, its success depends on various factors:

1. Regulatory Approvals – Accelerating approval processes for new drugs and medical devices is crucial.
2. Infrastructure Development – Establishing world-class research labs and testing facilities.
3. Collaboration with Academia – Strengthening industry-university partnerships for knowledge exchange.
4. Encouraging Private Sector Participation – Ensuring robust funding and risk-sharing mechanisms.

The Promotion of Research and Innovation in Pharma MedTech Sector (PRIP) scheme is a transformative step towards making India a global leader in pharmaceutical and medical technology innovation. With a dedicated funding allocation of ₹5,000 crore, the initiative seeks to bridge the gap between traditional generics manufacturing and cutting-edge drug and medical device development.

By encouraging research in precision medicine, complex generics, orphan drugs, and antimicrobial resistance, India is poised to tackle some of the biggest healthcare challenges of the modern era. If successfully implemented, the PRIP scheme will not only boost India’s pharmaceutical R&D ecosystem but also contribute to improved healthcare outcomes, economic growth, and global medical advancements.