Publisher
Medical Device Regulatory News and Industry Insights
Overview
The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Government of India, has announced the second call for applications under the Promotion of Research and Innovation in Pharma & MedTech (PRIP) Scheme. With a total financial outlay of ₹5,000 crore, the scheme provides grants and financial assistance to startups, MSMEs, and established pharmaceutical and medical device companies to advance high-impact research toward commercialization.
Out of the total outlay, ₹700 crore is allocated to establish Centers of Excellence (CoEs) across seven National Institutes of Pharmaceutical Education & Research (NIPERs), while ₹4,200 crore is directly earmarked to accelerate R&D investments across the industry.
1. Breakdown of PRIP Scheme Funding Tracks
The second call categorizes support into two distinct funding tracks based on the project’s Technology Readiness Level (TRL):
| Parameter | Early-Stage Projects | Later-Stage Projects |
| Eligible Entities | Startups and MSMEs only | Industry, Startups, and MSMEs |
| TRL Entry & Target | Completed TRL 1, 2, or 3 (advancing up to TRL 5) | Completed TRL 4, 5, or 6 (advancing to higher TRLs) |
| Max Financial Support | Up to ₹5 Crore per project | Up to ₹100 Crore per project |
| Funding Assistance Ratio | • 100% funded for projects up to ₹1 Cr • Up to 50% assistance for ₹1 Cr – ₹5 Cr | • Up to 35% of total project cost • Up to 50% for Strategic Priority Innovations |
| Application Process | Two-step process: Concept Note submission followed by detailed application | Direct submission of Detailed Application Form |
2. Priority Focus Areas for MedTech & Pharma Innovation
To qualify for funding under the PRIP Scheme, proposed projects must fall within defined high-value priority segments:
Medical Device & Digital Health Innovations
Software & AI: AI/ML-based medical devices, Software as a Medical Device (SaMD), and Software in Medical Device (SiMD).
Advanced & Robotic Systems: Robotic surgical platforms, navigation systems, and telemedicine-integrated devices.
Diagnostics & IVDs: Novel In-Vitro Diagnostics (IVDs), point-of-care test kits, molecular diagnostics (PCR, NGS), and biomarker-based precision medicine devices.
Implants & Therapies: Functional dynamic implants (pacemakers, deep brain stimulators), structural implants, and genetic screening tools.
Pharmaceutical & Biopharmaceutical Innovations
New Medicines: New Chemical Entities (NCEs), New Biological Entities (NBEs), cell and gene therapies, and phytopharmaceutical drugs.
Complex Generics & Biosimilars: Novel Drug Delivery Systems (NDDS), modified dosage/indications, and complex biologics.
Strategic Priority Innovations (SPI): Solutions targeting Neglected Tropical Diseases (dengue, chikungunya, rabies), Rare Diseases in India, Antimicrobial Resistance (AMR) pathogens, and pandemic preparedness vaccines.
3. Application Process & Submission Timeline
The portal for submitting applications under the Second Call will open by mid-September 2026 on the official PRIP Scheme Portal.
Key Submission Guidelines:
Two-Step Screening for Early Stage: Early-stage applicants must first submit a short Concept Note. Shortlisted applicants will be invited to submit full proposals.
Documentary Prerequisites: Applicants must furnish incorporation certificates (DPIIT/Udyam), 3-year audited financial statements, audited cap tables, and detailed project milestone maps.
CDSCO Risk Classification: Medical device proposals require clear classification of the device’s regulatory risk (Class A, B, C, or D) and predicate device status.
Resubmission Policy: Projects submitted during the first PRIP round cannot be resubmitted without major modifications.
Accelerate Market Access with End-to-End Regulatory Guidance
How Operon Strategist Can Help
Navigating the PRIP Scheme application process requires aligning complex R&D objectives with rigorous CDSCO regulatory pathways, TRL documentation, and technical compliance standards. Operon Strategist provides specialized technical and regulatory support to ensure your PRIP proposal meets all government evaluation criteria.
Our point-wise support services include:
CDSCO Medical Device Registration & Risk Classification: Expert advisory to accurately determine your product’s CDSCO risk classification (Class A–D), assess predicate device status, and establish a clear regulatory approval roadmap.
Quality Management System (ISO 13485) Implementation: Establishing audit-ready QMS structures and Design History Files (DHF) required to demonstrate manufacturing readiness during PRIP evaluation stages.
Software as a Medical Device (SaMD / AI) Compliance: Guidance on technical file creation, IEC 62304 compliance, and software validation protocols for AI/ML and digital health funding applicants.
Plant Layout & Infrastructure Engineering: Designing regulatory-compliant manufacturing facilities and cleanrooms for medical devices.
Publisher | Medical Device Regulatory News and Industry Insights
The Operon Strategist Editorial Team publishes news, updates, and insights on medical device regulations, regulatory policy changes, and global healthcare industry developments. The team covers key regulatory frameworks, including CDSCO, US FDA, EU MDR, ISO 13485, and international market access requirements, helping medical device manufacturers and healthcare businesses stay informed about evolving regulatory expectations.
