Government Releases Medical Device Scheme Data; PLI Investment Reaches ₹1,153 Crore, FDI Stands at ₹17,201 Crore
In a written reply in the Lok Sabha, Union Minister for Chemicals and Fertilisers Jagat Prakash Nadda released the latest status report on key government initiatives driving India’s MedTech sector.
Highlighting progress across the Production Linked Incentive (PLI) Scheme, the Medical Device Parks Scheme, and the Scheme for Strengthening of Medical Device Industry (SMDI), the report demonstrates significant growth in domestic manufacturing, infrastructure expansion, and foreign direct investment.
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1. Production Linked Incentive (PLI) Scheme
- Financial Outlay: ₹3,420 crore covering four key target segments: cancer care/radiotherapy, radiology & imaging equipment, anaesthetics/cardio-respiratory & renal care, and implants.
- Approved Applications: 27 applications approved, including 14 from MSMEs.
- Actual Investment & Incentives: Reported actual investment reached ₹1,153.07 crore, with ₹266.64 crore in incentives released up to FY2024–25.
- Manufacturing Milestone: Commercial production has already commenced for high-end equipment including CT and MRI machines, linear accelerators (LINACs), mammography systems, C-arms, ultrasound systems, heart valves, and stents.
2. Medical Device Parks Scheme
- Infrastructure Hubs: Dedicated parks are under development in Noida (Uttar Pradesh), Ujjain (Madhya Pradesh), and Kancheepuram (Tamil Nadu).
- Facilities: Parks offer common infrastructure such as testing laboratories, sterilization units, warehousing, incubation hubs, and prototyping centers.
- Progress: 210 manufacturing units have been allotted plots across the three locations, with ₹177.98 crore utilized out of ₹209.80 crore central assistance released.
3. SMDI Projects and Sectoral Growth
- SMDI Outlay: ₹500 crore allocated for the FY2024–25 to FY2027–28 period.
- Import Reduction & Clusters: 24 projects approved with ₹101.50 crore in grants under the Marginal Investment Scheme for Reducing Import Dependence (MIS-RID). An additional 13 cluster projects received approvals amounting to ₹88.67 crore.
- MSME & Startup Push: Seven approved projects targeting high-precision instruments are being spearheaded by MSMEs, including four innovative startups.
4. Robust Foreign Direct Investment (FDI)
Foreign direct investment in India’s MedTech sector reached ₹17,201 crore between FY2021–22 and FY2025–26, reflecting mounting global confidence in India as an emerging hub for medical device manufacturing.
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How Operon Strategist Can Help
With government schemes like PLI, SMDI, and Medical Device Parks driving rapid expansion and investment in India’s MedTech sector, manufacturers, MSMEs, and foreign investors must align their facility planning and technical documentation with strict regulatory standards. Operon Strategist offers end-to-end consulting services to help organizations leverage these incentives, set up compliant facilities, and accelerate market access.
Our key services include:
- Plant Layout Detail Engineering & Facility Design: Designing audit-ready manufacturing facilities for plots in Medical Device Parks in full compliance with Schedule M-III and QMS requirements.
- Product Process Engineering & Design Development: Assisting manufacturers under PLI and SMDI schemes with New Product Design Development, Product Feasibility, and process optimization for high-precision medical instruments.
- CDSCO Medical Device Registration: Managing end-to-end CDSCO (India) licensing, classification, manufacturing site approvals, and regulatory submissions.
- Quality Management System (QMS) & Technical Documentation: Implementing ISO 13485 QMS frameworks and constructing compliant Design History Files (DHF).
- Global Product Registration & Due Diligence: Facilitating international expansion and FDI investments through CE Marking (EU MDR/IVDR), US FDA (510(k) & QMSR), and Regulatory Due Diligence for Medical Devices.
Our team works closely with medical device manufacturers, startups, and international investors to simplify regulatory compliance, streamline plant engineering, and ensure the successful commercialization of compliant medical technologies.