GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- PLI Scheme for Medical Devices – FY 2025-26 Performance Update (ongoing, FY 2022-23 to FY 2026-27): With a total outlay of ₹3,420 crore, the PLI scheme offers 5% incentives on incremental sales of domestically manufactured high-end medical devices in four segments – radiology, cancer care, anaesthesia/cardio-respiratory, and implants. By September 2025, 22 greenfield projects were commissioned and production commenced for over 55 advanced devices including MRI, CT, mammography, ultrasound systems, and linear accelerators, with cumulative eligible sales reaching ~₹12,344 crore and growing export volumes.
- Scheme for Promotion of Medical Device Parks (ongoing; three parks in advanced build-out): The scheme supports common infrastructure for medical device parks to reduce production costs and enhance competitiveness, with three parks approved in Greater Noida (UP), Ujjain (MP), and Kanchipuram (TN) with total project cost of ~₹871 crore and central assistance of ₹100 crore per park. As of late 2025, civil works were in advanced stages and 194 manufacturers had been allotted plots – these parks will co-locate device OEMs, testing labs, sterilisation, and logistics, creating clusters where SIDMA can supply scientific instruments, lab testing equipment, and integration services.
- CDSCO Medical Device Classification & Digital/AI Device Guidance (2025-2026 Update): CDSCO released a revised list of 553 cardiovascular and neurological medical devices re-classified by risk (Class A-D), and published 2026 guidance clarifying classification for Software as a Medical Device (SaMD) and AI-driven tools, emphasising intended use, clinical decision support role, and impact of incorrect outputs. These updates tighten expectations on labelling, marketing claims, and technical documentation for any device in SIDMA’s network that incorporates AI or clinical decision support functionality.
- BIS Acceleration of Standards for Critical Medical Devices – 214 Devices Programme: BIS is fast-tracking standards and certification coverage for approximately 214 key medical devices including ventilators, defibrillators, anaesthesia machines, warmers, and phototherapy units, targeting completion by December 2025. This push tightens quality assurance, patient safety, and harmonisation with international frameworks – device OEMs served by SIDMA will increasingly require BIS-compliant components and subsystems, and SIDMA’s instrumentation and accessories should align to BIS requirements to remain preferred suppliers.
- India-US Medical Devices Trade Framework – Tariff Reduction and Regulatory Reciprocity (reported February 2026): Under a new bilateral understanding, India agreed to ease non-tariff barriers for US medical devices while the US cut tariffs on Indian medical devices from approximately 50% to approximately 18%, providing Indian exporters with a significant cost advantage versus Chinese competitors whose tariffs remain higher. This is expected to unlock substantial MedTech export potential for Indian diagnostic and device manufacturers using SIDMA-supplied scientific and medical subsystems.
- India-EU Free Trade Agreement – Medical Technology Tariff Provisions (crystallised February 2026): The FTA removes or sharply reduces tariffs on most EU-origin medical devices exported to India while also supporting regulatory cooperation and technology transfer. Short-term, EU devices gain price competitiveness in India; medium-term, this may open collaboration avenues for SIDMA to integrate EU technology into locally manufactured scientific and medical platforms and encourage joint ventures.
- Advantage Healthcare India (AHCI) 2026 – BRICS Health Dialogue Track (held 23-25 February 2026): FICCI organised the 8th edition of AHCI alongside a BRICS Health Dialogue track, covering policy and strategy around medical value travel, cross-border healthcare, and health-sector cooperation among BRICS countries, including regulatory facilitation, accreditation, and ecosystem support for international patients. This policy dialogue frames the cross-border patient flows that drive hospital and diagnostic infrastructure investments relevant to SIDMA members.
- FICCI Industry-Academia Conference 2026 – Accelerating Research to Impact (held 16 January 2026, Kolkata): The 4th FICCI Industry-Academia Conference focused on converting research outputs into market-ready innovations through industry-academia partnerships, with sessions on regulatory pathways and commercialisation. It signals government and industry interest in translational research and can shape future grant and incubation landscapes for device and lab-tech startups that will become SIDMA customers.
Actionable Policy Table
| Policy / Reform | What It Does | Why It Matters in the Next 60 Days | Key Action for SIDMA Members |
| PLI Scheme for Medical Devices – Final Operational Year (FY 2026-27) | ₹3,420 crore scheme; 22 greenfield projects in production; 55+ device categories now manufactured domestically | PLI-funded facilities (MRI, CT, LINAC, mammography, ultrasound) are in active production ramp-up and need calibration, QC, and validation instruments now | Identify PLI-commissioned manufacturers from DoP’s project list; contact facility heads with calibration, QC instrument, and validation equipment packages in April-May before their first full-year production audit |
| Medical Device Parks – UP, MP, TN (194 plots allotted; civil works advanced) | Three parks (Greater Noida, Ujjain, Kanchipuram) with 194 manufacturers allotted plots; shared testing and sterilisation infrastructure active | Parks are procuring shared testing, validation, and lab infrastructure as manufacturers move in during April-June 2026 | Contact park management authorities at YEIDA (UP), Ujjain (MP), and TIDCO Kanchipuram (TN) for preferred vendor listings; position QA instruments, calibration equipment, and lab testing solutions for common facility contracts |
| GFR Amendment – Raised Procurement Limits for Scientific Ministries | Direct purchase limit ₹2 lakh; committee limit ₹25 lakh; GTE authority ₹200 crore; non-GeM allowed for specialist items | Active procurement cycle is underway at CSIR, ICMR, IITs, ICAR, DRDO – institutes can buy faster and at higher values without GeM constraints | Deliver GFR-compliant direct-purchase catalogues to DST, ICMR, ICAR, DRDO, DBT purchase officers this week; flag items under ₹2 lakh for instant direct-purchase eligibility; follow up in two weeks |
| SCOMET Category 7 (effective 23 Oct 2025) – Advanced semiconductors, quantum, cryogenic, additive manufacturing | New export-control category; exports of listed items require DGFT licences | Any export since Oct 2025 of advanced sensors, lasers, cryogenic lab gear, or additive manufacturing equipment may have needed a licence – retroactive review is urgent | Audit all export shipments since 23 Oct 2025 for potential Category 7 items at www.dgft.gov.in; obtain retroactive or prospective licences before the next shipment; consult NCSTC handbook for classification guidance |
| CDSCO Classification Update + SaMD/AI Guidance (2026) | 553 cardiovascular/neurological devices reclassified A-D; AI-powered diagnostics under stricter intended-use rules | CDSCO is actively rejecting submissions that don’t match updated risk classifications; SaMD guidance affects any device with clinical decision support | Log in to cdscomdonline.gov.in and reclassify all cardiovascular, neurological, and AI-diagnostic products before your next import or manufacturing licence filing; update labelling and marketing materials to reflect correct risk class |
| India-US Medical Devices Trade Framework – US tariffs cut from 50% to ~18% | Indian medical device exports to US face dramatically lower tariffs; non-tariff barriers eased | US buyers are re-evaluating Indian suppliers in real time; the pricing advantage over Chinese competitors is immediate and actionable | Identify which products in your portfolio meet US FDA requirements or can be adapted to meet them; contact US distributors and buying groups now with revised pricing reflecting the tariff reduction; engage PHARMEXCIL for US market entry support |
| India-EU FTA – Medical Device Tariffs Reduced/Eliminated for EU Imports | EU-origin medical devices get zero or near-zero tariffs into India; regulatory cooperation support | EU devices become more price-competitive in India immediately; Indian OEMs need a response strategy | For importers: adjust pricing models to reflect reduced duty on EU devices. For manufacturers: engage EU OEMs about technology licensing, co-manufacturing, or OEM supply agreements that leverage the regulatory cooperation framework |
| BIS 214 Device Standards Programme (deadline Dec 2025; ongoing enforcement) | 214 critical device standards targeted; 16 new standards effective April 2025; BIS standards embedded in CDSCO evaluations and public procurement | Tenders in Q2 2026 (April-June) will increasingly require BIS compliance certificates; non-compliant products lose eligibility | Audit all product lines against current BIS standards; obtain conformance test reports from NABL-accredited labs for any product entering a government tender in the next 60 days |
| RDI Fund – ₹1 Lakh Crore (₹20,000 crore FY 2025-26 tranche; first approvals mid-2026) | Long-tenure low-interest R&D financing via ANRF; targets biotech, pharma, AI, quantum, deep tech | First project approvals expected mid-2026; funded entities will need advanced lab and scientific equipment within weeks of disbursement | Register vendor interest on rdifund.anrf.gov.in; monitor ANRF for Focused Research Organisation approvals; position advanced analytical, lab automation, and testing instruments with newly funded projects early |
| NCSTC 2026 – Updated SCOMET Handbook released | Third edition of India’s Strategic Trade Control Handbook published; new export-control expectations formalised | Companies with international shipments of lab, medical, or dual-use scientific equipment must update their internal compliance programmes | Download and review the updated SCOMET Handbook from www.dgft.gov.in; update internal export classification protocols; train sales and logistics teams on Category 7 and intangible technology transfer (ITT) requirements |
Disclaimer: Policy details are current as of 29 March 2026. Cross-reference with government portals: DGFT (www.dgft.gov.in) | CDSCO (www.cdscomdonline.gov.in) | DST (www.dst.gov.in) | ANRF (www.rdifund.anrf.gov.in) | BIS (www.bis.gov.in) | DoP (www.pharmaceuticals.gov.in) | MyMSME (www.my.msme.gov.in).