GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- Research, Development and Innovation (RDI) Scheme Fund – ₹1 Lakh Crore Corpus (launched 3 November 2025): The scheme establishes a ₹1 lakh crore corpus over six years (initial ₹20,000 crore in FY 2025-26) providing long-tenure, low or zero-interest financing to private-sector R&D projects in strategic and deep-tech sectors via a fund-of-funds structure anchored by DST and ANRF. This will indirectly boost demand for advanced scientific instruments, lab automation, and medtech prototyping as large R&D projects in biotech, pharmaceuticals, materials, and AI-driven health require sophisticated analytical and pilot-scale equipment.
- Draft Amendments to Medical Devices Rules 2017 – G.S.R. 883(E) (draft published 4 December 2025): The Ministry of Health & Family Welfare proposes perpetual validity for manufacturing and import licences/registration certificates (Forms MD-5, MD-6, MD-9, MD-10, MD-15, MD-40) subject to payment of retention fees, and introduces a new Form MD-44 for test and evaluation reporting. It also refines Class A device labelling (use of “Registration No.”) and tightens post-market surveillance documentation – overall intent is to simplify business continuity while strengthening safety oversight.
- PLI Scheme for Medical Devices – 2025 Performance Update (ongoing, FY 2022-23 to FY 2026-27): With a financial outlay of ₹3,420 crore, the PLI scheme incentivises incremental sales of domestically manufactured high-end medical devices. As of September 2025, 22 greenfield medtech projects are operational manufacturing 36-55 device categories including MRI/CT scanners, LINACs, mammography systems, and ultrasound machines, with eligible sales exceeding ₹12,344 crore and growing exports.
- DGFT Revision of SCOMET List – Category 7 for Emerging Technologies (effective ~23 October 2025): Notification No. 31/2025-26 dated 23 September 2025 adds Category 7 to the SCOMET list, bringing advanced semiconductors, quantum technologies, cryogenic systems, additive manufacturing, and related software under export-control licensing. This aligns India’s controls with multilateral regimes and creates new compliance obligations for exporters in strategic tech sectors.
- GFR / GeM Procurement Reforms for Scientific Equipment (effective June 2025): The Ministry of Finance doubled ceilings for direct purchases of scientific instruments and consumables from ₹1 lakh to ₹2 lakh without quotations, raised purchase-committee powers to ~₹25 lakh, and allows VCs/directors to approve global tenders up to ₹200 crore, while permitting non-GeM procurement for specialised research equipment. This speeds up research procurement and reduces administrative delays in universities, national labs, and medical research institutes.
- ESTIC 2025 – Emerging Science, Technology and Innovation Conclave (held 3 November 2025, Bharat Mandapam): ESTIC 2025 served as the launch platform for the ₹1 lakh crore RDI Scheme, with participation from policymakers, industry, and global thought leaders focusing on Viksit Bharat 2047 and high-tech innovation pathways. It signals long-term government commitment to R&D-heavy sectors – biotech, materials, precision engineering, and digital health – all strong demand drivers for advanced scientific, lab, and testing equipment.
- ClinLab India Conference 2026 – Building Diagnostic Resilience (held alongside Medical Fair India, 29-31 January 2026): The 7th ClinLab India conference, themed “Building Diagnostic Resilience: Strengthening India’s Supply Chain,” focused on import substitution, domestic IVD manufacturing, and supply-chain robustness across biotechnology, precision engineering, AI, and cold chain. It highlights the policy and industry push to localise diagnostics manufacturing, creating demand for analyzers, reagents, cleanroom equipment, and quality-control instruments.
- Promotion of Medical Device Parks & Gujarat Medical Device Park at Nagalpar: The central scheme provides up to ₹100 crore per park to four states (UP, Tamil Nadu, Madhya Pradesh, Himachal Pradesh) for common testing and infrastructure facilities. Gujarat has independently allocated ₹250 crore to build a 336-acre medical device park at Nagalpar near Rajkot, expected to host ~400 medtech companies and attract US$100-150 million in investments – both the central parks and Nagalpar will create concentrated demand for lab instruments, QA equipment, process machinery, and construction-testing devices.
- MSME Procurement and Marketing Support (PMS) Scheme – Trade Fair Support (ongoing via MyMSME portal): The PMS Scheme provides financial assistance for MSMEs to participate in domestic and international trade fairs and exhibitions, vendor development programmes, and packaging workshops. Components explicitly include support for domestic trade fairs/exhibitions and international trade fairs, enabling smaller SIDMA-member manufacturers and dealers to subsidise participation in key expos such as Medical Fair India, analytica Lab India, PharmaTech Expo, and WHX Dubai.
- BIS Standards Drive – 214 Critical Medical Devices by December 2025: BIS is developing and updating standards for 214 critical medical devices in addition to over 1,700 healthcare standards already published, with ~1,200 directly applicable to medical devices. The programme prioritises life-saving and diagnostic equipment (ventilators, dialysis machines, imaging systems, implants), assistive technologies, and new standards for dental instruments, respiratory devices, and ophthalmic implants notified in April 2025 – as BIS standards become embedded in CDSCO evaluations and public procurement, OEMs and dealers must ensure equipment meets relevant IS/ISO/IEC benchmarks.
- ICMED 13485 & ICMED 13485 Plus – Voluntary Quality Certification for Medical Devices (active, promoted through 2025): ICMED 13485 is a voluntary Indian quality-management certification scheme aligned with ISO 13485 but adding India-specific regulatory and performance requirements, while ICMED 13485 Plus integrates QMS with product-level performance and safety validation. Intertek, UL India, and other accredited bodies certify manufacturers; for export and government procurement, ICMED marks are increasingly used as quality differentiators for devices in imaging, diagnostics, and surgical instruments.
Actionable Policy Table
| Policy / Reform | What It Does | Why It Matters in the Next 60 Days | Key Action for SIDMA Members |
| Draft MDR Amendment G.S.R. 883(E) – Perpetual Licences + MD-44 Form | Proposes perpetual validity for device manufacturing/import licences; introduces new test & evaluation reporting form MD-44; tightens post-market surveillance | Stakeholder consultation window closed January 2026 – final rules likely to be notified soon; MD-44 reporting will affect all importers and domestic manufacturers | Review your existing MD-5, MD-6, MD-9, MD-10 licence expiry dates and plan for the transition to perpetual licensing; prepare MD-44 compliant test & evaluation documentation frameworks for product lines now |
| SCOMET Category 7 – Quantum, Semiconductors, Cryogenic, Additive Manufacturing | New export-control category effective since ~Oct 2025 covering advanced semiconductors, quantum tech, cryogenic systems, and additive manufacturing equipment | Any export of high-end analytical, cryogenic lab, quantum measurement, or additive manufacturing equipment since October 2025 may have required a SCOMET licence – retroactive compliance review is urgent | Audit all export invoices since Oct 2025 for potentially controlled items under Category 7; check at www.dgft.gov.in; obtain retroactive or prospective licences as needed before next shipment |
| GFR Amendment – Raised Procurement Limits for Scientific Ministries | Direct purchase limit doubled to ₹2 lakh; committee limit raised to ₹25 lakh; GTE authority to ₹200 crore; non-GeM purchases permitted for specialised equipment | R&D institutions are actively purchasing under the new limits; purchase cycles have shortened significantly | Deliver GFR-compliant product catalogues personally to DST, ICMR, ICAR, DRDO, DBT purchase offices this month; flag items under ₹2 lakh for direct-purchase eligibility |
| PLI Medical Devices – Final Operational Year (FY 2026-27) | ₹3,420 crore scheme; 22+ greenfield projects operational; 36-55 device categories now manufactured domestically | PLI-funded facilities (MRI, CT, LINAC, mammography, ultrasound) are in production ramp-up and need calibration and QC support in their final PLI year | Target PLI-commissioned manufacturers with calibration, validation, and QA instrument packages; use DoP’s published list of commissioned greenfield projects to identify hot prospects |
| RDI Fund – ₹1 Lakh Crore (₹20,000 crore FY 2025-26 tranche) | Long-tenure low-interest R&D financing; managed by ANRF/DST; targets biotech, pharma, AI, quantum, energy, 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; track ANRF project approval announcements; initiate relationships with newly funded Focused Research Organisations before RFPs are issued |
| Medical Device Parks – UP, TN, MP, HP (central) + Gujarat Nagalpar (₹250 crore) | Central parks: up to ₹100 crore each; Gujarat Nagalpar: 336 acres, ~400 companies, US$100-150 million investment target | Parks are in build-out and early operations phases – shared testing, QA, and validation infrastructure procurement is active | Contact park management authorities (YEIDA UP, Tamil Nadu TIDCO, Gujarat iCreate/Nagalpar) for preferred vendor listings; position QA, lab, calibration, and construction-testing instruments for common facility contracts |
| MSME PMS Scheme – Trade Fair Financial Assistance | Financial assistance for MSMEs to participate in domestic and international trade fairs and exhibitions | analytica Lab India Mumbai (Apr 22-24), Medicall Hyderabad (Apr 4-6), and PharmaTech Chandigarh (Apr 9-11) are all within or near the application window for current-year PMS support | Apply immediately at my.msme.gov.in for PMS trade fair support for April events; eligibility requires advance application – missed applications cannot be filed retroactively after the event |
| BIS 214 Device Standards Programme (target completion Dec 2025) | 214 new or updated standards for critical medical devices; 16 new standards effective Apr 2025 with 6-month transition | BIS standards are now embedded in CDSCO evaluations and public procurement responses; non-compliant products lose tendering eligibility | Verify all products in portfolio comply with applicable BIS standards; update product test reports and technical documentation; identify NABL-accredited labs for any missing conformance certificates |
| ICMED 13485 Certification | ISO 13485-aligned voluntary Indian quality certification; accepted in government procurement and export markets | MENA and Southeast Asia export buyers met at DUPHAT Dubai (Mar 24-26) are requesting ICMED proof – having it ready supports immediate follow-up | Initiate ICMED 13485 application via NABCB-accredited bodies (Intertek, UL India) if not yet certified; use post-DUPHAT buyer enquiries as the concrete business driver for the application |
| ClinLab India Conference – Import Substitution Push for IVDs | Industry + government focus on localising IVD manufacturing and strengthening diagnostics supply chain | Government and buyer preference for domestically manufactured IVDs is increasing; foreign IVD importers must prepare to compete against locally made alternatives | Identify which IVD products in your portfolio face import-substitution risk; engage with Indian IVD manufacturers for potential co-branding, distribution, or assembly partnerships to maintain market position |
Disclaimer: Policy details are current as of 22 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) | MyMSME (www.my.msme.gov.in) | DoP (www.pharmaceuticals.gov.in).