GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- PLI Scheme for Medical Devices – Progress & FY 2026 Outlook (ongoing FY 2022-23 to FY 2026-27): With a total outlay of ₹3,420 crore, the scheme offers 5% incentives on incremental sales across four high-import segments – cancer care/radiotherapy, radiology & imaging, anaesthetics & cardio-respiratory devices, and implants. By September 2025, 22 greenfield projects were commissioned and production had started for 55+ devices including MRI, CT, mammography, C-arm, ultrasound, MRI coils, and LINACs, with eligible sales reaching ~₹12,344 crore – structurally increasing B2B demand for QC equipment, calibration tools, and lab testing infrastructure.
- Scheme for Strengthening of Medical Device Industry (SMDI) – ₹500 Crore (launched 8 November 2024; proposals invited January 2026): Total outlay of ₹500 crore over three years (FY 2024-25 to FY 2026-27) with sub-schemes for common testing facilities in device clusters, skill development, marginal-investment support, and promotional activities. January 2026 call for proposals seeks applications for common testing and evaluation facilities in device clusters – creating publicly supported testing labs that will need advanced lab and testing equipment and simultaneously raise compliance baselines.
- CDSCO Medical Device Regulatory Updates – Risk Reclassification & Software Guidance (2025-2026): 553 cardiovascular and neurological devices re-classified across risk classes A–D (large share in Class D), aligning with IMDRF and MDR 2017 framework. A new 76-page draft guidance (issued 21 October 2025) brings clarity on scope, definitions, classification, QMS, and technical documentation for Medical Device Software and SaMD/IVD software. The CDSCO online portal was updated (December 2025) to handle new risk classification workflows.
- NCSTC 2026 – National Conference on Strategic Trade Controls (held 15 January 2026, Bharat Mandapam / Vigyan Bhawan): DGFT in collaboration with MEA, FIEO, and other agencies convened sector-specific sessions on SCOMET policy, licensing, enforcement, and compliance for dual-use technology exporters. Focused on emerging technologies – quantum, advanced computing, semiconductors, additive manufacturing, cyber-security – and their export-control implications, with the third edition of the Handbook on India’s Strategic Trade Control System released.
- Medical Device Regulatory & Quality Summit 2026 – 10th Annual Edition (dates TBD): Private conference focusing on tariff headwinds for Indian device exporters, changes in MDR/EU MDR, evolving device regulations, and quality/patient safety requirements. Provides a forum for regulators and industry leaders to discuss compliance, testing, and export issues for devices – attending or tracking outputs gives direct guidance on regulatory-driven feature and documentation requirements.
- Pharmexcil Chintan Shivir – “Scaling Up Pharma Exports” (held 4 April 2026, Hyderabad): High-level closed-door strategy meeting on export growth, trade barriers, and policy support for India’s pharma exporters. Shapes export priorities and bottlenecks for pharma plants, which drive demand for new production, QC, and lab equipment. Track follow-up PHARMEXCIL circulars on export constraints that can affect machinery and instrument procurement.
- Workshops on SMDI Scheme – NIPER Hyderabad (held 20 February 2026): Workshop by Department of Pharmaceuticals & Life Sciences Skill Development Council explaining scheme structure, eligibility, and application process for cluster common-facilities and capacity-building in medical devices. Targets manufacturers and cluster entities seeking funding for testing labs, shared infrastructure, and skill development.
- Chintan Shivir + Technical Meet on ZLD/Wastewater Treatment (Hyderabad, March 2026): PHARMEXCIL-hosted technical meeting on Design & Operational Strategies for Sustainable Wastewater Treatment & ZLD Systems for pharma clusters. Wastewater and ZLD compliance drives new monitoring, lab testing, and process-control equipment purchases; export strategy discussions influence capital planning for new facilities.
Actionable Policy Table
| Policy / Reform | What It Does | Why It Matters in the Next 60 Days | Key Action for SIDMA Members |
| PLI Medical Devices – Final Operational Year (FY 2026-27) | 22 greenfield projects in production; 55+ device categories commissioned; eligible sales ₹12,344 crore | PLI-funded facilities (MRI, CT, LINAC, mammography, ultrasound) are in active production ramp-up and need calibration and QC instruments now – this window closes when PLI ends | Contact PLI-commissioned manufacturers from DoP project list in April–May before their first full-year production audit; pitch calibration, QA, and validation instrument packages |
| SMDI Scheme – ₹500 Crore (proposals accepted; cluster lab funding active) | ₹500 crore for common testing labs and cluster infrastructure in device clusters; January 2026 proposals under review | Approved clusters will begin procuring shared testing and validation equipment in Q2 2026 | Contact SMDI-eligible clusters and device parks (Greater Noida, Kanchipuram, Ujjain) about preferred vendor listing for lab instruments and testing equipment in their common facilities |
| GFR Amendment – Raised Limits for Scientific Institutions | Non-GeM procurement allowed; direct purchase to ₹2 lakh; committee to ₹25 lakh; GTE to ₹200 crore | Active procurement cycle is underway at CSIR, ICMR, IITs, ICAR, DRDO – institutes can buy faster and at higher values | Deliver GFR-compliant direct-purchase catalogues to DST, ICMR, ICAR, DRDO, DBT purchase officers this month; flag items under ₹2 lakh for instant direct-purchase eligibility |
| SCOMET Category 7 – Advanced Semiconductors, Quantum, Cryogenic, Additive Manufacturing | New export controls effective 23 Oct 2025; DGFT licence required for listed items | Retroactive compliance exposure for any shipments since Oct 2025 of potentially controlled items | Audit export shipments since 23 Oct 2025 at www.dgft.gov.in; obtain retroactive and prospective licences; train teams on NCSTC Handbook Category 7 classification |
| CDSCO Risk Reclassification – 553 Cardiovascular/Neurological Devices | Devices re-classified A–D under MDR 2017; online classification module active since Dec 2025 | CDSCO submissions without correct risk class are being rejected; reclassification needed before any filing | Log in to cdscomdonline.gov.in; reclassify all cardiovascular, neurological, and AI/SaMD products before the next import or manufacturing licence filing |
| CDSCO SaMD / Software Guidance – 76-Page Draft | Scope, classification, QMS, and technical documentation requirements for Medical Device Software | CDSCO is applying SaMD guidance in current review cycles – AI diagnostic and cloud-connected lab systems need updated technical files | Review and update technical documentation for all software-enabled or AI-driven devices in portfolio; engage regulatory consultant to align submissions with the new guidance |
| RDI Fund – ₹1 Lakh Crore (₹4,000 crore initial disbursements in early 2026) | Long-tenure low-interest R&D financing; TDB and BIRAC are first fund managers; targets biotech, pharma, AI, quantum | First project approvals translating to equipment procurement; funded entities are moving to instrument acquisition phase | Register vendor interest on rdifund.anrf.gov.in; track ANRF/TDB/BIRAC project approvals; position advanced analytical, lab automation, and testing instruments early with newly funded projects |
| Pharmexcil Chintan Shivir Follow-up – Export Strategy Circulars | Closed-door policy meet (Apr 4) shapes Pharmexcil’s export support priorities and upcoming scheme notifications | Follow-up circulars expected within 2–3 weeks; will outline new export incentives, NTB redressal, and logistics support | Subscribe to PHARMEXCIL circular updates at pharmexcil.com; monitor for announcements on export support schemes, new market access opportunities, and logistics facilitation – these will influence your export-focused equipment supply pipeline |
Disclaimer: Policy details are current as of 5 April 2026. Cross-reference with: DGFT (www.dgft.gov.in) | CDSCO (www.cdscomdonline.gov.in) | DST/RDI (www.rdifund.anrf.gov.in) | BIS (www.bis.gov.in) | PHARMEXCIL (www.pharmexcil.com) | DoP (www.pharmaceuticals.gov.in).