GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- Union Budget 2026-27 – Healthcare & Pharma Highlights (1 Feb 2026): The Union Budget introduced BCD exemptions on 17 cancer drugs, duty waivers for rare disease personal imports, and a Rs.10,000 crore Biopharma Shakti initiative for biologics manufacturing. A unified digital platform for drug and medical device cargo clearances was announced, alongside a 6%+ increase in the Health Ministry’s allocation to Rs.1.05 lakh crore.
- CDSCO Medical Device Classification Update 2026: CDSCO has reclassified 553 medical devices (351 cardiovascular + 202 neurological) under a risk-based A/B/C/D framework, and issued draft guidance for Software as Medical Device (SaMD/SiMD). AI-powered diagnostic tools and health monitoring apps with clinical claims now fall under stricter vigilance reporting, and Market Standing Certificates (MSC) and Non-Conviction Certificates (NCC) are fully digitalized from April 2025.
- PLI Scheme for Medical Devices (ongoing through FY 2026-27): Government outlay of Rs.3,420 crore has seen 26 applicants invest Rs.852 crore (64% of committed Rs.1,330 crore), with 14 projects commissioned covering cancer care, radiology/imaging, anaesthetics, and pacemakers. MRI, CT, and radiotherapy equipment are now being locally manufactured, and four medical device parks are operational across UP, Tamil Nadu, Madhya Pradesh, and Himachal Pradesh.
- National Medical Devices Policy 2023 – Implementation Phase (ongoing 2025-26): India is implementing harmonized IMDRF-aligned standards, a single-window clearance portal (integrating CDSCO, BIS, AERB, MeitY, DAHD), and a Unique Device Identifier (UDI) system with post-market surveillance. Risk-based import quality surveillance from September 2024 applies random sampling for most devices, with stricter scrutiny for IVDs and diagnostics. The MedTech Mitra platform (ICMR + CDSCO) now provides one-stop clinical validation, regulatory guidance, and funding linkages for innovators.
- UCMPMD – Uniform Code for Marketing Practices in Medical Devices (launched 2025): India’s first dedicated code regulating the promotion and advertising of medical devices, launched by the Department of Pharmaceuticals. It addresses promotional practices previously governed indirectly under the Drugs & Cosmetics Act and creates new compliance requirements for manufacturers and importers.
- NCSTC 2026 – National Conference on Strategic Trade Controls (15 Jan 2026, PAST): The 3rd annual conference organized by DGFT, MEA, and FIEO was attended by 500+ participants including industry, academia, and international delegations. The 3rd Edition Handbook on India’s Strategic Trade Control System was released. The event covered the SCOMET framework, AEO programme, Intangible Technology Transfer (ITT), and updated guidance on dual-use goods across electronics/IT/semiconductors, chemicals/biotech, aerospace/space, defence, quantum/AI, and additive manufacturing.
- Advantage Healthcare India (AHCI) 2026 (23-25 Feb 2026, PAST): A government-backed event organized by the Department of Commerce and multiple export promotion councils (EPCMD, Pharmexcil, EEPC, SEPC, Ayushexcil) to promote India as a premier global healthcare destination. Positioned as an export-promotion platform for medical services, medical devices, and pharma.
Funding Schemes & Support Programs
- RDI Fund (Rs.1 lakh crore): Private sector R&D catalyst – direct demand for scientific instruments in funded projects across quantum, AI, energy, space, and deep tech sectors.
- PLI for Medical Devices (Rs.3,420 crore, through FY 2026-27): Ongoing final year; manufacturers scaling up need QC & testing equipment. Post-PLI sustainability assessment required as scheme concludes.
- Medical Device Parks (4 states operational – UP, Tamil Nadu, MP, Himachal Pradesh): Shared testing/validation infrastructure = shared equipment procurement cycles.
- MedTech Mitra (ICMR + CDSCO): Clinical validation support for Indian MedTech startups – creates demand for testing instruments; platform at medtechmitra.icmr.gov.in.
- Biopharma Shakti (Budget 2026-27): Rs.10,000 crore over 5 years – dedicated demand for bioreactors, cell culture systems, bioanalytical instruments.
Industry Standards, Certifications & Trade Classification Updates
- ICMED (Indian Certification for Medical Devices): Quality certification aligning with ISO 13485; growing export compliance requirement for Indian medical device manufacturers.
- CDSCO 2026 Classification Update: New risk-based rules for SaMD/AI diagnostic tools; class A/B/C/D re-assignments for 553 cardiovascular & neurological devices. EMI/EMC testing and biocompatibility requirements for AI-powered devices are now mandatory.
- BIS Certification Acceleration (2025): Faster BIS approvals for medical devices; NABL accreditation required for test labs submitting certification data.
- NABL ISO Mandate: Labs must maintain ISO 17025 accreditation; expansion of authorized IVD test labs (June 2025 update).
- SCOMET List Update (2025-26): New additions covering quantum technologies, advanced computing, and additive manufacturing equipment. All exporters of scientific equipment must verify product classification against the updated list.
- Customs Digitalisation (Budget 2026-27): Unified digital platform for drugs & medical device cargo clearance – reduces import/export friction.
- India-UK Free Trade Partnership 2025: Some segments of government procurement opened to UK suppliers – competitive impact on domestic scientific equipment manufacturers.
Actionable Policy Table
| Policy / Reform | What It Does | Why It Matters in the Next 60 Days | Key Action for SIDMA Members |
| Union Budget 2026-27 – Biopharma Shakti + Cargo Digitalisation | Rs.10,000 crore for biologics manufacturing; unified digital portal for drug/device cargo clearance | Budget provisions are being operationalized now; biotech equipment procurement cycles are beginning | Contact key biotech and biologics manufacturers to position bioreactor, cell culture, and bioanalytical instrument offerings before procurement RFPs go out |
| GFR Amendment – Raised Procurement Limits for Scientific Ministries | Direct purchase limit doubled to Rs.2 lakh; committee limits to Rs.20-25 lakh; tender thresholds to Rs.1 crore | R&D institutions can now procure faster and at higher values without cumbersome tendering – purchase cycles shortening now | Target DST, DSIR, DBT, ICMR, DRDO, ICAR procurement offices with updated catalogues; highlight GFR-compliant direct purchase eligibility for items under Rs.2 lakh |
| CDSCO 2026 Device Classification + SaMD Guidance | 553 devices reclassified; AI/diagnostic software subject to new risk-based rules; EMI/EMC now mandatory for AI devices | Reclassification compliance deadlines are active; manufacturers need testing lab support now | Identify which products in your portfolio are affected by reclassification; book EMI/EMC and biocompatibility testing slots with NABL-accredited labs immediately |
| GST Reduction on Medical Devices to 5% | Uniform 5% GST replaces 12-18% rates; MRP revision required for importers | MRP revisions must be in market; distributors need updated price lists | Verify revised MRPs are updated across all distribution channels; provide distributors with fresh price sheets reflecting 5% GST |
| SCOMET List Update 2025-26 – Quantum, Computing, Additive Manufacturing | New export-controlled categories added covering quantum tech, advanced computing, and additive manufacturing equipment | Exports without correct SCOMET classification may be held at customs – compliance is immediate | Cross-check all high-value analytical, electron microscopy, clean-room, and additive manufacturing exports against the updated SCOMET list; obtain DGFT licences where required |
| RDI Fund – Rs.1 Lakh Crore (first disbursements mid-2026) | Rs.20,000 crore FY 2025-26 tranche for private sector R&D; managed by ANRF | Project approvals expected mid-2026; funded organisations will need lab and scientific equipment | Register on rdifund.anrf.gov.in; track approved project announcements; position scientific instrument offerings to funded organisations before procurement begins |
| PLI Medical Devices – Final Year (FY 2026-27) | PLI scheme closes; commissioned manufacturers scaling QC and compliance operations | Final-year manufacturers need testing, calibration, and quality control instruments before scheme conclusion | Approach PLI-commissioned manufacturers (MRI, CT, imaging, pacemaker facilities) with calibration, QC, and validation instrument packages |
| National Medical Devices Policy – UDI + Single Window Portal | UDI labelling requirement; integrated clearance portal (CDSCO, BIS, AERB, MeitY, DAHD) | UDI compliance is being enforced for new registrations | Ensure all products in the pipeline carry UDI-compliant labels; familiarise teams with the integrated portal for faster import approvals |
| ICMED + BIS Certification (accelerated 2025) | ISO 13485-aligned quality certification; faster BIS approvals; NABL required for test lab submissions | Export clients in regulated markets (Middle East, Southeast Asia) increasingly require ICMED certification | Begin ICMED certification process if not already initiated; identify NABL-accredited test labs for BIS submission support |
Disclaimer: Policy details are current as of 11 March 2026. Legislative updates may have occurred subsequently. 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) for the latest updates.