GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES

GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES – Feb 10

Regulatory & Trade‑Compliance Conferences (Implementation Events)

1. NCSTC 2026 – Bharat Mandapam, New Delhi
   1. Covered above – significant policy‑implementation interface between DGFT, CBIC, MEA and exporters.
2. 11th Customs & Trade Compliance India Summit 2026 (Inventicon)
   1. Event: “Customs & Trade Compliance India Summit 2026” (11th edition).
   2. Focus: International trade policy, export control regulations, customs valuation, AEO, duty optimization and FTAs.
   3. Relevance: Important for device and equipment exporters dealing with classification, valuation and multi‑jurisdictional trade controls.
3. 10th Annual Medical Device Regulatory & Quality Summit 2026
   1. Conference dedicated to medical device regulatory compliance, quality systems and global market access, emphasising MDR, global RA/QA strategies, sustainability and marketing codes.
   2. Relevance: Useful for RA/QA and export managers to track CDSCO, EU MDR and global regulatory expectations for devices.
4. Global MedTech Connect (India‑focused medtech regulatory & QA forum)
   1. Examines MedTech QA/RA, risk management, AI‑based device regulation, MDSAP and post‑market surveillance.
   2. Relevance: Strengthens understanding of regulatory pathways for sophisticated devices and diagnostics.

Funding Schemes & Support Programs Relevant to Equipment Trade

1. PLI – Medical Devices: Incentive‑based support for local manufacturing of complex imaging and therapeutic devices; reduces import dependence and boosts OEM collaborations.
2. Medical Device Parks Scheme: Central capital support for shared testing labs, validation centers and infrastructure in 4 states; plus state‑specific parks like UP’s YEIDA Medical Device Park targeting imaging and implant segments.
3. Pharma Innovation Fund (₹1,500 cr) and RDI Scheme (₹1,00,000 cr): Provide long‑term financing and grants/loans to pharma and deep‑tech projects, including medtech, diagnostics, AI in health and biotech manufacturing.
4. Biopharma R&D Scheme: Dedicated schemes to make India a global biopharma hub, supporting advanced biologics, biosimilars and novel med‑device development.

Key Recent Announcements (Approx. Last 6–12 Months)

1. RDI Scheme & Research Development and Innovation Fund (RDIF) – ₹1 lakh crore deep‑tech R&D facility
   • Policy: Union Cabinet approved the Research, Development and Innovation (RDI) Scheme with a ₹1 lakh crore corpus to catalyse private‑sector R&D across strategic technologies.
   • Implementation:
     • RDIF set up as a Special Purpose Fund under ANRF (Anusandhan National Research Foundation).
     • Provides long‑tenor, low/no‑interest loans and equity for high‑TRL projects (TRL≥4) in areas like AI, clean energy, semiconductors, biotech, deep‑tech manufacturing and digital economy.
   • Relevance: Creates a financing channel for advanced medical device, lab equipment and diagnostic technology R&D and scale‑up.
2. Pharma Innovation Fund India 2025 – ₹1,500 crore
   • Policy: Dedicated ₹1,500 crore fund under Department of Pharmaceuticals for pharma and allied life‑science R&D, encouraging new drug discovery, formulation, biotech and API innovation, with explicit preference for Tier II/III city projects.
   • Relevance: Device & instrument makers with drug‑delivery, biotech process or analytical innovations can partner with funded pharma R&D projects.
3. PLI Scheme for Medical Devices – Progress into 2026
   • Design: 5‑year PLI (FY 2022‑23 to FY 2026‑27) with 5% incentives on incremental sales of domestically manufactured medical devices in four target segments (imaging, radiotherapy, anaesthesia & cardio‑respiratory, implants).
   • Outcomes as of late‑2025:
     • 21–22 approved projects commissioned; production started for 54–55 advanced devices (MRI, CT, C‑arm, mammography, LINACs etc.).
     • Cumulative eligible sales ~₹12,344 crore (as of Sept 2025).
   • Relevance: Builds domestic capacity in capital‑intensive imaging and radiotherapy equipment; helps SIDMA members seeking local sourcing and JV opportunities.
4. Medical Device Parks & Cluster Infrastructure
   • Central Scheme: Scheme for Promotion of Medical Devices Parks – ₹400 crore outlay to fund common infrastructure facilities in 4 parks (Himachal Pradesh, Tamil Nadu, Madhya Pradesh, Uttar Pradesh).
   • Example – Uttar Pradesh Medical Device Park (YEIDA):
     • Location: Sector 28, YEIDA (near Noida International Airport).
     • 350‑acre park targeting radiology & imaging, anaesthesia & cardio‑respiratory, implants and nuclear imaging devices.
   • Relevance: Cluster‑based infrastructure (testing labs, shared utilities) will lower manufacturing costs for device OEMs, benefitting SIDMA through stronger domestic product pipelines.
5. Union Budget 2025–26 & 2026–27 – Tariff & Tax Changes Impacting Devices/Labs
   • Customs Duty on Laboratory Chemicals:
     • 2024 hike from 10% to 150% BCD sparked backlash; 2024 notification later capped actual‑user imports at 10% BCD for bonafide lab/R&D use.
     • Budget 2025–26 reduced tariff rate to 70% while imposing additional AIDC; but the 10% concessional rate remains for labs importing under actual‑user conditions.
     • Impact: Commercial importers face higher duties; research institutions can still import most lab chemicals at ~10% if complying with actual‑user undertakings.
   • GST Reduction on Medical Devices & IVDs (September 2025):
     • GST Council reduced GST rates for a list of medical devices, equipment, apparatus and IVDs effective 2025‑09‑22; manufacturers must reduce MRPs and file revised price lists with NPPA.
     • Impact: Lower end‑user prices but margin recalibration; distributors must align tax invoicing and MRP communications.
   • Drugs & Life‑saving Therapies:
     • Budgets 2025–26 and 2026–27 expanded lists of life‑saving medicines exempt from BCD or at concessional 5% rates; while not directly about equipment, this influences overall hospital import mix.
6. Strategic Trade Controls (SCOMET) – NCSTC 2026 Outcomes
   • National Conference on Strategic Trade Controls (NCSTC 2026) was held in New Delhi on 2026‑01‑15, organized by DGFT with MEA, CBIC and others.
   • Focus: Export controls on dual‑use goods and technologies under SCOMET, including specialized chemicals, biotech equipment, aerospace/space hardware, defence and high‑end electronics.
   • Key outcome: Release of the third edition of the Handbook on India’s Strategic Trade Control System, clarifying licensing procedures, compliance expectations and enforcement.
   • Relevance: For SIDMA members exporting high‑end lab, biotech, imaging or dual‑use measurement equipment, SCOMET classification and licensing obligations become increasingly central to export strategy.

Procurement, Export & Documentation Reforms

1. GFR & GeM Procurement Reforms for Research & Labs (June 2025)
   • Finance Ministry circular (June 2025) and GFR revisions allow designated scientific institutions (DST, DBT, CSIR, ICMR, ICAR, DAE, Space & PG research institutions) to:
     • Bypass GeM for specialized scientific equipment and consumables.
     • Have institutional heads approve Global Tender Enquiries up to ₹200 crore.
     • Use higher thresholds for direct purchase and local purchase committee procurement (₹2 lakh and ₹25 lakh respectively).
   • Relevance: Facilitates procurement of high‑end scientific instruments and custom lab systems, easing business with R&D customers.
2. CDSCO Digitalization & Neutral Export Codes
   • Neutral Code for Exports (April 2025): CDSCO introduced auto‑generated “Neutral Code” for exports under MDR 2017, enabling device manufacturers to generate codes directly from their online dashboard for export documentation, replacing manual issuance.
   • Subsequent Importer Mechanism (September 2025): New online route to allow “subsequent importers” to register for devices already approved under MDR 2017, avoiding duplicate approvals and simplifying supply‑chain structures.
   • Additional guidance: Draft guidance on import of IVDs via CDSCO/NSWS portals; updated FAQs and addenda clarifying device classification, licensing, and post‑approval changes.
   • Relevance: Reduces friction for import‑based distributors and exporters, streamlines multi‑importer models and simplifies regulatory documentation.
3. Laboratory Chemicals Duty Saga
   • BCD on lab chemicals briefly hiked to 150% in Union Budget 2024–25, then effectively rolled back for actual‑user labs via a concessional 10% route and later re‑calibrated in Budget 2025–26 (tariff cut to 70% plus AIDC, but concessional channel retained).
   • Relevance: Labs importing small‑volume high‑purity chemicals retain access to manageable duty rates, sustaining instrument utilization and test capacity.
4. International Tariff Dynamics Impacting Indian Device Exports
   • US tariffs on Indian medical devices (2025): Reports of new 25% US tariffs on Indian medical devices, raising effective tariff to ~35% when combined with base duties on some lines; however, relative advantage versus Chinese devices (who may face >50% tariffs) could preserve some competitiveness.
   • Relevance: Export‑oriented SIDMA members targeting US markets must re‑evaluate pricing, origin strategies and FTA‑linked supply chains.

QUICK-WIN OPPORTUNITIES (Policy-Driven)

Opportunity	Policy Driver	SIDMA Member Action	Timeline	Expected Benefit
Target R&D Labs with Custom Equipment	GFR relaxation – labs can bypass GeM for specialized equipment up to ₹200 crore GTEs	✅ Map DST/DBT/CSIR/ICMR labs; offer turnkey/custom solutions	Immediate	Faster procurement cycles; higher-value orders
Apply for RDI Fund (Device Scale-Up)	₹1 lakh crore RDI Fund for deep-tech R&D (TRL ≥4)	✅ Identify device/technology ready for scale-up; prepare business plan	Q1-Q2 2026 (portal open)	Low-interest loans/equity for manufacturing pilots
Partner with PLI-Approved Manufacturers	PLI – Medical Devices creating domestic capacity in imaging, radiotherapy	✅ Offer component supply, testing services, calibration to PLI beneficiaries	Ongoing	Stable domestic customer base; reduced import competition
Export via India Pavilions	Pharmexcil/EEPC/FIEO organizing subsidized pavilions at WHX Dubai, MEDICA, CPhI	✅ Register for government-supported export pavilions	Deadlines 3-6 months before expo	50-70% cost subsidy on booth, travel, marketing
Leverage Medical Device Park Infrastructure	4 Medical Device Parks with shared testing/calibration labs	✅ Contact park authorities (HP, TN, MP, UP) for co-location, testing facility access	Ongoing	Reduced capex for testing/validation; cluster networking
Educate Lab Customers on Chemical Duty Savings	10% BCD concessional route for actual-user labs (vs. 70% commercial)	✅ Create compliance guides for customers; assist with actual-user documentation	Immediate	Competitive edge – help labs reduce reagent costs; strengthen customer loyalty