GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
TLDR; Nothing new from previous blog on Govt. Policies, Reforms and Funding Initiatives. The summary table is attached below.
SUMMARY
- PLI scheme for medical devices (FY 2022-27): 5% incentive on incremental sales, 22 greenfield projects, 19 operational producing high‑end imaging and critical care devices, boosting local manufacturing and component demand.
- Medical Device Parks (UP, MP, TN): subsidised land and shared high‑end facilities (EMI/EMC, sterilisation, biocompatibility, component testing etc.) to lower capex and cluster medtech manufacturing.
- PRIP (Promotion of Research in Pharma‑Medtech): R&D funding for pharma and novel medical devices, including a Centre of Excellence at NIPER Ahmedabad and structured academia-industry collaboration.
- Capacity Building & Skill Development in Medical Devices: 18 projects across IITs, NITs, NIPERs and others to train ~750 high‑tech professionals in device design, production, testing and diagnostics.
- PLI scheme for pharmaceuticals & IVDs: incentive support for key drug and selected IVD products through 2028, encouraging expanded manufacturing and associated lab/QC infrastructure.
- Union Budget 2025‑26 customs measures: removal of seven industrial customs tariff rates plus full BCD exemption for 36 lifesaving medicines, concessional 5% on six more, and duty‑free status for 37 medicines under patient assistance programmes.
- Reported ~25% additional US tariffs on Indian medical devices (effective total ~35%): raises export cost and compels Indian device exporters to reconsider pricing and market‑entry strategies.
- NCSTC 2026 – National Conference on Strategic Trade Controls (15 Jan 2026, New Delhi): DGFT‑led event on STC framework, SCOMET, AEO, ITT and sectoral controls for chemicals, biotech, aerospace, defence, semiconductors and emerging tech, with release of the 3rd STC Handbook.
- DGFT SCOMET outreach (e.g., Chennai, 8 Aug 2025): regional programme to educate exporters on SCOMET classification, CCR portal usage and export‑control compliance duties.
- Annual Medical Device Regulatory & Quality Summit (New Delhi, 2025; 2026 expected): industry conference covering CDSCO and global regulatory updates, EU MDR, quality systems, tariffs and labeling for medical devices.
INDUSTRY STANDARDS, CERTIFICATIONS & REGULATORY CHANGES
| # | Policy/Regulation | Effective Date / Timeline | Issuing Authority | Scope & Coverage | Key Compliance Requirements | Impact on SIDMA Members |
| 1 | SCOMET Category 7 – Emerging Technologies Export Controls | Effective: 2025-10-23 | DGFT (Directorate General of Foreign Trade), Ministry of Commerce & Industry | Advanced semiconductors, quantum technologies, cryogenic systems, fabrication/testing/diagnostic equipment for semiconductors | – Export authorization required for Category 7 items- Classification against sub-categories 7A-7E mandatory- Integration with internal export-control compliance programmes- Software and technical data also covered | HIGH IMPACT– Affects exporters of high-end test, metrology, semiconductor-related lab equipment- Must classify products and obtain licenses where required- Non-compliance risks shipment holds and penalties |
| 2 | Machinery & Electrical Equipment Safety (Omnibus Technical Regulation) Order, 2024 & 2025 Amendment | Original: 2024-08 (notified)Enforcement: 2025-08-28Extended deadline: 2026-09-01 | Ministry of Heavy Industries (Bureau of Indian Standards – BIS) | Mandatory BIS certification (Scheme X) for industrial machinery & electrical equipment: pumps, compressors, centrifuges, cranes, transformers, switchgear, motors, etc.Covers ~50,000 machinery types across 463 tariff | – Mandatory BIS license/Certificate of Conformity (CoC)- Adherence to Type A/B/C safety standards (IS/IEC/ISO)- Product marking with BIS logo- QMS compliance (ISO 9001 or equivalent)- Market surveillance by BIS | VERY HIGH IMPACT– Lab and process instruments incorporating covered machinery (pumps, compressors, centrifuges) must secure BIS certification- Affects both manufacturers and importers- Supply chain disruption risk post-2026-09-01 if components not certified- Coordinate with suppliers on BIS status |
| 3 | CDSCO Draft Guidance on Import Licensing for IVD Medical Devices | Draft released: Early Feb 2026Final guidance: TBD (public consultation phase) | CDSCO (Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare | In-Vitro Diagnostic (IVD) medical devices import licensing under Medical Device Rules (MDR) 2017 | – Clarifies MD-14 (Import License) and MD-16 (Test License) application procedures- Documentation requirements via CDSCO Sugam and NSWS portals- Stricter data quality and labeling expectations | HIGH IMPACT– Directly affects importers/distributors of diagnostic kits and IVD analyzers- SIDMA members as Indian agents for foreign IVD suppliers must update compliance checklists- Clearer pathways reduce uncertainty but tighten approval standards |
| 4 | Medical Device Rules (MDR) 2017 – General Import & Test License Regime | Effective: 2017 (fully operational as standalone framework by 2020)Ongoing: Continuous enforcement | CDSCO, Ministry of Health & Family Welfare | Risk-based classification of all medical devices (Class A, B, C, D); import licenses (MD-14/MD-15) and test licenses (MD-16/MD-17) | – QMS compliance (ISO 13485) mandatory- BIS conformance where applicable- Test licenses specify quantity and site- Movement of devices between sites requires CDSCO notification- Record-keeping and disposal/export of unused samples mandated | VERY HIGH IMPACT– Critical for all SIDMA members importing/manufacturing medical devices or diagnostic equipment- Shapes regulatory expectations for Indian-made devices (domestic and export)- Non-compliance blocks market access |
| 5 | GeM & GFR Procurement Reforms for Scientific Equipment | Circular issued: 2025-06-05Effective: Immediate (FY 2025-26 onwards) | Ministry of Finance (Department of Expenditure) | Specialized research and scientific equipment procurement by government labs, universities, research institutions | – Relaxed mandatory GeM use for specialized/proprietary equipment- Non-GeM procurement allowed where GeM items unsuitable- Direct purchase limit raised from ₹1 lakh to ₹2 lakh– Heads of institutions can approve global tenders up to ₹200 crore– Reduced proof-of-non-availability burden | VERY HIGH POSITIVE IMPACT– Premier institutes/labs can now source higher-quality, proprietary instruments outside GeM- Less red tape for specialized equipment- SIDMA members should proactively educate R&D customers about new flexibilities- Opportunity to compete on quality vs. L1-only basis |
| 6 | Import Duties & Taxes on Lab Chemicals and Equipment | Ongoing adjustments: FY 2025-26 (Union Budget 2025-26)Lab chemical duty hike: Up to 150% on certain imports reported early 2026 | Ministry of Finance (Customs & Indirect Taxes), CBIC | Lab chemicals, reagents, and certain lab equipment (HS codes 84199090, 84198990, etc.) | – Baseline basic customs duty: ~7.5% on certain lab equipment HS codes- Additional social welfare surcharge and IGST apply- Significant duty increases (up to 150%) on specific imported lab chemicals | MEDIUM-HIGH IMPACT– Raises cost of imported reagents and certain equipment- May incentivize local manufacturing/sourcing of lab supplies- Beneficial for domestic suppliers in SIDMA network- Importers face margin pressure; need to review pricing strategies |
| 7 | IMDRF Global Regulatory Convergence Initiatives | IMDRF 29th Session: 2026-03-09 to 2026-03-13 (Singapore)Ongoing: Continuous harmonization efforts | International Medical Device Regulators Forum (IMDRF); India participates via CDSCO | Global medical device standards harmonization, digital health regulatory frameworks, AI in medical devices, cybersecurity, UDI systems | – India adopts IMDRF guidance documents progressively- Future Indian regulations will align with IMDRF standards- Digital health and SaMD (Software as Medical Device) frameworks evolving | MEDIUM-LONG TERM IMPACT– Influences future Indian device regulations and standards harmonization- Affects SIDMA product compliance requirements over time- Watch for IMDRF outputs on digital health, AI, cybersecurity for strategic planning |
| 8 | Union Budget 2025-26 – Customs Duty Rationalization (Health Sector Focus) | Budget date: 2025-02-01Effective: FY 2025-26 | Ministry of Finance | Lifesaving medicines and healthcare products; general industrial goods tariff structure | – 36 lifesaving medicines now fully exempt from Basic Customs Duty- 6 medicines added at 5% concessional duty- 37 more medicines under patient assistance programmes made duty-free- Seven customs tariff rates removed for industrial goods (rationalization) | LOW-MEDIUM DIRECT IMPACT– Primarily drug-focused, but duty structure on lab chemicals/reagents indirectly affects SIDMA lab segment via input costs- Hospital budget savings on medicines may free up capex for equipment- General tariff rationalization improves predictability |