GOVERNMENT POLICIES, REFORMS & FUNDING INITIATIVES
Policy Summaries
- CDSCO Draft Guidance on Import of IVD Medical Devices (released 30 January 2026): CDSCO circulated a comprehensive draft guidance describing documentation, stability and analytical-performance data required for IVD imports via its digital portals, with a risk-based approach and high-risk categories (HIV, HBV, HCV, cancer, TB IVDs) requiring Indian laboratory performance-evaluation reports. The draft clarifies roles of the Central Licensing Authority and documentation for Drug Master Files.
- Customs Duty Rationalisation – Lab Chemicals & Life-Saving Drugs (Budgets 2024-25 and 2025-26): An initial steep hike in basic customs duty on imported laboratory chemicals (from 10% to 150%) triggered severe industry pushback, leading to subsequent rollbacks and concessional structures; later rationalised to 70% BCD plus AIDC with specific concessions for own-use research chemicals. Separately, the 2025-26 and 2026-27 budgets expanded the list of life-saving drugs fully or partially exempt from BCD, including 17 cancer drugs, easing costs for oncology and rare-disease medicines.
- NCSTC 2026 – National Conference on Strategic Trade Controls (held January 2026): DGFT, MEA and FIEO convened government, industry, academia and international partners to discuss India’s strategic-trade-control system covering dual-use exports under SCOMET, licensing, enforcement and supply-chain security. The third edition of the “Handbook on India’s Strategic Trade Control System” was released, structuring guidance for exporters of sensitive items.
- PLI Scheme for Domestic Manufacturing of Medical Devices (FY 2022-23 to FY 2026-27): With a total outlay of ₹3,420 crore, the scheme offers 5% incentives on incremental sales of domestically manufactured medical devices over five years. By late 2025, 22 greenfield projects had been commissioned and production commenced for >55 devices including MRI, CT, mammography, C-arm X-ray, ultrasound and LINAC systems, directly expanding the installed base and aftermarket demand for QC instruments, calibration tools and related equipment.
- PLI Schemes for Pharmaceuticals (APIs/KSMs and Formulations) – Deadline Extensions: PLI schemes supporting domestic production of APIs, KSMs and high-value formulations – with combined outlays of ₹15,000 crore for finished drugs and ₹6,940 crore for bulk-drug raw materials – had application deadlines extended to July 2025 and January 2026 respectively to accommodate more projects. Intensified domestic pharma manufacturing over 2025-27 will raise demand for process control equipment, cleanroom systems, filtration, lab instruments and QA/QC infrastructure.
Actionable Policy Table
| Policy / Reform | What It Does | Why It Matters in the Next 60 Days | Key Action for SIDMA Members |
| GFR Amendment – Raised Procurement Limits for Scientific Ministries | Direct purchase limit doubled to ₹2 lakh; committee limit raised to ₹25 lakh; tender threshold to ₹1 crore; GTE authority to ₹200 crore | R&D institutions are actively procuring under the new limits right now – purchase cycles have shortened | Call on DST, DSIR, DBT, ICMR, DRDO, ICAR purchase offices immediately with GFR-compliant catalogues; highlight direct-purchase eligibility for items under ₹2 lakh |
| Updated SCOMET List 2025 – Quantum, Computing, Additive Manufacturing | New export-controlled categories: quantum tech, advanced computing, additive manufacturing equipment | Exports without DGFT licence for newly controlled items will be held at customs | Cross-check all high-value analytical, imaging, clean-room and additive manufacturing exports against the updated SCOMET list at www.dgft.gov.in; obtain licences before next shipment |
| CDSCO Online Risk Classification Portal + Oncology Device List | Manufacturers/importers can pre-validate device class (A-D) online before filing licence | Oncology device classification rules are now in force; AI diagnostic tools and SaMD require risk classification before CDSCO submission | Log in to cdscomdonline.gov.in and classify all unclassified devices in your portfolio now, especially oncology, AI diagnostic and SaMD products, before your next licence or import filing |
| CDSCO Draft Guidance – IVD Import (released 30 Jan 2026) | Codifies documentation, performance data and Indian lab evaluation requirements for IVD imports | Draft is in consultation; submissions from industry close shortly – companies without IVD import strategies will be caught off-guard when guidance is finalised | Review the draft guidance at CDSCO portal; identify which IVD products need Indian lab performance-evaluation reports; initiate lab partnerships for high-risk IVDs (HIV, HBV, HCV, cancer, TB) now |
| Customs Duty Rationalisation – Lab Chemicals | Initial 150% BCD hike on imported lab chemicals partially rolled back; final structure 70% BCD + AIDC with concessions for own-use research chemicals | Price adjustments for lab chemical imports need to be reflected in current quotes and contracts | Review all active import orders and customer quotes involving lab chemicals; confirm applicable duty rate (concessional own-use vs commercial); update price sheets and contracts accordingly |
| PLI Medical Devices – Final Year (FY 2026-27) | ₹3,420 crore scheme concludes this year; 22+ greenfield projects now commissioning | PLI-funded facilities (MRI, CT, ultrasound, LINAC) are scaling QC and compliance operations in their final PLI year | Approach PLI-commissioned manufacturers with calibration, QC instruments and validation equipment packages; use PLI facility lists published by DoP to identify prospects |
| PLI Pharmaceuticals – Extended Deadlines | API and formulation PLI applications accepted through Jan 2026; production scaling from 2026 | New PLI-funded API/KSM plants will require process control, cleanroom, and QA/QC equipment as they ramp up | Identify newly onboarded PLI pharma projects via Department of Pharmaceuticals notifications; initiate early equipment supply conversations before procurement RFPs are issued |
| Medical Device Parks – UP, TN, MP, HP | Up to ₹100 crore central grant per park; 4 parks in build-out/early operation | Parks are actively procuring shared testing and validation infrastructure | Contact park management authorities (especially YEIDA in UP) for preferred vendor listings and equipment supply opportunities; position QA, lab and construction-testing instruments |
| RDI Fund – ₹1 Lakh Crore (first disbursements mid-2026) | ₹20,000 crore first tranche; targets quantum, AI, energy, deep tech; private sector co-investment required | First project approvals expected mid-2026; funded organisations will need lab and scientific equipment immediately | Register on rdifund.anrf.gov.in; monitor ANRF announcements for approved Focused Research Organisations; contact funded entities early – procurement follows disbursement quickly |
| BIS 214 Device Standards + 16 New Standards (transition deadline Oct 2025) | 214 new device standards under development; 16 new standards effective Apr 2025; older versions being phased out | BIS standards are now used in CDSCO evaluations and public procurement decisions | Verify all devices in portfolio comply with applicable current BIS standards; update test reports and design documentation before next product submission or tender response |
| ICMED 13485 Certification | ISO 13485-aligned voluntary certification with India-specific requirements; increasingly required for export and government supply | MENA and Southeast Asia export buyers (post-WHX Dubai, post-DUPHAT) are requesting ICMED proof | Initiate ICMED 13485 application via NABCB or accredited bodies (Intertek, UL India) if not yet certified; use DUPHAT and WHX follow-up buyer meetings as the deadline driver |
Disclaimer: Policy details are current as of 16 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) | DoP (www.pharmaceuticals.gov.in).