Policy Summaries

• Draft Medical Devices Rules Amendment 2026 – G.S.R. 270(E) (draft notified 10 April 2026): This amendment introduces a formal definition for Certificate of Registration, mandates labelling of outsourced sterilisation site licence numbers, and adds a new Ninth Schedule specifying fees for testing and evaluation at government and designated testing laboratories. The 30-day consultation window has now closed and final gazette notification is imminent, directly affecting compliance timelines and cost planning for sterile medical device manufacturers and importers.
• PLI Scheme for Medical Devices (ongoing FY 2020-21 to FY 2027-28): Thirty-two applicants were selected; 19 greenfield projects have been commissioned for 44 high-end products including linear accelerators, MRI machines, CT scanners, mammography systems, C-arms, ultrasound and X-ray equipment. The scheme has realised over ₹1,057 crore of the committed ₹1,356.94 crore investment and generated cumulative sales of approximately ₹8,039 crore, including exports of approximately ₹3,844 crore.
• PLI Scheme for Pharmaceuticals (ongoing FY 2022-23 to FY 2027-28): With a financial outlay of ₹15,000 crore, this scheme supports value-added pharma products including complex generics, biopharmaceuticals and in-vitro diagnostic devices, driving investments exceeding ₹33,500 crore by October 2024 across 45 companies, with incentive payouts of ₹3,215 crore already made. It fuels capex and capacity expansion in pharma and diagnostics manufacturing, generating sustained demand for process equipment, QC instruments, lab automation and cleanroom infrastructure.
• Scheme for Promotion of Medical Device Parks: The scheme provides up to ₹100 crore per park, covering 70-90% of common-infrastructure costs, for four approved medical device parks in Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal Pradesh, with a total outlay of ₹400 crore. These parks create shared testing, manufacturing and R&D infrastructure that reduces per-unit production costs and generates sustained demand for test and calibration labs, cleanroom equipment, process validation instruments and QA systems.
• National Conference on Strategic Trade Controls (NCSTC) 2025 and 2026: This two-day conference series on SCOMET and export controls brings together 550-600 participants from government, industry and foreign delegations to discuss sector-specific compliance for electronics and IT, biotechnology, chemicals, aerospace and defence. The 2025 and 2026 editions emphasised IT-enabled licensing, industry outreach and release of an updated Strategic Trade Control Handbook; SIDMA members exporting sensitive equipment should monitor and attend future editions.
• SCOMET Sector Outreach Programs (IT, Aerospace and Others; 2025-2026): Targeted SCOMET outreach events have been held with sector-specific focus, explaining export-control obligations and internal compliance programme design. While some outreach is sector-specific, the methodology and compliance expectations extend fully to scientific and lab equipment exporters; SIDMA companies can adapt these templates to design internal compliance programmes for dual-use product lines.
• State-Level Assistance to R&D Laboratories – Gujarat (active 2026): The Gujarat government’s Scheme for Assistance for Research and Development Activities (SARDARDL on myScheme portal) provides financial assistance to state-backed R&D institutions for equipment acquisition and lab infrastructure investment. Eligible Gujarat institutions are in active procurement cycles for lab instruments and infrastructure, creating a pipeline of buyers for SIDMA analytical and prototyping instruments.
• Pharma Regulatory Summit 2026 (9th Annual; held March 2026, Mumbai): This annual conference focused on regulatory strategy in a dynamic pharma landscape, with sessions on CDSCO updates, global regulatory trends, quality, compliance, equipment validation, data integrity and GMP for equipment-intensive operations. Useful reference for pharma-equipment suppliers to understand how client regulatory expectations shape equipment design, documentation, validation and lifecycle support requirements.

Actionable Policy Table

Policy / Reform	What It Does	Why It Matters in the Next 60 Days	Key Action for SIDMA Members
CDSCO Oncology Device Risk Classification (January 2026)	Classifies 77 oncology devices into risk classes under MDR 2017; part of the 1,178-device classification programme	Classification directly determines registration, import licensing and distribution requirements for oncology equipment	Confirm correct risk class for all oncology-related products in your portfolio; update import licences and registration files accordingly; consult CDSCO’s published classification notification
PLI Scheme – Pharmaceuticals (₹15,000 crore outlay; ₹33,500+ crore investments)	Supports pharma capacity expansion including biopharmaceuticals and IVD devices; 45 companies incentivised	Funded pharma companies are commissioning new manufacturing lines requiring process equipment, QC instruments and cleanroom infrastructure	Identify PLI-funded pharmaceutical companies via DoP project lists; target process equipment, lab automation and QC instrument proposals during their line-commissioning phases
GFR Amendment – Non-GeM Procurement; Direct Purchase to ₹2 lakh; GTE to ₹200 crore	Removes GeM-only constraint for quality-critical research equipment; doubles direct-purchase and committee limits; new global tender authority for institution heads	Active procurement cycle at CSIR, ICMR, IITs, ICAR, DRDO – faster and higher-value purchasing without cumbersome tendering	Deliver GFR-compliant technical-superiority documentation to DST, ICMR, ICAR, DRDO, AIIMS purchase officers during June Delhi events; flag items under ₹2 lakh as direct-purchase eligible; prepare one-page technical comparison vs nearest GeM alternatives
BIS 214 Device Standards Programme and SUGAM Portal (NABL/CDSCO integration)	Fast-tracking standards for 214 critical devices; SUGAM automated for Market Standing and Non-Conviction Certificates	Tenders in Q2-Q3 2026 are requiring current BIS compliance certificates; superseded standards disqualify products from public procurement	Audit all product lines against current BIS/MHD standards; obtain conformance test reports from NABL-accredited labs for any product entering a government tender in the next 60 days; register for SUGAM portal access at sugam.gov.in if not yet done
Gujarat State R&D Assistance Scheme (SARDARDL; active 2026)	Financial assistance for Gujarat state-backed R&D institutions for equipment acquisition and lab infrastructure	Gujarat R&D labs supported under this scheme are in active procurement cycles for lab instruments	Identify Gujarat state-supported R&D institutions eligible under SARDARDL (list available at myscheme.gov.in); contact their purchase officers with targeted lab instrument offerings before competing suppliers move first

Disclaimer: Policy details are current as of 31 May 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) | DoP (www.pharmaceuticals.gov.in) | PHARMEXCIL (www.pharmexcil.com) | myScheme (www.myscheme.gov.in).