Policy Summaries

• Draft Medical Devices Rules Amendment 2026 – G.S.R. 270(E) (notified 10 April 2026): Proposes amendments to Medical Device Rules 2017 including formalising a Certificate of Registration, clarifying fee schedules for testing, and refining definitions and procedural wording to improve regulatory clarity. Affects registration workflows and cost structures for manufacturers and importers of medical devices and diagnostics.
• Parliamentary Committee Report – Promotion of Medical Device Industry (tabled early 2026): The Standing Committee on Chemicals and Fertilizers recommended reduced GST on domestic devices, customs-duty concessions on key inputs, and expanded Phased Manufacturing Programmes. Also emphasised scaling domestic R&D and aligning regulatory capacity with sector growth targets.
• Tax and Duty Recommendations for Medical Devices (Parliamentary Committee, 2024-26): Recommends reduced GST rates on domestically produced devices and customs-duty concessions on imported inputs including electronic components, plastics and reagents to support competitiveness until the domestic supply chain matures.
• Gujarat State R&D Assistance Scheme (SARDARDL, active 2026): Gujarat government scheme providing financial assistance to state-backed R&D institutions for equipment acquisition and lab infrastructure; eligible institutions are in active procurement cycles.
• National Conference on Strategic Trade Controls (NCSTC) 2026 – New Delhi (15 January 2026): India’s flagship SCOMET and strategic trade controls platform; 2026 edition covered quantum tech, advanced computing, semiconductors, additive manufacturing and cybersecurity alongside the Third Edition Handbook on India’s Strategic Trade Control System. Directly influences export procedures for high-end instrumentation.
• Clin Lab India Conference 2026 – “Policies that Power Diagnostics” (30 January 2026): High-level panel on PLI 2.0 for IVD and MedTech, CDSCO modernisation, manufacturing clusters and diagnostic supply chain policy. Provides direct policy insight for diagnostic manufacturers and supply-chain partners.
• 9th Annual Pharma Regulatory Summit 2026 (24 March 2026, Mumbai): Themed “Driving Regulatory Excellence for a Changing Pharma Landscape”; addressed drug-regulation changes, GMP, data integrity and pharmacovigilance – shapes demand for compliant lab and production equipment with data-integrity enabled instruments.
• 9th India Pharma 2026 Conference (13-14 April 2026, New Delhi): Organised by Department of Pharmaceuticals, FICCI and IPA; highlighted continuous manufacturing, PAT (process analytical technology) and automation as key directions – indicates growing demand for advanced process control and PAT-linked instruments.
• Pharmexcil Chintan Shivir & SSMDI Workshops (April and February 2026): Chintan Shivir focused on scaling pharma exports; SSMDI workshops at NIPER Hyderabad covered testing infrastructure, common facilities and skill development in device clusters – indicates future expansion of testing labs where SIDMA members can supply lab and QA equipment.
• 10th Annual Medical Device Regulatory & Quality Summit 2026 – New Delhi (dates TBD): Reviews CDSCO rules, BIS standards, quality systems, clinical evaluation, MDR changes, EU sustainability trends and marketing-code initiatives. Key venue to understand regulatory expectations driving demand for validation, testing and calibration equipment.
• Customs & Trade Compliance India Summit 2026 (11th Edition): Inventicon Business Intelligence event on customs, import/export compliance, STPI/SEZ rules, tariff changes and documentation best practices. Relevant for SIDMA importers managing HS classification and valuation issues.
• DIA-KMTC MedTech Conference 2026 – Kerala: DIA with Kerala Medical Technology Consortium; covers regulatory, clinical and quality aspects for medical devices. Particularly relevant for members working with Kerala-based hospitals and manufacturers.

Actionable Policy Table

Policy / Reform	What It Does	Why It Matters in the Next 60 Days	Key Action for SIDMA Members
Delhi Government Centralised Hospital Procurement	All Delhi government hospital equipment purchases routed through a central procurement agency	Existing hospital-level relationships in Delhi are no longer the primary procurement channel for government hospitals	Identify and register with Delhi’s central procurement agency immediately; restructure Delhi government hospital sales strategy from individual hospitals to agency-level engagement
BIS December 2025 Standards – Transition deadline passed 15 June 2026	Old BIS standard versions are now invalid; only revised versions apply to procurement and tenders	Any product still referencing superseded BIS standards is disqualified from public procurement effective immediately	Verify all product lines immediately against current BIS standards; update labelling, conformance documentation and NABL test reports; do not respond to any tender with superseded standard references
GFR-based Procurement – Research Institutions	Raises limits and removes GeM-only constraint for scientific equipment at R&D bodies	Active procurement cycles at CSIR, ICMR, IITs, DBT and DRDO	Deliver GFR-compliant catalogues and technical-comparison documents to purchase officers at upcoming July-August events and site visits
9th India Pharma Conference – PAT and Continuous Manufacturing	Government and industry aligned on Process Analytical Technology and continuous manufacturing as priority	Pharma plants planning PAT upgrades will issue RFPs for sensors, inline analysers and automation systems	Position PAT-capable instruments (inline NIR, FTIR, particle size analysers) with pharma OEMs exploring continuous manufacturing
Pharmexcil Chintan Shivir – Pharma Export Scale-up	Focus on scaling pharma exports; identifies product categories for export-orientation	Export-oriented pharma plants expanding capacity will need validated lab and QC instruments for export compliance	Target Pharmexcil-member companies for lab and QC equipment offerings; align proposals with export-compliance documentation requirements

Disclaimer: Policy details are current as of 21 June 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).