Indian Air Force USFDA/DGCI Approved Everolimus Drug-Eluting Third Generation Platinum-Chromium Coronary Stent Tender 2026

Tender Overview

The Indian Air Force invites bids for a USFDA/DGCI approved Everolimus drug-eluting coronary stent (third generation) with platinum-chromium backbone. The tender references a Medicines/Medical device category and requires OEM/authorized distributor authorization, ISO 9001 certification, and material test certificates. Notably, shelf-life remains a critical factor, with a minimum two-to-three years shelf life and five-sixth shelf life remaining at supply. The terms emphasize GST invoicing in the GeM portal and adherence to option clauses allowing up to 50% quantity variation. A replacement undertaking for unutilised medicines within three months before expiry is specified. No BOQ items are listed, suggesting a focused, high-value medical device procurement from IA F.

Key differentiators include formal OEM authorization, mandatory ISO 9001, and rigorous lab testing by the buyer, with results determining acceptance. The procurement stance centers on regulatory compliance, traceability, and post-supply support, typical of critical medical devices in defense procurement. The absence of explicit quantities or delivery timelines points to a flexible, demand-driven mechanism governed by option and extension clauses.

Technical Specifications & Requirements

• Product: Everolimus drug-eluting stent (3rd generation) with platinum-chromium alloy construction
• Regulatory approvals: USFDA and DGCI clearance; OEM authorization from the manufacturer for distributors
• Certifications: ISO 9001 certification required for bidder or OEM; Material Test Certificate to accompany supply
• Shelf life: minimum 2–3 years at supply; at least five-sixth shelf life remaining on delivery
• Quality/Testing: buyer’s lab to conduct material tests; acceptance based on lab results
• Invoicing: GST invoice submission and GST portal payment screenshot in GeM
• Warranty/Aftercare: replacement undertaking for medicines unused up to three months before expiry; 3–5 year support or warranty not explicitly stated but implied by replacement clause

Terms, Conditions & Eligibility

• EMD/Financials: Not explicitly stated in the data; bidders must ensure GST registration and PAN as part of bid submission
• Documents: mandatory copies of PAN, GSTIN, canceled cheque, EFT mandate; OEM authorization if bid via distributor
• Delivery/Option Clause: purchaser may adjust quantity up to 50% at contract award and during the currency at contracted rates; delivery period adjustments follow a defined formula with minimum 30 days
• Shelf Life Commitments: medicines must meet the defined shelf-life criteria at delivery; replacement for unutilised stock within three months before expiry
• Certification/Compliance: non-submission of required certificates may lead to rejection; ISO 9001 is mandatory
• Payment Terms: not detailed beyond GST invoicing; GeM portal GST compliance needed
• ATC/Attachments: bidder must view uploaded ATC documents for additional terms