GEM Government Tender Linezolid Injection 200mg/100ml IV Chandigarh - GMP Schedule M ISO Requirements 2025

Tender Overview

The opportunity refers to procurement of Linezolid 200mg/100ml intravenous bottles for a government health program, located in Chandigarh. Bidder responsibilities include supplying units under GMP/WHO GMP regimes and ensuring compliance with Schedule M. The tender emphasizes adherence to hospital-rate pricing and batch-wise test reports stamped with GMCH-32, Chandigarh. A principal manufacturer authorization and integrity commitments may be required. No BOQ items are listed, indicating a turnaround focused on supplier capability and compliance rather than quantity-based scoping. Key differentiators include mandatory GMP/ISO alignment, batch testing, and supplier integrity provisions. Unique aspects include explicit stamping and hospital-rate pricing assurances, plus potential affidavit submissions.

Technical Specifications & Requirements

• Product name: Linezolid 200mg/100ml, IV bottle (batch-wide supply contemplated)
• Standards/Compliance: GMP under Drug & Cosmetic Act Schedule M or revised Schedule M; WHO GMP; if not ISO-certified by the principal, QMS/ISO may be required; if license issued under Medical Devices 2017, ISO/GMP may be exempt
• Documentation: Valid manufacturing license from principal manufacturer; principal manufacturer authorization letter if supplied by distributor; GMP/ISO/QMS certificates as applicable
• Quality & Lab: Batch test reports from approved Drug Controller laboratory for each supply; stamping “GMCH -32, Chandigarh supply not for sale” on packaging
• Bidding Conditions: Hospital-rate pricing confirmation; potential Integrity Pact; affidavit as per annexure from principal manufacturer
• ATC/ATC documents: Referenced file available; no explicit technical datasheet provided in BOQ

Terms, Conditions & Eligibility

• EMD/Financials: Not expressly stated; bidders should prepare standard bid security per government norms
• Experience: Prior authorization requirements from principal manufacturer; familiarity with hospital-supply contracts recommended
• Delivery & Warranty: Delivery timelines and warranty terms are not detailed; expect adherence to batch testing and stamp requirements
• Documents: GST registration, PAN, experience certificates, bank statements or financials, manufacturer licenses, GMP/ISO/QMS certificates, principal manufacturer authorization, and integrity pact if requested
• Penalties: Possible penalties or LD provisions not explicitly described; integrity pact indicates future compliance expectations
• Audit & Compliance: Compliance with Drug Controller lab testing and batch-wise verification is implied