Gujarat Panchayats & Rural Housing Department Sickle Cell Solubility Test Kit Tender 2025

Tender Overview

The procurement targets a Sickle Cell Solubility Test Kit (V2) for Gujarat’s Panchayats And Rural Housing Department, with an EMD of ₹60,000 and a stated need for MDR 2017 compliance, drug licensing, and batch test reports. The package requires kit components, literature in English, and adequate documentation to support storage, transport, and testing. A mandatory advance sample and on-site maintenance considerations accompany delivery obligations, while optional quantity adjustments up to 25% may be exercised during contract execution. This tender emphasizes quality certification, batch testing, and supplier capability to establish a state-wide service footprint if needed. The buyer’s ATC terms mandate ISO-13485, CE/GMP, FDA-related facility documentation, and GS1 certification as part of bidder uploads. Location-specific requirements, service centre readiness, and shelf life criteria shape supplier selection.

• Organization: Panchayats And Rural Housing Department, Gujarat
• Product category: General medical diagnostic kit (Sickle Cell Solubility)
• Estimated value/quantity: Not disclosed; EMD ₹60,000
• Location: Gujarat state; delivery-to-site considerations & temperature-controlled transport
• Unique aspects: MDR 2017 compliance, literature and batch test reports, service centre requirements, option to increase quantity by 25%

Technical Specifications & Requirements

• Product: Sickle Cell Solubility Test Kit (V2) with components: Solubility Buffer, Solubility Reagent Powder, required literature in English detailing components, test principle, validity, storage, expiry, and limitations
• Storage/Transport: Maintain recommended temperature during transport and at final destination; ensure kit remains within specified storage temperature
• Certification/Quality: Compliance to Medical Device Rules (MDR) 2017; valid drug license under Drugs and Cosmetics Act; Manufacturing unit certification; batch test reports per MDR 2017; provide certifications and licenses to buyer at bid/supply
• Shelf Life: Minimum shelf life required; specify months from manufacture and minimum deliverable shelf
• Advance Sample: Agreement to provide advance sample for buyer approval before supply
• Service/Support: Functional service centre in each consignee state; if not present, establish within 30 days of award; payment conditional on evidence of service centre
• Documentation: OEM authorizations, ISO-13485 copy, CE/GMP certificates, FDA-related facility registration, GS1 certificate

Terms, Conditions & Eligibility

• EMD: ₹60,000 (as per tender requirement)
• Delivery/Quantity: Option to increase/decrease quantity up to 25% of bid quantity; extended delivery period calculated on basis of increased quantity with minimum 30 days
• Service Centers: Required in each consignee state; establishment within 30 days of award; payment contingent on evidence
• Financial Standing: Bidder must not be in liquidation or bankruptcy; provide an undertaking
• Documentation: Upload all required certificates, product brochures, and ATC-compliant documents; ensure MDR-related test reports accompany bid
• ATC Clauses: ISO-13485 (notified body per CDSCO), CE/GMP, FDA facility certification, GS1
• Warranty/Support: On-site or carry-in warranty terms; service centre availability is critical for payment release