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Central Government Health Scheme Blood Lancets and Anti-AB Blood Grouping Reagent Tender India 2026

Bid Publish Date

17-Feb-2026, 9:09 am

Bid End Date

02-Mar-2026, 10:00 am

Latest Corrigendum Available

Progress

Issue17-Feb-2026, 9:09 am
Corrigendum27-Feb-2026
AwardPending
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Quantity

1003

Category

Anti - AB Blood Grouping Reagent (V2)

Bid Type

Single Packet Bid

Key Highlights

  • MDR 2017 compliance and CDSCO/NIB approvals mandatory
  • Drugs and Cosmetic Act 1940 licenses required for product
  • Advance sample provision option before supply commencement
  • Manufacturing unit certification and MDR test reports required
  • Packaging insert and specified pack size must be included
  • MSME/NSIC EMD exemption clause may apply with certificate

Categories 3

Tender Overview

The Central Government Health Scheme (CGHS) invites bids for general blood bank reagents, specifically Blood Lancets and Anti-AB Blood Grouping Reagent (Q2) categories. The tender emphasizes MDR 2017 compliance, CDSCO/NIB approvals, and valid drug licenses under the Drugs and Cosmetics Act. Bid submissions require furnishing test reports, manufacturing certifications, and license validity, with an advance sample option for buyer approval prior to supply. The procurement integrates packaging, labeling, and shelf-life obligations, ensuring reagents demonstrate high sensitivity, specificity, and clear agglutination reactions for true antigen presence or absence. A MSME/NSIC EMD exemption clause is referenced in related terms, indicating potential vendor eligibility benefits. The scope prioritizes CDSCO-compliant blood grouping reagents that do not hemolyze cells and provide observable agglutination results under standard storage conditions. This is a specialized healthcare procurement opportunity within the Indian government framework, focusing on quality control and traceability in blood banks. The unique sourcing criteria include packaging inserts, kit-level certifications, and supplier responsibility for advance sampling if requested.

Technical Specifications & Requirements

  • Product information: Lancet cap, plastic handle, needle gauge details to be supplied; ready-to-use reagents with antibodies for A and B antigens on RBCs; dropper provided; reagents must not cause rouleaux.
  • Standards & licenses: MDR 2017 compliance; valid Drugs and Cosmetic Act 1940 license; ** CDSCO/NIB approvals** for blood bank reagents; manufacturing unit certification; MDR test reports.
  • Performance & quality: clear agglutination for antigen-positive cells; absence of agglutination for antigen-negative cells; shelf-life data and storage temperature specifications; packing type and pack size; packaging insert included; advance sample option available.
  • Documentation: submission of all certifications, licenses, and test reports with bid; adherence to labeling and appearance standards.

Terms, Conditions & Eligibility

  • EMD details: Not explicitly stated; MSME/NSIC exemption may apply if registered, with certificate enclosed.
  • Delivery & supply: Minimum shelf life must be stated at delivery; ready-to-use reagents must meet specified quality standards.
  • Documentation: GST registration, PAN, experience certificates, financial statements, EMD/SD, OEM authorizations, and technical bid documents as applicable to the buyer’s requirements.
  • Advance samples: Optional agreement to provide advance sample for buyer approval prior to commencement of supply.
  • Penalties/conditions: Compliance with MDR and Drug Act licenses; mandatory test reports; packaging/insertion requirements.

Key Specifications

  • General features: Blood Lancets and Anti-AB Blood Grouping Reagent (A/B antibodies) with ready-to-use formulation

  • Material: unspecified; Lancet cap, plastic handle details to be supplied

  • Needle size (Gauge): to be specified by bidder

  • Certification: MDR 2017 compliance, CDSCO/NIB approval, Drugs and Cosmetic Act 1940 license

  • Shelf life: minimum shelf life and shelf-life from manufacture to be provided

  • Storage: defined storage temperature range

  • Packaging: packing type, pack size, and packaging insert

Terms & Conditions

  • MDR 2017 compliance and CDSCO/NIB approvals required

  • Licenses under Drugs and Cosmetic Act 1940 mandatory

  • Advance samples may be requested before supply

Important Clauses

Payment Terms

Not specified; implied to follow government procurement norms with possible advance payments or milestones

Delivery Schedule

Delivery timelines not explicitly stated; bidders should prepare for supplier readiness per buyer requirements

Penalties/Liquidated Damages

Not detailed; standard government tenders apply LD provisions if delivery/default occurs

Bidder Eligibility

  • Vendor must demonstrate MDR 2017 compliance and CDSCO/NIB approvals

  • Valid Drugs and Cosmetics Act licensing must be shown

  • MSME/NSIC exemption may apply with certificate

Documents 4

GeM-Bidding-8996563.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 2 Items

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Product Description Blood Lancets
PRODUCT INFORMATION Material Medical grade Stainless Steel and Polymer
PRODUCT INFORMATION Lancet Cap Twist Off
PRODUCT INFORMATION Plastic handle Yes
PRODUCT INFORMATION Needle Size (Gauge) 22 G, 25 G, 28 G, 30 G, 31 G, 33 G
CERTIFICATION & REPORTS Compliance to Medical Device Rule (MDR) 2017 as amended till date Yes
CERTIFICATION & REPORTS Availability of valid medical device license for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date Yes
SHELF LIFE Minimum shelf life of the product at the time of delivery to the consignee 3/4 th of Total Shelf Life

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Required Documents

1

GST registration certificate

2

PAN card

3

Experience certificates for similar blood bank reagents

4

Financial statements (last 3 years)

5

EMD/Security deposit documentation (if applicable; MSME/NSIC exemption noted)

Corrigendum Updates

1 Update
#1

Update

27-Feb-2026

Extended Deadline

02-Mar-2026, 10:00 am

Opening Date

02-Mar-2026, 10:30 am

Frequently Asked Questions

Key insights about GUJARAT tender market

How to bid for CGHS blood bank reagents tender India 2026 with MDR compliance

Bidders must meet MDR 2017 compliance, possess CDSCO/NIB approvals, and hold valid Drugs and Cosmetics Act 1940 licenses. Prepare advance samples if requested, and submit test reports, certifications, and OEM authorizations. Ensure packaging inserts are included and EMD status per MSME/NSIC eligibility.

What documents are required for CGHS anti-AB reagent tender submission

Submit GST registration, PAN, 3-year financial statements, experience certificates for similar products, MDR test reports, manufacturing unit certification, drug licenses, and OEM authorizations. Include packaging inserts and any MSME/NSIC exemption certificates if applicable.

What are the technical specifications for MDR compliant blood grouping reagents

Reagents must be ready-to-use with A and B antibodies, provide observable agglutination for antigen-positive cells, no agglutination for negative cells, non-hemolyzing, compatible with CDSCO/NIB standards, and stored within specified temperature ranges with clear labeling and packing inserts.

When is the advance sample requirement for CGHS procurement

Advance sample submission is requested at bid submission stage if the buyer requires prior approval. Ensure timely provision of samples to the CGHS evaluation team to facilitate demonstration of agglutination clarity and kit performance against standards.

What are the licensing requirements for blood grouping reagents under Drugs and Cosmetic Act 1940

Bidder must hold a valid drug license under the Drugs and Cosmetic Act 1940, with current validity and compliance evidence. Include license number, issuing authority, and expiry date with bid documents for verification by CGHS.

What are the packaging and labeling requirements for CGHS blood reagents

Packaging must include packing type, pack size, and a packaging insert. Reagents should meet appearance, color, sensitivity, specificity, avidity, and titer strength criteria per CDSCO/NIB approvals, with clear labeling for storage conditions and usage guidance.

What certifications are mandatory for CGHS blood lancets and reagents

Mandatory certifications include MDR 2017 compliance, CDSCO/NIB approvals, Drugs and Cosmetics Act 1940 license, and manufacturing unit certification. Suppliers must provide test reports as per MDR and ensure certification submission with bid and supply deliveries.

How to ensure eligibility for MSME/NSIC EMD exemption in this tender

MSME/NSIC registered suppliers may claim EMD exemption by enclosing the respective exemption certificate. Verify validity and attach the certificate with bid documents to leverage potential exemption while meeting MDR and licensing requirements.