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GEM

Central Health Service MOHFW Blood Grouping Reagents Tender New Delhi 2026 CDSCO MDR 2017

Bid Publish Date

20-Feb-2026, 11:54 am

Bid End Date

02-Mar-2026, 12:00 pm

EMD

₹9,490

Location

NEW DELHI , DELHI

Progress

Issue20-Feb-2026, 11:54 am
AwardPending
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Quantity

100000

Category

Anti - A Blood Grouping Reagent

Bid Type

Two Packet Bid

Categories 1

REAGENT

Tender Overview

The Central Health Service under the Ministry of Health and Family Welfare invites bids in New Delhi for a range of blood grouping reagents, including Anti-A, Anti-B, Anti-AB, and Anti-D sera. The procurement emphasizes ready-to-use reagents with precise antigen specificity, observable agglutination, and non-hemolytic performance. Bidders must meet CDSCO/NIB appearance, color, sensitivity, and titer standards, and provide batch test reports under MDR 2017. A minimal EMD of ₹9,490 applies, and the scope is supply-only with advance sample approval. The award targets suppliers capable of sustained supply with compliant manufacturing units and documented QA.

Technical Specifications & Requirements

  • Reagents: Anti-A, Anti-B, Anti-AB, and Anti-D sera; ready-to-use with dropper; capable of detecting all weak/partial D.
  • Performance: easy observable agglutination on antigen-positive cells; no agglutination on antigen-negative cells; avidity < 4 seconds; non-hemolyzing and non-rouleaux forming.
  • Standards: CDSCO/NIB approvals; MOHFW blood bank manual compliance; MDR 2017 compliance; valid drug license under Drugs and Cosmetic Act 1940; batch test reports for MDR.
  • Packaging & labeling: pack size; packaging insert; shelf-life across months from manufacture; minimum shelf life at delivery.
  • Advance sample: pre-bid sample approval required; manufacturing unit certification and OEM authorizations may be requested.

Terms, Conditions & Eligibility

  • EMD: ₹9,490; payment terms documented in bidder terms; supply scope is goods-only.
  • Experience turnover: bidder and OEM must meet three-year turnover criteria as specified; audited balance sheets or CA certificates required.
  • Compliance: manufacturer must provide MDR-compliant certifications, drug license, and test reports with bid or on delivery; MSME/NSIC exemptions may apply with proper certificates.
  • Delivery: timetable and penalties, if any, to be defined in the final PO; advance sample approvals essential for bidding.
  • Documentation: GST, PAN, experience certificates, financials, OEM authorizations, and technical compliance files as per buyer requirement.
  • Misc: Make in India authorization, purchase preference for MSEs if applicable; adherence to buyer terms for samples and certificates.

Key Specifications

  • Anti-A blood grouping reagent: ready-to-use sera with A antigen specificity

  • Anti-B, Anti-AB, Anti-D reagents with dropper; capable of detecting weak/partial D

  • Avidity < 4 seconds; no hemolysis or rouleaux; clear positive/negative agglutination

  • CDSCO/NIB appearance, color, sensitivity, specificity, titer strength validated

  • MOHFW technical manual compliance for blood banks

  • Pack size and labeling as per packaging requirements; shelf-life months from manufacture

Terms & Conditions

  • EMD amount of ₹9,490; supply-of-goods scope; advance sample required

  • Three-year turnover criteria for bidder and OEM; audited docs required

  • MDR 2017 compliance, drug license, batch test reports mandatory at bid or delivery

Important Clauses

Payment Terms

Bidder to provide payment terms as per buyer terms; EMD submitted with bid; advance sample approval before supply

Delivery Schedule

Supply of reagents as per PO timeline; minimum shelf life to be maintained at delivery; penalties as per contract

Penalties/Liquidated Damages

Penalties for non-compliance with MDR, drug license validity, or batch test reports; LDs to be defined in final contract

Bidder Eligibility

  • Must provide three-year average annual turnover evidence

  • OEM turnover criteria met for primary product category

  • Make in India authorization certificate and MSME/NSIC exemption documents (if applicable)

Documents 7

GeM-Bidding-8930756.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

CATALOG-Specification-2

CATALOG Specification

CATALOG-Specification-3

CATALOG Specification

CATALOG-Specification-4

CATALOG Specification

Buyer uploaded ATC document

ATC

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Posted: 4 February 2026
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Technical Specifications 4 Items

Item #1 Details

View Catalog
Category Specification Requirement
GENERAL FEATURES Type of Blood Grouping Sera/Reagent Anti-A Blood Grouping Sera IgM
GENERAL FEATURES Antibody Type Monoclonal
GENERAL FEATURES Suitable for Tube Method, Slide Method
GENERAL FEATURES Ready to use reagent containing antibodies specific to the 'A' antigen on RBC Yes
GENERAL FEATURES Titre ≥ 1:256 with A cell and negative with B Cell
GENERAL FEATURES Dropper Provided Yes
GENERAL FEATURES Reagent should have avidity less than 4 seconds < 4 seconds
GENERAL FEATURES Should not hemolyze cells or produce rouleux Yes
GENERAL FEATURES Storage Temperature 2°C to 8°C
GENERAL FEATURES It should give easily observable agglutination reaction with antigen positive cells and clear absence of agglutination reaction in antigen negative cells Yes
GENERAL FEATURES Reagent should meet the standards approved by CDSCO/NIB for blood bank reagents with respect to appearance, color, sensitivity, specificity, avidity, affinity and titer strength Yes
GENERAL FEATURES Reagent should meet the standards mentioned in the technical manual for blood banks approved by the MOHFW, GOI Yes
PACKAGING AND LABELING Pack size 10 ml
CERTIFICATIONS & REPORTS Compliance with Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Availability of valid drug 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
CERTIFICATIONS & REPORTS Availability of Test Report for each supplied batch/product as per Medical Device Rules (MDR) 2017 as amended till date Yes
CERTIFICATIONS & REPORTS Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement Yes
SHELF LIFE Shelf life in months from the date of manufacture 24, 36 Or higher
SHELF LIFE Minimum shelf life of the product at the time of delivery to the consignee 3/4th of Total Shelf Life
ADVANCE SAMPLE Agree to provide advance sample of the product for buyer's approval before commencement of supply in case of bidding Yes

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Required Documents

1

GST certificate

2

PAN card

3

Experience certificates for Government/PSU supply

4

Audited financial statements or CA certificate for turnover (last 3 years)

5

OEM authorization and Make in India certificate

6

MDR compliance certificates and batch test reports

7

Drugs and Cosmetics Act drug license

8

Manufacturing unit certification

9

Submission of all certifications/licenses/test reports at bid submission or with supplies

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for blood grouping reagents tender in New Delhi 2026?

Bidders must submit GST, PAN, three-year turnover evidence (audited statements or CA certificate), OEM authorizations, and MDR-compliant batch test reports. Provide advance sample for buyer approval and ensure CDSCO/NIB compliance and MOHFW manual alignment. EMD is ₹9,490 and supply is goods-only.

What documents are required for MOHFW blood reagent procurement 2026?

Required documents include GST certificate, PAN, experience certificates for government/PSU supply, audited turnover statements, OEM authorization, MDR and drug license certificates, batch test reports, and manufacturing unit certification. Submit at bid or with supplies as per buyer requirement.

What standards must rival reagents meet for this tender?

Reagents must be CDSCO/NIB approved for appearance, color, sensitivity, specificity, avidity and titer strength; comply with MOHFW technical manual; MDR 2017 compliance; valid drug license under D&C Act; batch test reports for each supplied lot.

What is the required EMD amount for this blood grouping tender in Delhi?

The EMD is ₹9,490. It must be submitted as per tender terms, typically via online or demand draft. Ensure EMD accompanies the bid to qualify for evaluation and prevent bid rejection.

What is the minimum shelf life requirement for delivery?

Bidders must ensure minimum shelf life as stated: months from manufacture, with delivery meeting the minimum shelf life at consignee. This ensures product viability at the point of use in the blood bank.

What delivery and payment terms apply to MOHFW reagent supply?

The contract specifies goods-only scope; advance sample approval; payment terms align with buyer terms; penalties/LD may apply for delays or non-compliance; detailed terms will be finalized in the PO.

What experience criteria must OEMs meet for this procurement?

OEM turnover must meet three-year average annual turnover criteria; provide audited balance sheets or CA certificates indicating turnover. If OEM is under 3 years, use completed years post-incorporation to calculate turnover for eligibility.

Are Make in India authorizations required for participation?

Yes, Make in India authorization is required or strongly preferred; bidders must enclose Make in India certificate along with bid to qualify under eligibility criteria and possible MSE preferences.