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Central Health Service Ministry Of Health And Family Welfare Real Time PCR Kit for SARS-CoV-2 Tender New Delhi 2026 MDR 2017 Compliant

Bid Publish Date

13-Jul-2026, 11:54 am

Bid End Date

23-Jul-2026, 12:00 pm

EMD

₹5,250

Location

NEW DELHI , DELHI
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Progress

Issue13-Jul-2026, 11:54 am
AwardPending
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Quantity

500

Bid Type

Two Packet Bid

Tender Overview

Central Health Service, under the Department of Health And Family Welfare, invites bids for a Real Time PCR Kit for SARS-CoV-2 / COVID-19 for delivery within Delhi. The scope encompasses the supply of in-vitro diagnostic kits with specified performance metrics, batch documentation, and regulatory compliance. The contract requires MDR 2017 compliance, valid drug license, and manufacturing unit certification, with attached test reports for each batch. The option clause allows up to 50% quantity variation, and the buyer emphasises integrity pact compliance and end-user certificate alignment. The EMD is ₹5,250, indicating a moderate-scale procurement, and the project targets timely supply to state health facilities in New Delhi. Emphasis on shelf life and minimum shelf life at delivery ensures product viability.

Technical Specifications & Requirements

  • Product: Real Time PCR Kit for SARS-CoV-2 / COVID-19
  • Detection: in-vitro; fluorescence-based with specified fluorescent probe
  • Targets: number of viral gene targets (as per BOQ/kit design)
  • Reaction: single/multi-step RT-PCR with compatible platform
  • Controls: included with each pack; document detailing methodology and interpretation
  • Shelf life: months from manufacture; minimum viability at delivery
  • Certifications: MDR 2017 compliance, valid drug license under Drugs and Cosmetic Act, manufacturing unit certification, batch test reports
  • Documentation: detailed product principle, performance data, dye used, storage, disposal, and supplier biosafety notes
  • Delivery scope: supply-only, with end-user certificate if requested by buyer
  • Installation/Support: not explicitly listed; ensure compatibility with common Real Time PCR systems
  • Reporting: batch-wise test reports to be provided at bid and delivery

Terms, Conditions & Eligibility

  • EMD: ₹5,250; payable to secure bid
  • Experience: evidence of supply to government/PSU or renowned private bodies along with PO
  • Registrations: Make in India authorization; MSME/NSIC exemptions if applicable; GST handling as per actuals
  • Integrity Pact: signed copy required; end-user certificate per buyer format
  • Option Clause: quantity may vary ±50%; delivery period adjusts proportionally
  • Turnover: three-year average turnover as per bid document; audited statements or CA certificate
  • Delivery & Payment: delivery schedule linked to PO; payment terms aligned with buyer policies
  • Submission: bid to include all licenses, test reports, and OEM authorizations as applicable

Key Specifications

  • Product: Real Time PCR Kit for SARS-CoV-2 / COVID-19

  • Detection: in-vitro; fluorescent probe-based detection

  • Gene targets: specified per kit (number to be clarified in BOQ/toolkit)

  • Reaction: RT-PCR compatible with standard real-time systems

  • Controls: per pack; documented interpretation and cycle information

  • Shelf life: months from manufacture; minimum shelf life at delivery

  • Certifications: MDR 2017 compliance; drug license under Drugs and Cosmetic Act; manufacturing unit certification

  • Documentation: detailed principle, methodology, validity criteria, dye, storage, biosafety statements

  • Batch testing: test reports for each batch as per MDR 2017

  • Delivery: supply-only; risk management with end-user document if required

Terms & Conditions

  • EMD ₹5,250; bid security to be furnished as per tender rules

  • Quantity may fluctuate up to 50% during ordering and currency of contract

  • Make in India authorization certificate required; MSME/NSIC exemptions if applicable

  • End User Certificate provided via buyer format on request; Integrity Pact mandatory

  • Delivery schedule tied to PO; GST handled as per actuals with applicable rates

Important Clauses

Payment Terms

Payment as per buyer policy; GST as actuals; EMD to be retained as bid security until satisfactory performance

Delivery Schedule

Delivery period linked to original PO; extended delivery time for option quantities calculated as (additional/original) × original period, minimum 30 days

Penalties/Liquidated Damages

Penalties for late delivery to be as per GeM/buyer terms; LD percentage not disclosed in data

Bidder Eligibility

  • Experience in supplying real-time PCR kits to government or PSUs

  • Valid MDR 2017 compliance and drug license

  • Manufacturing unit certification and OEM authorization

  • Three-year average turnover demonstrating financial capacity

Additional Tender Data

Commercial Details

Tender Category

Goods

Bid To RA

No

Bid To RA Enabled

Yes

Item Category

Real Time PCR Kit for SARS - CoV - 2 / COVID - 19 (Q2)

Advisory Bank

Bank Of Baroda

ePBG Percentage

1%

ePBG Duration (Months)

12

Delivery Details

Max Delivery Days

125

Delivery Locations

1

Delivery Cities

South

Delivery Pincodes

110029

Delivery Locations

ConsigneeAddressCityStatePincodeQuantityDelivery DaysAdditional Requirement
Puneet Arora110029,OFFICE OF THE MEDICAL SUPERINTENDENT SAFDARJUNG HOSPITAL NEW DELHI-110029SouthDelhi110029-125-

Authority Records

MINISTRY OF HEALTH AND FAMILY WELFAREHEALTH AND FAMILY WELFARE DEPARTMENT

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Documents 5

GeM-Bidding-9526969.pdf

Main Document

CATALOG-Specification-1

CATALOG Specification

Other Documents

OTHER

Other Documents

OTHER

GEM General Terms and Conditions Document

GEM_GENERAL_TERMS_AND_CONDITIONS

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Technical Specifications 1 Item

Item #1 Details

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Category Specification Requirement
GENERAL FEATURES Product Description Real Time PCR Kit For SARS-CoV-2/COVID-19
PRODUCT INFORMATION Type of Kit Real Time Reverse Transcription PCR Kit For SARS-CoV-2/COVID-19
PRODUCT INFORMATION Detection Type (in-vitro) Quantitative
PRODUCT INFORMATION Testing Principle One-step RT-PCR
PRODUCT INFORMATION Number of viral gene targets on which test is based At-least 2 or more genomic SARS-CoV-2 specific genes
PRODUCT INFORMATION Type of Reaction Multiplex Reaction
PRODUCT INFORMATION No cross reactivity Yes
PRODUCT INFORMATION Species Reactivity Human
PRODUCT INFORMATION Test compatible with Suitable for in-vitro qualitative detection of SARS-CoV-2 nucleic acids in throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and broncho alveolar lavage fluid (BALF) from individuals who are suspected of COVID-19
PRODUCT INFORMATION Result Time ≤ 90 minutes Or higher
PRODUCT INFORMATION Sensitivity ≥ 95% Or higher
PRODUCT INFORMATION Specificity ≥ 99% Or higher
PRODUCT INFORMATION Reagent included in the kit Primer, Probe, enzymes
PRODUCT INFORMATION Control provided with each pack of kit Internal control which validates sample quality, RNA extraction and RT-PCR reaction
PRODUCT INFORMATION Type of Fluorescent Probe used for the detection RT-PCR Kit for detecting SARS-CoV-2 uses fluorescent probe based TaqMan chemistry with multiplex reactions in a single tube. Probes have have reporter dyes in the range of spectral separation to have compatibility with common RT-PCR machines available. Probe for each gene should have separate dye/fluorophore so that the result for each gene can be read individually
PRODUCT INFORMATION Compatibility with Real Time PCR System Closed
PRODUCT INFORMATION Document detailing principle,component,methodology,validity criteria,result interpretation,cycle information,gene name,respective dye used,performance characteristic,biosafety,assay limitation,storage condition,mfg & exp date,disposal method provided Yes
CERTIFICATIONS & REPORTS Compliance to 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 Manufacturing unit certification ISO:13485 (Latest)
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 and along with supplies as per buyer requirement Yes
SHELF LIFE Shelf life from the date of manufacture (in months) 24 Or higher
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 certificate

2

PAN card

3

Experience certificates for government/PSU or reputed private buyers

4

Audited financial statements or CA certificate confirming three-year turnover

5

EMD submission document (₹5,250) via DD/online

6

MDR compliance certificate and drug license validity

7

Manufacturing unit certification

8

Test reports per MDR for each batch

9

OEM authorization and Make in India authorization

10

Signed Integrity Pact

11

End User Certificate (if requested by buyer)

Frequently Asked Questions

Key insights about DELHI tender market

How to bid for the real time PCR kit tender in New Delhi?

To bid, submit MDR 2017 compliance documents, valid drug license, and manufacturing certificate. Include EMD ₹5,250, Make in India authorization, OEM authorizations, and batch test reports. Ensure three-year turnover proof and signed Integrity Pact; delivery terms align with PO timelines and 50% quantity option.

What documents are required for the SARS-CoV-2 PCR kit procurement in Delhi?

Required documents include GST certificate, PAN card, audited financial statements or CA certificate for turnover, MDR compliance certificate, drug license, manufacturing unit certification, test reports per MDR, OEM authorization, Integrity Pact, and EMD receipt. End User Certificate may be requested in buyer format.

What are the technical specifications for the MDR compliant PCR kit in this tender?

Key specs include in-vitro detection with fluorescent probe, reference to batch test reports, shelf life in months from manufacture, compatibility with standard Real Time PCR systems, and documentation detailing principle, gene targets, dye used, and disposal. Cross-reactivity not allowed and exact gene targets per kit must be clarified in bid.

When is the delivery timeline and how are quantities adjusted in this contract?

Delivery scope is supply-only; quantity may vary up to 50% at award and during currency. Delivery period is adjusted proportionally using ((additional quantity / original quantity) × original delivery period), with a minimum of 30 days. Ensure readiness for scaled orders and stock management.

What are the eligibility criteria for Make in India authorization in this PCR kit bid?

Bidders must provide Make in India authorization certificate to participate. If MSME/NSIC exemption applies, include exemption certificate. Ensure MDR compliance, drug license, and manufacturing unit certification to meet buyer requirements for government procurement in Delhi.

What are the EMD and turnover requirements for this PCR kit tender in Delhi?

EMD paid as ₹5,250 to secure bid submission. Turnover must meet the three-year average threshold specified in the bid document, supported by audited balances or CA certificate. Solid financial standings help ensure eligibility for supply to government buyers.

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