CDSCO Mandates e-RaktKosh Registration for Blood Centres in India: Guidelines, Compliance & Checklist

CDSCO Mandates e-RaktKosh Registration for Blood Centres in India: Guidelines, Compliance & Checklist

Introduction

India’s healthcare system is rapidly moving towards digital transparency, and blood bank management is no exception. In its latest update, the Central Drugs Standard Control Organisation (CDSCO) has emphasized the mandatory registration of licensed blood centres on the e-RaktKosh portal.

This move aims to strengthen the national blood management system and ensure effective e-RaktKosh registration in India, improving real-time blood availability and regulatory compliance.

What is e-RaktKosh Portal?

The e-RaktKosh portal is a centralized digital platform developed under the National Health Mission to manage:

1. Blood stock availability

2. Donor database

3. Blood bank inventory tracking

4. Real-time reporting system

It acts as a digital blood bank management system in India, enabling authorities to monitor blood availability efficiently.

CDSCO Advisory: What Has Changed?

According to the latest CDSCO blood centre guidelines, all licensed blood banks must:

1. Complete e-RaktKosh registration

2. Regularly update blood stock data

3. Maintain donor and inventory records online

This makes e-RaktKosh compliance mandatory for blood centres, strengthening transparency and accountability.

Why e-RaktKosh Registration is Mandatory

The government has made blood bank registration on e-RaktKosh portal compulsory due to:

1. Real-time blood inventory tracking in India

2. Improved emergency response system

3. Better donor database management

4. Stronger regulatory monitoring (CDSCO compliance)

This step supports the vision of a digitally integrated healthcare system in India.

How to Register on e-RaktKosh Portal (Step-by-Step)

If you’re running a licensed blood centre, here’s how to complete e-RaktKosh registration:

1. Visit the official e-RaktKosh portal

2. Click on blood bank registration

3. Enter licence and centre details

4. Upload required documents

5. Submit and wait for approval

Once approved, ensure regular data upload to stay compliant.

Accordingly, the following actions shall be ensured:

1. All CDSCO Zonal/Sub-Zonal Offices shall coordinate with the respective State Licensing Authorities to ensure that all licensed Blood Centres under their jurisdiction are registered on the e-RaktKosh Portal.

2. State Licensing Authorities (SLAs) shall direct all licensed Blood Centres to:

Complete registration on the e-RaktKosh Portal, wherever not done.

3. Ensure regular updating of blood stock and component availability on the portal.

4. It has further been decided that verification of e-RaktKosh registration and its active usage shall be included as part of the regulatory inspection process of Blood Centres.

5. Accordingly, Annexure-O (Inspection Checklist for Blood Centres) of the "Guidance Document for CDSCO Zonal and Sub-Zonal Offices shall also be updated to include verification of e-RaktKosh registration and compliance during inspections.

6. All SLAs are requested to furnish a status report within 30 days indicating:

1. Total number of licensed Blood Centres in the State/UT

2. Number of Blood Centres registered on e-RaktKosh

3. Number of Blood Centres yet to be registered

For uniform implementation, the following points may be verified during inspection of Blood Centres and it shall be incorporated in Annexure-O(Inspection Checklist for Blood Centres):

1. Whether the Blood Centre is registered on the e-RaktKosh portal.

II. Whether the unique e-RaktKosh ID has been generated for the Blood Centre.

III. Whether the license details (Form 28C/applicable license details) are correctly updated on the portal.

IV. Whether details of Blood Centre infrastructure, component facilities, and services are updated on e-RaktKosh.

V. Whether blood stock and component availability are being regularly updated on the portal.

VI. Whether the Blood Centre has designated staff responsible for data entry and portal management.

VII. Whether the contact details of the Blood Centre and nodal officer are updated on the portal.

VIII. Whether consistency exists between physical blood stock and stock reflected on the portal.

IX. Whether login credentials are functional and the portal is being regularly used.

X. Whether donor details are captured in the system for traceability purposes.

XI. Whether donor traceability is maintained through linkage with ABHA ID / Aadhaar or other approved unique identifiers, wherever applicable, in accordance with applicable Government guidelines.

Conclusion
The CDSCO’s mandate for e-RaktKosh registration is a significant step toward strengthening India’s digital healthcare ecosystem. By ensuring real-time blood tracking, transparency, and compliance, this initiative will improve patient safety and streamline blood bank operations across the country.

FAQs

1. Is e-RaktKosh registration mandatory for blood banks in India?

Yes, as per CDSCO advisory, all licensed blood centres must register on the e-RaktKosh portal.

2. What is the purpose of e-RaktKosh portal?

It is used for blood inventory tracking, donor management, and real-time data reporting.

3. How can a blood bank register on e-RaktKosh?

By visiting the portal, submitting licence details, and completing the registration process online.

4. What happens if a blood centre does not comply?

Non-compliance may result in regulatory action under CDSCO guidelines.

5. What are the benefits of e-RaktKosh for hospitals?

It improves blood availability tracking, emergency response, and transparency.

Access the official CDSCO guidance document on blood centre registration

Note:
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