**Executive Summary**
This document is a response to Lok Sabha Unstarred Question No. 1133 regarding audits on blood banks and promotion of blood donation in India, to be answered on December 5th, 2025. It details the regulatory framework, quality assurance measures, and initiatives undertaken by the government to ensure the safety and quality of blood transfusion services and to encourage voluntary blood donation. The response outlines various initiatives aimed at engaging different stakeholders and raising awareness on the need for safe blood donation and transfusion.
**Key Points / Main Content**
* **Regulatory Framework and Audits**
* The Central Drugs Standard Control Organisation (CDSCO) and State Drugs Licensing Authorities enforce regulations under the Drugs & Cosmetics Act to ensure the safety and quality of blood collection, storage, and processing.
* The Drugs and Cosmetics (Second Amendment) Rules, 2020, have further strengthened these regulations.
* **Quality Assurance**
* The publication of the National Standard for Blood Centres and Blood Transfusion Services (2nd edition, 2022) and the Transfusion Medicine Technical Manual (2023) provides standardized guidance for best practices.
* Operational guidelines for external quality assessment (issued in 2025) promote continuous quality improvement.
* The External Quality Assessment Scheme (EQAS) has been initiated for Dte. GHS supported blood centers in collaboration with Christian Medical College (KMC) Vellore, Santokba Durlabhji Memorial Hospital (SDMH), Jaipur & Indian Red Cross Society (IRCS), Mumbai.
* **Promotion of Blood Donation**
* Engagement with Government Departments, Public sector undertakings, States and Union Territories, international partners like WHO, voluntary organizations, blood donor associations, professional associations, and other stakeholders.
* Support for activities like blood donation camps, observance of events on Voluntary Blood Donation days, and motivating youth groups in coordination with agencies like Nehru Yuva Kendra Sangathan, National Service Scheme, Red Ribbon Clubs in various Universities and Colleges.
* A dedicated Radio Jingle and AV film campaign on voluntary blood donation is currently live (from 2nd to 31st December) on All India Radio and through Doordarshan (DD).
* The e-RaktKosh web portal serves as the interface for Blood Centers and registration of Blood donation camps and voluntary blood donors.
* A provision of four special casual leaves for Central Government employees for donating blood.
**Impact Analysis**
**Blood Banks and Transfusion Services**
* **Impact:** Enhanced quality and safety standards through regulatory compliance, standardized guidelines, and external quality assessment.
* **Action Required:** Adhere to the Drugs & Cosmetics Act regulations, implement the National Standard for Blood Centres and Blood Transfusion Services, participate in the External Quality Assessment Scheme, and utilize the e-RaktKosh portal.
**Government Departments and Public Sector Undertakings**
* **Impact:** Collaboration and engagement in promoting blood donation.
* **Action Required:** Participate in blood donation campaigns, create opportunities for employees to donate blood, and promote awareness on the need for safe blood donation.
**Central Government Employees**
* **Impact:** Opportunity to donate blood with provision for special casual leaves.
* **Action Required:** Consider donating blood and avail the provision of four special casual leaves.
**General Public/Youth**
* **Impact:** Increased awareness and motivation for voluntary blood donation.
* **Action Required:** Consider becoming voluntary blood donors and participate in blood donation camps.
Key Entities Referenced
Ministry of Health and Family Welfare: Primary government body responsible for audits and blood donation initiatives mentioned in the policy.
Drugs & Cosmetics Act: Law under which regulations for blood collection, storage, and processing are enforced.
External Quality Assessment Scheme (EQAS): Initiative for quality assessment of blood centres.
Central Drugs Standard Control Organisation: National level authority enforcing regulations under the Drugs & Cosmetics Act.
e-RaktKosh: Web portal serving as the interface for Blood Centres and registration of blood donation camps.
GOVERNMENT OFINDIA
MINISTRYOFHEALTHAND FAMILYWELFARE
DEPARTMENT OFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 1133
TO BE ANSWERED ON5THDECEMBER, 2025
AUDITONBLOOD BANKS
1133.SHRIRAO RAJENDRASINGH:
Will the Ministerof HEALTH AND FAMILYWELFARE be pleased to state:
(a) whether the Government has conducted any audit on blood banks operating with various
hospitals to ensure the quality of blood in the transfusion process in the country;
(b) if so, details of such audits conducted during the last five years, year-wise; and
(c) whether the Government has taken steps to promote blood donation among all sections of
the populace in the country, if so, the details thereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a) and (b): Central Drugs Standard Control Organisation at the national level and the State
Drugs Licensing Authorities at the state level enforce regulations under the Drugs & Cosmetics
Act, ensuring the safety and qualityof bloodcollection, storage, andprocessing. The Drugs and
Cosmetics (SecondAmendment) Rules, 2020, have further strengthened these regulations.
The publication of the National Standard for Blood Centres and Blood Transfusion
Services (2nd edition, 2022) and the Transfusion Medicine Technical Manual (2023) provides
standardized guidance for best practices. Operational guidelines for the external quality
assessment (issued in2025) promote continuousquality improvement.
The External Quality Assessment Scheme (EQAS) has been initiated in the country for Dte.
GHS supported blood centres in collaboration with Christian Medical College (KMC) Vellore,
Santokba Durlabhji Memorial Hospital (SDMH), Jaipur & Indian Red Cross Society (IRCS),
Mumbai, ensuring adherencetohigh standards inbloodtransfusion practices.
(c) Steps have been taken to engage with different Government Departments, Public sector
undertakings, States and Union Territories, international partners like WHO, voluntary
organizations like the Indian Red Cross Society, blood donor associations, professional
associations, and other stakeholders for creating opportunities to donate and raise public
awareness on the need for safe blood donation and transfusion in the country. The Governmentsupports various activities like conducting blood donation camps, observance of events on
Voluntary Blood Donation days, andmotivating youth groups in coordination with agencieslike
Nehru Yuva Kendra Sangathan, National Service Scheme, Red Ribbon Clubs in various
Universities andColleges, etc.
Further to mention that a dedicated Radio Jingle and AV film campaign on voluntary blood
donation is currently live (from 2nd to 31st December) on All India Radio and through
Doordarshan (DD) PAN India levelrespectively, to motivate the population, especially youth,to
be voluntaryblooddonors.
The e-RaktKosh web portal is earmarkedto serve as the interface for Blood Centres andalso for
registration of Blood donation camps and voluntary blood donors. The Government has also
made a provision of four special casual leaves for the Central Government employees for
donatingblood.
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