Centre to legally mandate external quality audits of blood banks

Following a series of blood transfusion safety breaches, the Centre is making external quality audits and centralized digital inventory tracking mandatory for India’s 4,153 blood banks to strengthen patient safety, according to two officials and documents reviewed by Mint.

As part of the overhaul, the government is converting existing voluntary guidelines into legally binding requirements under the Drugs Rules by aligning India’s transfusion safety protocols with World Health Organization (WHO), European Union and US accreditation standards.

The move follows several cases in which children tested positive for HIV after blood transfusions in Satna (Madhya Pradesh), West Singhbhum (Jharkhand), Jaipur (Rajasthan) and Kamrup (Assam) due to breaches in screening protocols. Mint had earlier reported that the government was planning nationwide blood bank audits.

Queries sent to the health ministry and the DCGI office remained unanswered till press time.

Digital tracking
The Centre will also make registration of all blood banks on e-RaktKosh—the central digital platform managed by the Ministry of Health and Family Welfare and C-DAC—mandatory to enable real-time monitoring of blood stocks and curb inventory hoarding.

The reforms aim to modernize India’s blood transfusion infrastructure, dismantle the culture of replacement donations and the “professional donor” racket, and move towards a fully voluntary, non-remunerated blood donation system. The changes assume significance given India’s annual blood requirement of 14.6 million units.

“The regulatory framework is now advancing to turn these targeted inspections and centralized inventory tracking into standard, legally binding provisions under the law,” an official aware of the matter said, requesting anonymity.

“The audit has been initiated now. The States and Union Territories are conducting these at their own level. However, this was not previously mandatory. Once it is incorporated under the Drugs Rules, it will become a legal requirement,” the official added.

Global standards
“Participation in External Quality Assessment Schemes (EQAS) ensures continuous quality monitoring and standardization across blood centres. At present, EQAS participation is recommended but lacks explicit enforceability under statutory provisions,” the document stated.

“In view of evolving global best practices and patient safety requirements, there is a need to incorporate specific provisions in the Drugs Rules,” it added.

Experts said the reforms would improve blood inventory management, strengthen emergency preparedness and reduce risks associated with manual errors.

Expert view
Dr Ravneet Kaur, senior DGM and lab head at Agilus Diagnostics Lab, Fortis Noida, said:

“Under the current regulatory framework, EQA participation and centralized digital tracking are treated largely as voluntary practices, but this shift embeds them directly into the Drugs Rules as mandatory licensing conditions. Introducing compulsory EQA transforms quality monitoring from a one-time licensing event into a continuous grading mechanism. Blood centers will regularly test blind samples for blood grouping, cross-matching, and transfusion-transmitted infections (TTIs) like HIV, HBV, and HCV.”

“These regular external audits make facilities accountable for their internal systems, while aligning Indian transfusion safety protocols with World Health Organization (WHO), European Union and United States accreditation standards.”

She said compulsory registration of all blood banks on e-RaktKosh would enable authorities to monitor real-time blood availability. Currently, blood transfusion centres are required to register on the Central Drugs Standard Control Organisation’s (CDSCO) Online National Drug Licensing System primarily for regulatory record-keeping.

“Enforcing 100% e-RaktKosh registration through State Licensing Authorities makes licence renewals contingent on compliance to address gaps in supply chains and inventory hoarding. This approach targets two main vulnerabilities in transfusion medicine: laboratory testing errors and component scarcity during emergencies by mandating statutory compliance to ensure traceability, quality assurance, and transparency for patients,” Kaur added.

India’s annual blood requirement is estimated at 14.6 million units, with an estimated shortfall of around one million units.

Dr Smriti Uppal, senior consultant – Obstetrics & Gynaecology, Pacific One Health, said:

“We encounter bleeding during childbirth, high-risk pregnancies, miscarriages, and gynaecological surgeries, where the availability of safe blood is required. While availability of blood is necessary, its screening and traceability are also required. Making EQA mandatory will establish uniform testing standards across blood banks, lowering the risk of transfusion-related complications and giving clinicians clarity in emergency situations. At the same time, e-RaktKosh can improve the tracking and accessibility of blood during shortages.” Livemint