Centre flags serious lapses in state’s blood banks

Jaipur: Union health ministry has flagged “serious lapses” in Rajasthan’s blood bank management after inspections found shortcomings including inadequate record-keeping, lack of proper ELISA testing, and failures to communicate HIV-positive cases to the State AIDS Control Society.

In a Jan 15 letter, Union health secretary Punya Salila Srivastava wrote to Rajasthan principal secretary (health) Gayatri Rathore, asking the state to discourage continued reliance on replacement blood donation and instead promote voluntary, non-remunerated regular blood donors with support from the State Blood Transfusion Council.

Srivastava said blood transfusion services are the cornerstone of patient care and public health systems, and called for sustained attention to regulatory compliance, quality standards and robust operational practices to ensure safe, quality-assured blood and blood components.

A health department official said, “The Union health secretary underscored that all blood centres in the state must function strictly in accordance with applicable statutory provisions and national guidelines and standards issued from time to time by the National Blood Transfusion Council (NBTC).”

The ministry cited the necessity of ensuring compliance with the National Standards for Blood Centres and Blood Transfusion Services (2022), the Transfusion Medicine Technical Manual (2023), External Quality Assessment Scheme (EQAS) Operational Guidelines (2024), Guideline for Voluntary Blood Donation (2024) and the revised Donor Selection and Referral Guidelines (2025).

The letter also noted that Risk-Based Inspections (RBI) of Blood Centres were initiated by the Central Drugs Standard Control Organization (CDSCO), and State/UT authorities were asked to accord priority to the matter. It sought a comprehensive audit of blood centres in each State/UT under the stewardship of the State Drug Regulator, with checkpoints outlined.

The ministry reiterated that blood centres must operate with a valid licence and comply with regulatory standards on infrastructure, staffing, equipment and processes under the Drugs and Cosmetics Act, 1940, and its rules. It also reiterated mandatory testing of all blood units for transfusion-transmitted infections—HIV, Hepatitis B, Hepatitis C, Malaria and Syphilis—and called for strengthening HIV, Hepatitis B and Hepatitis C testing through fourth-generation CLIA/ELISA. Reactive units were to be discarded under the Bio-Medical Waste Management Rules, 2016.

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