The Maharashtra Food and Drug Administration (FDA) has issued its first comprehensive order aimed at ensuring the safety of blood banks across the state. FDA Commissioner Tukaram Mundhe announced the initiative on Friday, emphasising the necessity of protecting both patients and blood donors. This order marks a significant step towards regulating blood banks under existing legislative frameworks.

Mundhe clarified that human blood and its components are classified as “drugs” according to the Drugs and Cosmetics Act of 1940. As a result, blood centres and institutions are prohibited from collecting, processing, storing, or distributing blood without a valid licence. Compliance with the statutory requirements outlined in the Drugs and Cosmetics Rules of 1945 is mandatory for all blood centres.

Guidelines for Operational Standards and Quality Control

The order establishes detailed guidelines concerning the infrastructure needed for blood centres, as well as the qualifications required for personnel. It specifies policies for donor selection, blood collection, testing, component preparation, and storage. Additionally, the order covers the labelling of blood products, record management, quality control, biomedical waste management, the organisation of blood donation camps, safe transportation of blood, and the daily updating of information on the e-RaktKosh portal.

Mundhe noted that inspections of various blood centres had uncovered lapses in following these statutory requirements. The issuance of this order aims to facilitate effective and uniform implementation of provisions across the state. Blood banks must ensure the availability of specific infrastructure, including counselling rooms and quality control facilities, to enhance their operational capabilities.

Under the new regulations, it is essential for blood banks to employ qualified personnel such as medical officers, technical supervisors, blood bank technicians, nurses, and counsellors in accordance with prescribed norms. Additionally, all blood banks are mandated to adhere to the revised donor selection criteria established in 2020 and are required to conduct mandatory testing of blood for various infections, including HIV, Hepatitis B, Hepatitis C, Syphilis, and Malaria.

Mandatory Review and Compliance Procedures Initiated

The order stipulates that blood banks must ensure proper storage of blood and its components at designated temperatures. They are also required to provide separate quarantine facilities for blood units that are suspected of being contaminated. Adherence to procedures for labelling blood bags and maintaining records for a specified duration is critical, as is the preparation of blood components according to standard operating procedures.

Moreover, blood banks are instructed to undertake regular self-audits to monitor compliance with these new requirements. The FDA has mandated that all blood centres in Maharashtra review their existing practices immediately and implement necessary corrective actions in sync with this comprehensive order. This initiative seeks to standardise operations across the state’s blood banking system.

The direct aim of this comprehensive order is to enhance the overall safety and reliability of blood banks, thereby ensuring the health and wellbeing of both donors and recipients of blood products. By establishing a robust regulatory framework, the FDA aims to ensure a high standard of care and compliance across all blood-related services in Maharashtra.

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