Maharashtra FDA issues first statewide blood bank safety order

The Maharashtra FDA has issued its first comprehensive order for blood banks across the state. The move seeks uniform compliance on donor screening, testing, storage and patient safety.

In Short

• Order prescribes infrastructure, staffing, testing, storage, recordkeeping standards
• Mandatory testing now covers HIV, hepatitis B, hepatitis C, syphilis and malaria
• Blood units need quarantine storage, proper labelling and prescribed temperature controls

The Maharashtra Food and Drug Administration has, for the first time, issued a comprehensive order for blood banks across the state to ensure the protection of patients and blood donors, FDA Commissioner Tukaram Mundhe said on Friday.

Mundhe said human blood and its components are notified as a "drug" under the Drugs and Cosmetics Act, 1940. Accordingly, no blood centre or institution is allowed to collect, process, store or distribute blood without a valid licence, and every blood centre must comply with the statutory requirements laid down under the Drugs and Cosmetics Rules, 1945.

The order lays down guidelines on the infrastructure required for blood centres, qualifications of personnel, donor selection, blood collection, testing of blood and blood components, component preparation, storage, labelling, record management, quality control, biomedical waste management, organisation of blood donation camps, safe transportation of blood, daily updating of information on the e-RaktKosh portal, and compliance with other regulatory requirements.

Mundhe said inspections of some blood centres showed that statutory requirements were not being fully followed. He said the order was issued to ensure effective and uniform implementation of these provisions across the state.

Under the order, blood banks must ensure the availability of infrastructure such as counselling rooms, quality control facilities and blood component processing facilities.

The order also says blood banks should have qualified medical officers, technical supervisors, blood bank technicians, nurses and counsellors as per prescribed norms.

Every blood bank must implement the revised 2020 donor selection criteria and carry out mandatory testing of every unit of blood for HIV, Hepatitis B, Hepatitis C, Syphilis and Malaria.

Blood banks must also ensure proper storage of blood and blood components at prescribed temperatures, provide separate quarantine facilities for suspected blood units, and follow laid-down procedures for labelling blood bags, maintaining records for the stipulated period and preparing blood components in line with standard operating procedures. They must conduct regular self-audits to check compliance.

The FDA has directed all blood centres in Maharashtra to immediately review their existing practices and take the necessary corrective steps in line with the order for uniform compliance with the rules.

- Ends