Maharashtra Food Regulator Issues First Rulebook For Blood Banks

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

Human blood and its components are notified as a "drug" under the Drugs and Cosmetics Act, 1940. Accordingly, no blood centre or institution is permitted to collect, process, store or distribute blood without a valid licence, he said.

Every blood centre is required to comply with all statutory requirements prescribed under the Drugs and Cosmetics Rules, 1945, Mundhe said.

The guidelines deal with 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.

During inspections of certain blood centres, it was observed that the statutory requirements were not being fully complied with. Therefore, the order was issued to ensure effective and uniform implementation of these provisions across the state, said Mundhe.

Blood banks must ensure the availability of infrastructure including counselling rooms, quality control facilities, and blood component processing facilities, the order said.

They should also have qualified medical officers, technical supervisors, blood bank technicians, nurses, and counsellors in accordance with the prescribed norms.

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

It should ensure proper storage of blood and blood components at prescribed temperatures, provide separate quarantine facilities for suspected blood units, and comply with prescribed procedures for labelling blood bags, maintaining records for the stipulated period, and preparing blood components in accordance with standard operating procedures.

It should conduct regular self-audits to verify compliance.

The FDA has directed all blood centres in the state to immediately review their existing practices and implement the necessary corrective measures in accordance with this order.

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