Pune: Maharashtra Food and Drug Administration (FDA) has issued a comprehensive regulatory order for all licenced blood centres and blood storage facilities for the first time in the state, prescribing uniform procedures from donor selection and blood collection to testing, storage, transportation and distribution.The order was issued on Friday. It comes after inspections revealed that several centres were not compliant with statutory requirements under schedule F, part XII-B of the Drugs and Cosmetics Rules, 1945. FDA has warned that centres violating the provisions would face legal action. Human blood and its components are treated as drugs under the Drugs and Cosmetics Act, 1940.The FDA statement read: “No centre or institution can collect, process, store or distribute blood without a valid licence. All such facilities must maintain infrastructure prescribed under law — including counselling rooms, quality-control sections and facilities to process blood components.”The order provided detailed guidelines regarding essential infrastructure, trained and qualified manpower, donor selection, blood collection, mandatory testing of blood and components, component preparation, storage, labelling, record management, quality control, biomedical waste management, objectives and organisation of blood donation camps, safe transportation of blood, daily data updates on the eRaktKosh portal and compliance with other regulations.FDA commissioner Tukaram Mundhe said, “Safe and reliable healthcare is a fundamental right of citizens. Blood is a basic need for patients. Every donor and patient requiring blood has the right to access safe, high quality and reliable blood and components. We aim to ensure uniformity, transparency, quality control and regulatory compliance across all blood centres in the state through the comprehensive order. All licenced blood centres must implement the order.”Meanwhile, the order makes it mandatory for centres to appoint qualified medical officers, technical supervisors, blood bank technicians, nurses and counsellors. Revised donor-selection criteria issued in 2020, including temporary and permanent deferral conditions, must be implemented strictly.Each blood unit must undergo compulsory screening for HIV, hepatitis B, hepatitis C, syphilis and malaria. Centres have been directed to store blood and components at appropriate temperatures, maintain the cold chain and keep suspected blood units in separate quarantine areas to prevent accidental use.FDA has prescribed requirements for blood-bag labelling, retention of records for the stipulated period and adherence to standard procedures during component preparation. Centres must conduct regular self-audits to verify compliance with approved procedures.The order also covered blood donation camps. Organisers must ensure adequate manpower, equipment, emergency arrangements, safe transportation and a post-camp reporting system. Blood stock and related information must be updated daily on the eRaktKosh portal, enabling better monitoring of availability and distribution.The move is expected to strengthen accountability across Maharashtra’s blood banking network, reduce risks arising from lapses in testing, storage, documentation and distribution and protect public health statewide.
