Maharashtra Blood Centres Directed to Enforce Strict Safety Norms After FDA Order
The State Blood Transfusion Council (SBTC) has directed all blood centres and blood storage centres across Maharashtra to strictly comply with statutory requirements governing the collection, testing, storage, and distribution of blood. The directive follows a comprehensive compliance order issued by Maharashtra Food and Drug Administration (FDA) Commissioner Tukaram Mundhe.
Circulated to facilities across the state, the directive mandates strict implementation of provisions under Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945. The enforcement measure comes after FDA inspections uncovered instances of non-compliance at several blood centres.
Under the order, all centres must maintain standard infrastructure, including counselling rooms, quality-control facilities, and blood component processing units. Facilities are also required to employ qualified personnel as mandated by the rules, including medical officers, technical supervisors, blood bank technicians, nurses, and counsellors.
The FDA instructed centres to adhere strictly to the revised 2020 donor-selection and donor-deferral criteria. Every collected blood unit must undergo mandatory screening for HIV, hepatitis B, hepatitis C, syphilis, and malaria before being cleared for transfusion. In addition, centres must ensure an uninterrupted cold chain at prescribed temperatures, while keeping suspected or reactive blood units isolated in quarantine.
Facilities are further required to follow proper labelling procedures, preserve mandatory records, conduct regular self-audits, adhere to standard operating procedures for component preparation, and upload daily updates to the central e-RaktKosh portal.
The heightened scrutiny follows regulatory action taken earlier this year. In June, the FDA suspended operations at Sir J.J. Metropolitan Blood Centre in Mumbai and Maya Blood Centre in Badlapur after a joint inspection with the Central Drugs Standard Control Organisation (CDSCO) revealed critical lapses. Deficiencies identified at the time included the improper handling of reactive and expired blood bags, inadequate biomedical waste management, issues with quality-management systems, and gaps in mandatory staffing and records.
Because human blood and its components are classified as drugs under the Drugs and Cosmetics Act, all institutions involved in collecting, processing, storing, or distributing them must hold valid licences. The order warned that blood centres failing to meet the statutory requirements will face regulatory and legal action.
