Maharashtra’s State Blood Transfusion Council has directed blood centres and storage facilities to strictly follow FDA norms on collection, testing, storage and distribution. The move follows inspections that found compliance gaps, while two centres faced regulatory action in June. The order also mandates screening, cold-chain maintenance, records and quality controls.

The Maharashtra SBTC has tightened compliance requirements for blood collection, testing, storage and distribution centres across the state | AI Generated Representational Image

Mumbai, August 26, 2026: 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, following a comprehensive compliance order issued by the Maharashtra Food and Drug Administration (FDA).

Through a communication issued last week, the SBTC circulated the compliance order issued by FDA Commissioner Tukaram Mundhe to all blood centres and storage centres. The directive requires strict implementation of provisions under Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945.

Uniform Compliance Requirements

The move comes after FDA inspections found instances of non-compliance at blood centres. The order lays down uniform requirements covering infrastructure, manpower, donor selection, blood collection, mandatory testing, component preparation, storage, labelling, record maintenance, quality control, biomedical waste management, transportation and blood donation camps.

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Under the directive, centres must have prescribed infrastructure, including counselling rooms, quality-control facilities and arrangements for processing blood components. They are also required to appoint qualified medical officers, technical supervisors, blood bank technicians, nurses and counsellors as mandated under the rules.

The FDA has further directed centres to strictly follow the revised 2020 donor-selection and donor-deferral criteria. Every collected blood unit must be screened for HIV, hepatitis B, hepatitis C, syphilis and malaria before it is released for transfusion.

Blood and blood components must be maintained at prescribed temperatures with an uninterrupted cold chain, while suspected or reactive units have to be kept separately in quarantine.

Stricter Monitoring Of Blood Centres

The order also stresses proper labelling of blood bags, preservation of mandatory records, adherence to standard operating procedures for component preparation, regular self-audits and daily updating of information on the e-RaktKosh portal.

The stricter monitoring follows regulatory action against blood centres earlier this year. In June, the FDA suspended operations at Sir J.J. Metropolitan Blood Centre in Mumbai and Maya Blood Centre in Badlapur following a joint inspection with the Central Drugs Standard Control Organisation (CDSCO).

The inspections found deficiencies including improper handling of reactive and expired blood bags, inadequate biomedical-waste management, problems with quality-management systems and equipment, and gaps in mandatory staffing and records.

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Regulatory Action For Non-Compliance

Human blood and its components are classified as drugs under the Drugs and Cosmetics Act, making a valid licence mandatory for institutions involved in their collection, processing, storage or distribution. The latest compliance order warns that centres failing to meet the prescribed statutory requirements could face regulatory and legal action.

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