Maharashtra Blood Centres Ordered to Follow FDA Norms

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. This move comes after FDA inspections found instances of non-compliance at blood centres.

The directive requires strict implementation of provisions under Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945. 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.

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.

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.

The FDA's move is aimed at ensuring the safety and quality of blood and blood components in the state. 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 State Blood Transfusion Council has circulated the compliance order to all blood centres and storage centres, warning them of strict action in case of non-compliance. The order is a significant step towards ensuring the safety of patients who receive blood transfusions in Maharashtra.

The FDA's action is also expected to improve the overall quality of blood banks in the state, which is crucial for patient care. With the implementation of these new guidelines, blood centres and storage centres will be required to maintain high standards of quality and safety, which will ultimately benefit patients who rely on blood transfusions.

In conclusion, the Maharashtra FDA's directive is a welcome move towards ensuring the safety and quality of blood and blood components in the state. The stricter monitoring and enforcement of regulations will help to prevent instances of non-compliance and ensure that patients receive safe and high-quality blood transfusions.

The move is significant for Maharashtra, which has a large number of blood banks and storage centres. The state's population relies heavily on these institutions for blood transfusions, and it is essential that they maintain high standards of quality and safety. With the FDA's directive, the state is taking a crucial step towards ensuring the safety of patients who receive blood transfusions.

Overall, the FDA's action is a positive development for patient care in Maharashtra, and it is expected to have a significant impact on the quality of blood banks in the state.