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In a move aimed at strengthening blood safety and ensuring uniform regulatory compliance across Maharashtra, the Maharashtra Food and Drug Administration (FDA) has issued a comprehensive compliance order for all licensed blood centres and blood storage centres in the state. The directive lays down detailed standard operating procedures covering every stage of blood collection, testing, processing, storage and distribution, while warning of strict legal action against centres found violating statutory requirements.
The order, issued for the first time for all blood centres and blood storage centres across Maharashtra, seeks to ensure strict implementation of the provisions of the D&C Act, 1940, and the D&C Rules, 1945. It comes after inspections conducted by the FDA revealed that some blood centres had failed to fully comply with mandatory provisions prescribed under Schedule F, Part XII-B of the Rules, prompting the regulator to introduce a uniform compliance framework across the state.
Human blood and blood components are classified as "drugs" under the D&C Act, making it mandatory for every blood centre to obtain a valid licence before undertaking the collection, processing, storage or distribution of blood. The new order reiterates that all licensed centres must strictly adhere to statutory conditions governing infrastructure, personnel, quality systems and operational practices.
The comprehensive directive prescribes detailed requirements for blood centres, including adequate infrastructure, counselling facilities, quality control departments and blood component processing units in accordance with Schedule F, Part XII-B. It also mandates the appointment of qualified medical officers, technical supervisors, blood bank technicians, nurses and counsellors as specified under the regulations.
The order requires strict implementation of the revised donor selection and donor deferral criteria introduced in 2020. Every blood unit must undergo mandatory testing for HIV, hepatitis B, hepatitis C, syphilis and malaria before it is released for transfusion.
To preserve blood quality and patient safety, the FDA has directed all blood centres to maintain prescribed storage temperatures, ensure an uninterrupted cold chain and create separate quarantine arrangements for suspected blood units. The order also mandates proper labelling of blood units, adherence to approved procedures for blood component preparation and preservation of records for the prescribed duration under the law.
Recognising the need for continuous compliance, the regulator has instructed every blood centre to conduct regular self-audits to verify adherence to prescribed procedures and identify gaps for corrective action.
The directive also establishes detailed operational requirements for organising blood donation camps. Blood centres have been asked to ensure adequate manpower, equipment, emergency medical facilities, transportation arrangements for blood units and post-camp reporting systems. In addition, all centres must update blood stock levels and related information daily on the national e-RaktKosh portal to improve transparency and availability of blood inventory.
The FDA has directed all licensed blood centres in Maharashtra to immediately review their existing operational procedures and implement the necessary changes to comply with the new standards. It has cautioned that any failure to follow the order will invite strict regulatory action under the Drugs and Cosmetics Act and Rules.
Explaining the objective behind the initiative, Maharashtra FDA Commissioner Tukaram Mundhe said the order is intended to establish uniform standards of blood safety and regulatory compliance throughout the state.
"Safe and reliable healthcare is a fundamental right of every citizen. Blood is a fundamental need for every patient. Every blood donor and every patient in need of blood has the right to access safe, high-quality and reliable blood and blood components. Through this comprehensive order, we aim to ensure uniform standards, transparency, quality control and legal compliance across all blood centres in the state. All licensed blood centres must implement this order," Mundhe said.
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