Maharashtra FDA introduces uniform compliance norms for licensed blood centres across the state

The Maharashtra Food and Drug Administration FDA has issued a comprehensive compliance order for all licensed blood centres and blood storage centres across the state introducing uniform operational and regulatory standards aimed at strengthening blood safety quality control and compliance with existing lawsThe order issued for the first time for all licensed blood centres and blood storage facilities in Maharashtra directs centres to strictly adhere to the provisions of the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 The move is intended to improve regulatory compliance while safeguarding the interests of blood donors and patientsAccording to the FDA human blood and its components are classified as a drug under the Drugs and Cosmetics Act 1940 Consequently no institution can collect process store or distribute blood without a valid licence Licensed blood centres are also required to comply with all statutory provisions prescribed under Schedule F Part XIIB of the Drugs and Cosmetics Rules 1945Inspections prompted statewide compliance orderThe FDA said the order follows inspections of certain blood centres where instances of noncompliance with statutory requirements under Schedule F Part XIIB of the Drugs and Cosmetics Rules 1945 were observed The directive seeks to ensure uniform implementation of regulatory standards across MaharashtraThe compliance order outlines operational requirements covering infrastructure staffing donor selection blood collection mandatory screening of blood and blood components component preparation storage labelling record management quality control biomedical waste management blood donation camps transportation of blood and daily reporting on the eRaktKosh portalKey operational requirementsUnder the order blood centres must maintain infrastructure prescribed under Schedule F Part XIIB including counselling rooms quality control units and blood component processing facilities Centres are also required to appoint qualified medical officers technical supervisors blood bank technicians nurses and counsellors in accordance with statutory requirementsThe FDA order mandates strict implementation of the revised 2020 donor selection criteria including temporary and permanent donor deferral norms Every unit of blood collected must undergo mandatory screening for HIV Hepatitis B Hepatitis C syphilis and malaria before being cleared for useBlood and blood components must be stored at prescribed temperatures with proper cold chain maintenance while suspected units must be kept in separate quarantine facilities The order also requires blood bags to be labelled in accordance with regulatory standards records to be maintained for the prescribed duration and standard operating procedures to be followed during blood component preparationIn addition all blood centres have been instructed to conduct regular selfaudits to monitor compliance with prescribed proceduresGuidelines for blood donation campsThe compliance order also prescribes operational standards for organising blood donation camps Centres must ensure adequate manpower appropriate equipment emergency medical facilities proper transportation arrangements and postcamp reporting mechanismsBlood centres have also been directed to update blood stock and related information on the eRaktKosh portal every day to improve transparency and availability of informationThe FDA has instructed all licensed blood centres in Maharashtra to review their existing procedures and implement corrective measures wherever necessary It has warned that failure to comply with the order may invite legal action under the applicable provisions of the Drugs and Cosmetics Act and RulesMaharashtra FDA Commissioner Tukaram Mundhe said Safe and assured healthcare is a fundamental right of every citizen Blood is an essential requirement for every patient Every blood donor and every patient in need of blood has the right to receive safe quality and reliable blood and blood componentsHe added Through this comprehensive order we aim to ensure uniform standards transparency quality control and legal compliance across all licensed blood centres in the state All licensed blood centres should implement the provisions of this order