Following the closure of two blood centres in Mumbai for serious violations of regulations, the Maharashtra State Blood Transfusion Council (SBTC) has ordered inspection of all government and private blood centres in the state.
SBTC director Dr Suhas Mohanalkar has directed blood transfusion officers to inspect every blood centre in the state and recommend action against those violating norms.
The Maharashtra Food and Drug Administration (FDA) had issued an immediate ‘stop work’ order on the state’s largest blood bank located within the state-owned JJ Hospital complex in Mumbai for serious violations of blood safety norms.
A similar order resulted in the shutdown of a private, Maya blood centre in Badlapur, an extended suburb. The action follows a joint inspection conducted along with the Central Drugs Standard Control Organisation (CDSCO) last week.
“The Food and Drug Administration will not tolerate any negligence or violation of rules affecting the health of blood donors and patients,” its commissioner Tukaram Mundhe, told the media in Mumbai. “All blood banks in the state must strictly comply with the law, failing which stringent regulatory action will follow. We are committed to ensuring that citizens receive safe blood.”
At the Sir J J Metropolitan Blood Centre, inspectors came across deficiencies in the storage and control systems for blood and blood components, besides improper handling of reactive and expired blood bags, shortcomings in the disposal of biohazardous material, malfunctioning equipment, and absence of essential sterilisation controls in the blood component preparation section.
The Badlapur centre revealed absence of mandatory records relating to the transportation of blood collected during camps, deficiencies in the traceability of blood bags, absence of a blood transfusion officer, expired equipment calibration, lack of quality control testing, irregularities in biomedical waste management, and the absence of mandatory approvals and records for blood donation camps.
In May, the CDSCO, the apex drug regulator in the country, had directed all 4,200 licensed blood centres to enrol in a national digital portal, after instances of HIV infections in children due to contaminated transfusions were reported.
The CDSCO decided to generate a database of all blood centres on the Online National Drug Licensing System portal “to strengthen regulatory oversight, enhance transparency in blood services, and ensure easy public access to blood and its components across the country.”
Many children tested positive for HIV after transfusions in Rajasthan, Madhya Pradesh, Jharkhand and Assam. In Gujarat, the Ahmedabad rural police arrested a few people who had blood banks in Maharashtra for their role in a spurious plasma racket.
The police had seized over a thousand units of adulterated blood plasma and arrested them. The police launched a probe after over 550 of 1,670 units of plasma bought from five blood banks in Maharashtra by a pharmaceutical company were found to be spurious.
Recently, the SBTC had warned blood banks in Maharashtra from collecting excess blood and transferring it in bulk to other states for profit. “Blood centres found violating SBTC guidelines, engaging in bulk transfers or profit-oriented practices will face strict action,” Dr Purushottam Puri, assistant director of the council, told reporters.
“Recommendations will be made to the Food and Drug Administration for cancellation of licences of such centres," Puri undescored.
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