State to form a high-powered panel as the FDA begins inquiries into bulk plasma transfers by blood banks
The Maharashtra government is set to overhaul the regulation of bulk plasma transfers after Mumbai Mirror’s investigation exposed alleged irregularities in the movement of plasma between blood banks. The investigation also raised questions about whether the existing regulatory framework provides adequate transparency, traceability and oversight.
As part of the proposed reforms, the state will constitute a high-powered committee immediately after the ongoing Assembly session to frame a comprehensive regulatory framework for bulk plasma transfers. The decision has yet to be formally notified. Simultaneously, the Food and Drug Administration (FDA) will begin inquiries into bulk plasma stock transfers undertaken by blood banks, signalling tighter enforcement across the sector.
Confirming the development to Mumbai Mirror, Dr Suhas Mohnalkar, Assistant Director of the State Blood Transfusion Council (SBTC), said the committee would comprise representatives from the FDA, Central Drugs Standard Control Organisation (CDSCO), National Blood Transfusion Council (NBTC) and the SBTC.
“The committee will be constituted after the Assembly session. Its mandate will be to develop a robust mechanism for regulating bulk plasma transfers and strengthen documentation,” Dr Mohnalkar said.
The committee will review the existing regulatory framework, identify procedural gaps and recommend a uniform system for monitoring plasma movement across Maharashtra. It is expected to formulate standard operating procedures covering documentation, stock reconciliation, reporting requirements, inspection protocols and accountability mechanisms.
A key objective will be to ensure complete traceability of plasma from the originating blood bank to its destination through standardised documentation and enhanced regulatory reporting.
Probe prompts action
Mumbai Mirror’s investigation highlighted concerns over plasma movement, documentation practices and regulatory monitoring, prompting discussions within the government on strengthening oversight. The report also questioned whether the current framework provides adequate safeguards to ensure every transfer is transparent, traceable and compliant with applicable norms.
Sources in the regulatory establishment said the findings also prompted discussions on improving coordination among agencies responsible for regulating blood banks and blood components. Officials said the move reflects growing recognition that effective oversight requires closer coordination between multiple authorities. Although blood banks are regulated under the Drugs and Cosmetics Act and Rules, enforcement responsibilities are shared among different agencies. They believe the proposed committee will help create a common regulatory platform and ensure uniform implementation of compliance standards.
FDA inquiries and focused traceability
Alongside the committee’s work, FDA will examine bulk plasma stock transfers undertaken by blood banks. According to Dr Mohnalkar, the inquiries will assess whether transfers complied with regulatory requirements, whether mandatory records were maintained and whether statutory procedures governing plasma movement were followed. Inspections are expected to include verification of inventory records, transfer documentation, stock reconciliation and compliance with licensing conditions.
Experts in transfusion medicine say bulk plasma transfers require rigorous documentation because plasma is a critical component of the blood supply chain and may be used for clinical purposes or processed into plasma-derived medicinal products. They say transparent record-keeping and periodic audits are essential to maintain public confidence in the blood transfusion system and safeguard the integrity of donated blood components.
Officials said the recommendations are expected to strengthen Maharashtra’s regulatory architecture without disrupting legitimate medical or manufacturing requirements.
