The Food and Drug Administration (FDA) in Pune division has taken decisive action against city-based blood banks and blood centres, suspending licenses of 10 blood banks and eight blood centres following recent raids. The crackdown comes in response to several irregularities unearthed during surprise inspections, highlighting deficiencies in screening, testing, and operational protocols.
Rigorous Scrutiny Unveils Lapses
Girish Hukare, Joint Commissioner of FDA (Drug) in Pune division, highlighted the gravity of the situation, stating, “Licenses of 10 blood banks and eight blood centers have been suspended due to various irregularities uncovered during our inspections. The raids primarily targeted urban areas, and the decision to suspend licenses was based on the severity and recurrence of observed lapses.”
Stringent Regulations Since 2019
In an effort to enhance oversight and accountability, Maharashtra has imposed stricter regulations on the establishment of blood banks. Notably, the authority to grant no-objection certificates (NOC) was transferred from the State Blood Transfusion Council (SBTC) head to a governing body comprising senior officials from the public health department and FDA.
While the FDA serves as the primary licensing authority for blood banks, SBTC’s NOC remains a prerequisite, with licenses requiring renewal every five years. Under the Drugs and Cosmetics Act, 1940, the FDA’s drug department is empowered to conduct regular inspections and enforce compliance in blood banks and centres.
Identified Irregularities
Hukare elucidated various irregularities detected during inspections, ranging from minor discrepancies to potentially significant lapses. These include substandard quality of items, record-keeping discrepancies, procedural negligence in blood collection, testing, and charging excessive fees. Moreover, inadequate staffing and lack of requisite qualifications among personnel have compromised screening and testing processes.
SV Pratapwar, Assistant Commissioner of FDA (Drug), emphasized the importance of qualified medical personnel at blood donation camps. Instances of lapses were noted, prompting awareness sessions to reinforce compliance standards.
Qualifications of Technical Staff in Blood Banks
The FDA mandates specific qualifications for personnel in blood banks, ensuring proficiency and adherence to standard protocols. Medical officers, registered nurses, blood bank technicians, and technical supervisors must meet stringent educational and experiential requirements to uphold operational integrity and patient safety.
As the FDA intensifies its efforts to rectify systemic deficiencies and uphold regulatory standards, the paramount objective remains ensuring the integrity of blood banking practices and safeguarding public health.
