RTI reveals year-long lapse in regulatory compliance; hospital blames bureaucratic delays
Mumbai :
In a startling revelation, ten staff members at Mumbai’s KEM Hospital blood bank were found to have been working without the required Food and Drug Administration (FDA) approval for the past year. The disclosure came through a Right to Information (RTI) query filed by activist Chetan Kothari.
Unqualified Personnel Included Lab Technicians and Medical Officers
The unapproved staff comprised eight lab technicians and two medical officers. KEM Hospital officials admitted to the lapse, noting that a similar issue had occurred previously, and blamed systemic delays in the approval process.
Safety and Accountability Concerns Raised
Hospital insiders warned that the absence of FDA approvals compromises patient safety and undermines accountability. “FDA approval is critical. Without it, disciplinary action is complicated if errors occur,” said a senior blood bank official.
Hospital Cites Administrative Roadblocks
KEM authorities claimed they had submitted multiple approval requests, most recently in January, but received no response. They pointed to challenges in the online application process and rigid Brihanmumbai Municipal Corporation (BMC) policies, including a six-month employment break rule designed to prevent claims for permanent jobs.
FDA Responds: Hospital at Fault for Incomplete Submissions
FDA officials contested the hospital’s claims, stating that only 12 applications had been received since 2021. Of these, six were rejected for inadequate qualifications, three approved, two were incomplete, and one lacked the mandatory fee payment.
The incident has intensified scrutiny of both the hospital’s hiring practices and the FDA’s approval system, highlighting a troubling gap in healthcare oversight.
