Mumbai: For the past year, 10 out of 21 staff members at KEM Hospital’s blood bank were working without the mandatory approvals from the Food and Drug Administration (FDA), according to information provided in response to a Right to Information (RTI) request.
The unapproved personnel included eight lab technicians and two medical officers, data from the RTI filed by activist Chetan Kothari revealed. Hospital officials acknowledged the situation, stating that a similar issue occurred in the past.

The lack of FDA approval raises serious concerns about accountability and regulatory oversight. “If someone commits a serious error, FDA approval ensures there is a system in place to take action, including withholding salaries,” said an official from the hospital’s blood bank.
According to the doctor, the hospital submitted several requests for staff approvals to the FDA, the most recent in January, but none were granted so far.
Ironically, the doctor noted, in cases of negligence, it is often the FDA-approved staff who are reprimanded, even when the error is committed by an unapproved colleague.
“Earlier, these approvals were obtained via hard copy, but now the process is entirely online. There has been no communication from the FDA regarding the delays. We believe the issue stems from the administrative framework for contractual posts within the BMC,” hospital officials said.
As per BMC policy, appointment orders for contractual employees include a mandatory one-day break every six months to ensure the service is not considered continuous—thus preventing claims for permanent employment.
FDA officials said, “We have only 12 applications from the hospital since 2021. Of that, six were rejected due to lack of required qualifications and 3 were granted. They have only filled the form for other two but have not sent them ahead for approval and there’s one more application for which the payment is pending from the hospital’s side.”