Responding to an RTI query, KEM Hospital officials confirmed that their post-graduate students had been acting as medical officers of the blood bank. While this is a clear violation of the Drugs and Cosmetics Rules, 1945, which only allow certified pathologists to head blood banks, FDA notified hospital officials to inquire into the irregularity and take necessary action.
The Drugs and Cosmetics Rules, regulated by FDA officials across the state, necessitate that operation of a blood bank and/or processing of whole human blood for components/manufacture of blood product be carried out under active direction and personal supervision of component technical staff comprising at least one whole-time employee who is a medical officer.
The norms however allow post graduate (MD) degree holders in medicine, pathology and transfusion medicines departments. At the same time, even degree holders from the department, having adequate knowledge of blood group serology, blood group methodology and medical principles involved in procurement of blood and preparation of its components can be recruited for the same.
Data provided by the KEM Hospital blood bank revealed names of 11 resident doctors, designated to run the blood bank from 2010-2018. KEM Hospital officials also confirmed that they had been employing resident doctors for the job and not violating any rules. “The resident doctors have got FDA approval and it can be verified. Even the past PG students were approved by FDA and they have followed a proper channel of FDA Norms,” said Jayashree Sharma, HOD, transfusion medicine, KEM Hospital.
