The Asian Age: Mumbai: Sunday,
May 15, 2016.
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.