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Gujarat FDCA to train 50 state drug regulators on effectively auditing blood banks in the state
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Shardul Nautiyal, Mumbai
January 29 , 2019
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In order to equip drug regulators on effectively auditing 140 blood
banks in the state, the Gujarat Food and Drug Control Administration
(FDCA) would be training 50 senior drug inspectors and assistant
commissioners on national blood policy and compliance to norms as
provisioned in Schedule F Part XII B of Drugs & Cosmetics (D&C)
Rules.
Requirements such as accommodation, technical staff and
equipment for operation of blood bank are stipulated under Part XII B of
D&C Rules.
Besides the aspects like bio-safety in blood
banks, donor management and good lab practices (GLP), the regulators
will be equipped to ensure audit readiness of blood banks for compliance
to certain norms like blood must be inspected prior to transferring
from one facility to another or issuing for patients use.
Other
norms that need to be followed are proper labeling of the blood bag,
cross match report for abnormal antibodies, checking for haemolysis or
clot and proper sealing of the blood bag. There may be abnormal
coloration in the red cells or plasma which may occur due to a possible
bacterial contamination.
This drive is very much relevant as the
state regulator had detected three blood banks for violation of several
sections of the D&C rules in the past few months.
Blood
bank audits are meant to check whether blood components were issued
without tests, blood separation technique are reviewed to get desired
component quality, calibration or interpretation of ELISA results is
correct, SOPs are followed which includes blood storage and method of
controlling temperature, management of returned blood, quality control
of supplies and reagents, infected and expired blood destruction
process, apheresis procedure and records among others.
Schedule
âFâ, Part XII-B and/or XII-C of D&C Act, 1940 requires that the
blood banks shall provide adequate space, plant and equipment for any or
all the operations of blood collection or blood processing. It also
mandates to provide and maintain adequate technical staff as specified
in the law.
Human blood is covered under the definition of Drug
under Section 3(b) of D&C Act. Hence, it is imperative that blood
banks need to be regulated under the D&C Act and rules thereunder.
State drugs controllers are authorized to issue licenses for blood banks and inspect them as per the law of the land.
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