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Gujarat FDCA cancels licenses of 15 blood banks for non-compliance to blood safety norms
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Shardul Nautiyal, Mumbai
March 31 , 2017
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In a major crackdown on blood banks in Gujarat for non-compliance,
Gujarat Food and Drug Control Authority (FDCA) has canceled licenses of
15 blood banks for not having proper staff, unavailability of kits to
test antibodies and other equipment related issues. There were a total
of 156 blood banks in the state out of which 141 are currently
functioning after the recent cancellations.
“Some of these
blood banks have been repeat offenders and that is why stringent actions
were warranted,” said Gujarat FDCA Commissioner Dr H G Koshia.
As
per the rules, a 24/7 blood bank is required to have at least three
Blood Transfusion Officers (BTOs) working in shifts. It is also
mandatory that collecting and transfusing of blood and its components,
such as plasma, white blood cells etc, be done in the presence of a BTO
to avoid fatal mistakes.
Schedule ‘F’, Part XII-B and/or XII-C of
Drugs & Cosmetics 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.
As
per the Drugs and Cosmetics Rules, 1945, blood bank licenses are valid
for five years. Central licensing approving authority of Central Drugs
Standard Control Organisation (CDSCO) renews licences after the state
Food and Drug Administration satisfies and recommends the same for
renewal.
While inspecting blood banks, drug inspectors look into
aspects like bio-safety in blood banks, donor management and good lab
practices. There are subjects like blood component preparation,
equipment, documentation, internal audit, environment and aspects
related to waste management which the drug inspectors have to touch upon
while inspecting a blood bank premises.
Gujarat FDCA had trained
45 drug inspectors on Good Distribution Practices (GDP) and Good
Laboratory Practices (GLP) through 22 online courses based on an MoU
signed with a foreign agency during Vibrant Gujarat Summit in January,
2015.
Done as a part of strategic partnerships for knowledge
sharing with foreign companies, training programmes for drug inspectors
are primarily conducted through an e-learning mode to help drug
inspectors get access to world-class training on par with global
counterparts.
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