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Shardul Nautiyal, Mumbai March 31 , 2017
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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