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Shardul Nautiyal, Mumbai January 29 , 2019
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 ‘F’, 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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