Civic run blood banks have managed to get stay from the FDA Minister Girish Bapat averting any abrupt closure following Maharashtra Food and Drug Administration (FDA) suspension orders on 4 civic run hospital blood banks over non-compliance. The state FDA Minister is the appellate authority for hearing such cases and delivering the final verdict.
“Blood banks have managed to get a stay on the suspension orders from the appellate authority and the case is pending untill the time it comes for hearing for the final verdict,” according to official sources.
Blood banks in the past have failed to operate efficiently due to lack of monitoring by technically qualified staff and have exhibited non- compliance in terms of staff strength and instrumentation which is violation of Schedule F of Drugs and Cosmetics Act, 1940.
Schedule ‘F’, Part XII-B and/or XII-C provisions that the applicant 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 provisions of the law, the blood banks can function after the issuance of suspension orders during the appeal period of three months, in which case they can appeal to the appellate authority to be heard in a judicious manner.
The state regulator had taken cognizance of the absence of requisite number of blood Transfusion Officers (BTOs) at these banks, besides other technical deficiencies such as non-calibration of equipment in its routine inspections.
City based blood banks have however maintained that they have been facing practical difficulties in putting in place adequate manpower and an assurance on the same from the FDA Minister has come as a big relief from the abrupt closure of the blood banks.
Maharashtra FDA Minister Girish Bapat had suggested the Maharashtra FDA to be considerate while issuing closure notices keeping in view of the difficulties faced by civic-run hospitals in maintaining adequate blood bank staff for its effective functioning.
The state FDA has, however, maintained that suspension orders on the blood banks detected for non-compliance is applicable after granting appeal period of 3 months which is sufficient amount of time to rectify the deficiency.