Maharashtra Food and Drug Administration Minister Girish Bapat has suggested the Maharashtra Food and Drug Administration (FDA) to be considerate while issuing closure notices after inspecting the city blood bank premises 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 problem to avert suspensions of licenses in the worst-case scenario.

This comes close on the heels of the state FDA recent crackdown on 4 civic-run hospitals recently for failing to appoint blood transfusion officers (BTOs) in violation of Drugs and Cosmetics Act, 1940. BTOs are responsible for supervising as well as looking into aspects involving transfusion reaction, grouping and cross matching of blood.  

City based blood banks have been facing practical difficulties in putting in place adequate manpower and an assurance on the same from the FDA Minister comes as a big relief from the abrupt closure the blood banks may face for non -compliance to Drugs and Cosmetics Act, 1940 from the state regulator any time during or after the inspections.

According to officials associated with the development, KEM Hospital is one such hospital which have been facing the difficulty in appointing the staff unlike a hospital like Tata Memorial Hospital known for the best cancer treatment in the country which boasts of adequate staff to take care of the blood collection of over 20,000 units of blood in a year. KEM alone has a huge collection of 30,000 units annually.  

In its routine inspections, the state regulator had taken cognizance of the absence of requisite number of BTOs at these banks, besides other technical deficiencies such as non-calibration of equipment.

As per rules, a 24/7 blood bank is required to have at least three 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.

The crackdown on blood banks as per a senior FDA official is under the premise that BTO posts in civic run hospital blood banks have been lying vacant for quite some time now.

As per official reports, 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.

As per Schedule ‘F’, Part XII-B and/or XII-C, 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.