Following Maharashtra Food and Drug Administration's suspension orders on blood banks of 4 civic run hospitals over non-compliance, the state regulator has now served stop sale notices to other two municipal hospital blood banks for non-compliance to Drugs Act.

KEM Hospital and Nair Hospital blood banks which were served suspension orders have managed to get stay from the FDA Minister thus averting any abrupt closure. The state FDA Minister is the appellate authority for hearing such cases and delivering the final verdict.

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.

According to a senior FDA official, “We have been inspecting 5 blood banks every month and more blood banks are likely to come under scanner if they fail to comply with the rules.” In its inspections, 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.

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 be done in the presence of a BTO to avoid fatal mistakes.

City based blood banks have however maintained that they have been facing practical difficulties in putting in place adequate manpower.

Crackdown on hospital blood banks comes at a time when Maharashtra FDA Minister has 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.

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. 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.