As part of its ongoing crackdown on blood banks in the city towards non-compliance, Maharashtra Food and Drug Administration (FDA) has canceled license of Mulund-based MT Agarwal Hospital for non-compliance to Drugs Act. Following which the blood bank has been closed and now it would be converted into a blood storage centre.

This comes close on the heels of FDA issuing suspension orders on blood banks of 4 civic run hospitals for non-compliance. Of these blood banks, KEM Hospital and Nair Hospital blood banks have however managed to get stay from the FDA minister to avert any abrupt closure.

The 4 civic run hospitals also include VN Desai Hospital and Bhabha Hospital. 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.

As per sources, 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 has come as a big relief for the blood banks from facing an abrupt closure.

The state FDA minister is the appellate authority for hearing such cases and delivering the final verdict.

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 of the concerned blood bank.

In its routine 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.

Maharashtra FDA minister had also issued a circular suggesting the state 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.

Schedule ‘F’, Part XII-B and/or XII-C of Drugs and Cosmetics Act, 1940 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.