Maharashtra FDA asks blood banks to address issues related to inadequate staff urgently

Against the backdrop of non-compliance of blood banks over inadequate staff, the Maharashtra Food and Drug Administration (FDA) has asked all the blood banks in the city to augment manpower to its optimum level following inspections carried over a period of six months.

“It has been observed that civic run blood banks have taken cognizance on issues related to manpower like frequent, unplanned and abrupt transfers of staff to other blood banks without taking due consideration leading to shortage of manpower in blood banks, which has now been looked into,” says a senior FDA official.

This comes at a time when the Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra FDA have started joint inspection of blood banks in an aggressive manner followed by compliance and verification visits in all the 59 blood banks of the city.

Joint inspections are conducted by a three-member committee comprising of CDSCO, drugs inspector, drugs inspector of FDA and an expert in the field, who oversee whether the blood bank has provided all the facilities or not.

Though civic run blood banks have faced suspension orders following such inspections over a period of six months, the inspections have yielded results in the form of approvals for license renewal for 33 blood banks from the Drugs Controller General of India (DCGI). This is a major boost to the blood banks in Maharashtra as the approvals for renewals have been received much before the expiry of licenses.

FDA has planned joint Inspections for rectifying errors on the part of the blood banks such as shortage of doctors, unavailability of equipment.

Civic run blood banks were also served show-cause notices last year for violation of Drugs and Cosmetics Act for issues ranging from not filling up positions of the Blood Transfusion Officers (BTO) and technicians at BMC run hospital blood banks for almost a year in some cases.

As per the Rules, a 24/7 blood bank is required to have at least three Blood Transfusion Officers  working in shifts.

As per the Drugs and Cosmetics Rules, 1945, blood bank licenses are valid for five years. CDSCO renews licences after the state FDA recommends the same for renewal.

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