Following Maharashtra Food and Drug Administration (FDA) serving show cause notice on Bhabha Hospital blood bank for non-compliance to the Drugs and Cosmetics Act, 1940 in terms of staff strength, the state regulator has detected cases of non-compliance in other civic run hospitals like KEM and VN Desai Hospital and is planning a crackdown on other hospitals through inspections.
Meanwhile, alarmed with FDA’s action, blood banks in the city are planning to approach food and civil supplies minister Girish Bapat demanding proper implementation of the D&C Act. A circular has also been sent from the FDA minister office suggesting all the blood banks in the city to report their grievances for its effective redressal.
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. BTOs are responsible for supervising as well as looking into aspects involving transfusion reaction, grouping and cross matching of blood.
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. The blood bank at Bhabha Hospital was asked to respond to a personal hearing based on the notice served by the Maharashtra FDA as the blood bank was functioning without a single BTO, according to a senior FDA official.
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.
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.
Suspensions and cancellations had been made in the past for violation of the provisions of Drugs & Cosmetics (D&C) Act as the blood banks failed to operate efficiently due to lack of technically qualified staff and was also found faltering in terms of maintaining a register of work done duly signed by a medical officer to successfully accomplish the operations of a blood bank.
Maharashtra Food and Drug Administration (FDA) had suspended the licenses of 7 blood banks and cancelled one based on 369 inspections done during 2013-14 alone across Maharashtra. The state has 303 blood banks and 3 cord blood banks.