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Maha FDA to issue checklist to blood banks for self-audit to address non compliance to D&C Rules

Shardul Nautiyal, Mumbai
Thursday, February 8, 2018, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) is planning to issue checklists  for self-audits over 300 blood banks in the state towards addressing non-compliance to drug rules.  The state regulator had suspended licenses of 12 blood banks in the state and canceled one license for non-compliance to drugs and cosmetics rules based on 122 inspections. Following these inspections, 43 show cause notices were served.

The FDA had issued show cause notices last year on civic run blood banks for violation of several sections of the Drug and Cosmetics Act. It had asked the BMC to fill up the positions of the BTO and technicians. The banks did not have the required staff for almost a year in some cases. Also, the ELISA reader, which is bare minimum necessity in a blood bank for complete testing blood samples for HIV and other infectious diseases was missing.

The Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra FDA also made joint inspections of blood banks followed by compliance and verification visits in all the 59 blood banks of the city.

This comes close on the heels of similar self-audit exercises being done by drug manufacturers and 80, 000 drug retailers across the state.

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.

As per the Rules, a 24/7 blood bank is required to have at least three blood transfusion officers (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.

A committee comprising CDSCO drugs inspector, drugs inspector of FDA and an expert in the field, conducts joint inspection and sees whether the blood bank has provided all the facilities or not.

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.

Though civic run blood banks had faced suspension orders following such inspections in the past, inspections have yielded results in the form of approvals for license renewal for almost all blood banks from the Drug Controller General of India (DCGI).


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