As per the Drugs and Cosmetics Rules, 1945, blood bank licenses are valid for five years. Central licensing approving authority of Central Drugs Standard Control Organisation (CDSCO) renews licences after the state Food and Drug Administration (FDA) satisfies and recommends the same for renewal.
Inspection reports were sent recently to the DCGI office for approval after Maharashtra FDA inspections. This comes close on the heels of Maharashtra FDA directive to 306 blood banks in the state to submit applications of renewal of licenses by December 31, 2016.
All the blood banks for which licenses are about to expire on December 31, 2016 have been directed to submit the license renewal applications to avoid delays in approvals and cancellations.
The state FDA has taken up the task of renewal of pending licenses in an aggressive manner and has instructed blood banks to complete their application modalities so that inspections can be carried out in a time -bound manner and approvals granted.
As per the 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.
Before recommending, a three-member committee comprising CDSCO drugs inspector, drugs inspector of FDA and an expert in the field, conducts a joint inspection and sees whether the management or organisation has provided all the facilities or not. The inspection must be done within six months after the expiry date of the licence as per the norms.
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 licences are valid for five years, it is important that inspections have to be carried out by FDA to help eliminate errors. Inspections rule out the errors on the part of the blood banks such as shortage of doctors, unavailability of kits to test antibodies or other equipment related issues. In the absence of inspections, the blood banks will continue to function with loopholes.
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