Maharashtra Food and Drug Administration (FDA) has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31st December 2016 to carry out timely inspections and approvals. There are around 53 blood banks in the state for which renewals are pending.

As stated in Drugs and Cosmetics Rules, 1945 blood bank licenses are valid for 5 years. Central Licensing Approving Authority of Central Drugs Standard Control Organization (CDSCO) renews licences after the state FDA satisfies and recommends the same for renewal for further approval from the DCGI.

FDA senior official said “All the blood banks for which licenses are about to expire on 31st December 2016 have been directed to submit the license renewal applications to avoid delays in approvals and cancellations. The applications with FDA recommendations have to be submitted to the DCGl India for further approval,”

A committee comprising CDSCO -drugs inspector, FDA -drugs inspector and an expert in the field, conducts a joint inspection and sees whether the management or organization has provided all the facilities or not. The inspection must be done within 6 months after the expiry date of the licence as per the norms.

Licences are valid for 5 years, it is important that joint inspections to be carried out by FDA and CDSCO help eliminate errors. This inspections rule out the errors on the part of the blood banks such as shortage of doctors or 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.

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 maintain adequate technical staff as specified in the law.

Maharashtra Food and Drug Administration (FDA) has conducted inspections on 15 civic run blood banks in the past 3 months in Mumbai. Based on the inspections, it suspended licenses of 4 municipal blood banks and canceled license of one of them. There are around 60 blood banks in the city.

PHARMABIZ

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