Subsequent to Maharashtra FDA receiving renewal approvals for 33 blood banks out of 59 from Drug Controller General of India (DCGI) for which licenses expired in December, 2016, Maharashtra FDA has directed blood banks for which licenses have expired in January 2017 and February 2017 to submit their license renewal applications to avoid delays in approvals and further cancellations.

The state FDA had instructed blood banks to complete their application modalities so that inspections can be carried out in a time -bound manner and approvals granted. As licences are valid for five years, it is important that inspections have to be carried out by FDA to help eliminate errors.

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.
Maharashtra FDA had earlier directive to all the blood banks for which licenses were about to expire on December 31, 2016 to submit their license renewal applications to avoid delays in approvals and cancellations.

Renewals for civic run blood banks at LTMG Hospital, Sion, KEM Hospital, Parel, St George hospital blood bank, JJ Hospital blood bank, Nair hospital blood bank, Bombay hospital blood bank, Breach Candy hospital blood bank, Lilavati Hospital, Bandra and Rajawadi Hospital, Ghatkopar have been approved by the DCGI among others.

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.

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. Inspection reports were sent recently to the DCGI office for approval after Maharashtra FDA inspections.

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.