Applications for renewal of licenses of civic run blood banks at KEM Hospital, Bhagwati Hospital, Borivali and Rajawadi Hospital, Ghatkopar have been sent to the Drug Controller General of India (DCGI) office for approval after Maharashtra Food and Drug Administration (FDA) inspections.

This is followed by Maharashtra FDA directive to 306 blood banks in the state to submit applications of renewal of licenses by December 31, 2016.

There are 53 blood banks in the state for which renewals have been pending. Renewals for civic run blood banks LTMG Hospital, Sion and Bhabha Hospital, Bandra are currently in the process of being sent for further approval to the DCGI.

The state FDA has taken up the task of renewal of pending licenses in an aggressive manner and has instructed the 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 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 for further approval from the DCGI.

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.

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.     

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.

Licences are valid for five years, it is important that joint inspections to be carried out by FDA and CDSCO help eliminate errors. Joint 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.

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.