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DCGI grants renewal approvals for 48 blood banks out of 59 in Maharashtra

Shardul Nautiyal, Mumbai
Wednesday, May 17, 2017, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) has received approvals for license renewal for 48 blood banks from the Drug Controller General of India (DCGI) based on inspections carried across 59 blood banks licenses in Mumbai.

Approvals for renewals of most of the blood banks have been received much before the expiry of licenses. Inspection reports were sent recently to the DCGI office for approval after Maharashtra FDA inspections.

Maharashtra FDA had sent a 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.

As per the Drugs and Cosmetics Rules, 1945, blood bank licenses are valid for five years. Central Drugs Standard Control Organisation (CDSCO) renews licences after the state Food and Drug Administration (FDA) satisfies and recommends the same for renewal.

Renewals for Bombay Hospital blood bank, Breach Candy Hospital blood bank, Lilavati Hospital, Bandra, Rajawadi Hospital, Ghatkopar, LTMG Hospital, Sion, KEM Hospital, Parel, St George Hospital blood bank, JJ Hospital blood bank, Nair Hospital blood bank have been approved so far by the DCGI among others.

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 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 three-member committee comprising CDSCO drugs inspector, FDA 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.


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