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Maha FDA asks blood banks to submit license renewal applications by Dec 31, 2016
Shardul Nautiyal, Mumbai | Saturday, December 3, 2016, 08:00 Hrs  [IST]

Maharashtra FDA has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31 December, 2016 to carry out timely inspections and approvals.

According to 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.

There are around 53 blood banks in the state for which renewals are pending. Renewals for civic run blood banks at KEM Hospital, Lower Parel, LTMG Hospital, Sion, Rajawadi Hospital, Ghatkopar, Bhabha Hospital, Bandra and Bhagwati Hospital, Borivali are currently in the process of getting renewed.

“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 applications with FDA recommendations have to be submitted to the Drug Controller General of India (DCGI) for further approval,” said a senior FDA official.    

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 Central Drug Standard Control Organisation (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.

Maharashtra FDA has conducted inspections on 15 civic run blood banks in the past three months in Mumbai. Based on the inspections, it suspended licenses of four municipal blood banks and canceled license of one of them. There are around 60 blood banks in the city.

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.

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