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CDSCO, Maha FDA joint inspections to fix lacunae at blood banks over inadequate staff and equipment

Shardul Nautiyal, Mumbai
Saturday, May 06, 2017, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra Food and Drug Administration (FDA) are  planning to commence joint inspections of blood banks followed by compliance and verification visits in all the 59 blood banks of the city.

“Joint Inspections have been planned to be expedited for rectifying errors on the part of the blood banks such as shortage of doctors, unavailability of kits to test antibodies and other equipment related issues. It has been observed that civic authorities have taken cognizance on the operational issues only after an FDA inspection or notice for compliance on staff and infrastructure,” says a senior FDA official.

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, drugs inspector of FDA and an expert in the field, conducts joint inspection and sees whether the blood bank 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.

As per the Drugs and Cosmetics Rules, 1945, blood bank licenses are valid for five years. CDSCO renews licences after the state FDA recommends the same for renewal.

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.

The FDA had issued showcause notices last year on civic run blood banks for violation of several sections of the Drug and Cosmetics Act. It had asked the BMC to fill up the positions of the BTO and technicians. The banks did not have the required staff for almost a year in some cases. Also, the ELISA reader, which is bare minimum necessity in a blood bank for complete testing blood samples for HIV and other infectious diseases was missing.

Though civic run blood banks have faced suspension orders following such inspections over a period of six months, the inspections have yielded results in the form of approvals for license renewal for 33 blood banks from the Drug Controller General of India (DCGI). 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.

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.

 

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