Following FDA issuing show cause notices to 19 Mumbai based blood banks for overcharging, a representation has been made by the Federation of Bombay Blood Banks (FBBB) to the Maharashtra Food and Drug Administration (FDA) clarifying that increase in the cost of one unit of blood is due to inclusion of specialised test charges recommended by National Blood Transfusion Council (NBTC)

A reply from the state regulator is, however, awaited, a senior blood bank official informed. The state FDA had earlier also asked the State Blood Transfusion Council (SBTC) to revoke their no objection certificates (NOC) following the issuance of show case notices.

The Maharashtra FDA probe into 19 blood banks in the city had found that majority of them have been charging prices higher than the rates fixed by the NBTC. Around 16 blood banks were overcharging anywhere between Rs.50 and Rs.500. A government resolution in June 2014 had set Rs.1,450 as the price for one unit of whole blood, Rs.400 for fresh frozen plasma, Rs.400 for one unit of platelets and Rs.250 for cryoprecipitate.

In November last year, the FDA officials inspected 309 blood banks across the state, of which 72 were found to have discrepancies in charging process. Out of the 72 blood banks, 19 were from Mumbai alone.

In order to bring in more accountability towards making safer blood available at the point of care, Maharashtra FDA had also suspended the licenses of 7 blood banks and canceled one based on 369 inspections done during 2013-14 across Maharashtra. The state today has 303 blood banks and 3 cord blood banks.

Suspensions and cancellations were made for violation of the provisions of Drugs & Cosmetics (D&C) Act as the blood banks had failed to operate efficiently due to lack of monitoring by technically qualified staff. The blood banks were also found faltering in terms of maintaining a register of work done duly signed by a medical officer and compliance in terms of staff strength and instrumentation to successfully accomplish the operations of a blood bank.

Informs a senior FDA official, "Statutory action was taken against these 8 blood banks as they were found violating the provisions of Schedule F Part XII-B of Drugs and Cosmetics Act, 1940 and Rules 1945."

As per Schedule ‘F’, Part XII-B and/or XII-C, the applicant 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.

D&C Act also stipulates that the applicant shall provide adequate arrangements for storage of whole human blood, human blood components and blood products. The applicant shall furnish to the licensing authority, if required to do so, data on the stability of whole human blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.