Maharashtra Food and Drug Administration (FDA) has served show cause notices to 72 blood banks located in Greater Mumbai, Nashik, Konkan, Nagpur and Pune divisions for overpricing blood in violation of Article 47 of the constitution and Drugs and Cosmetics Act.
The current rate fixed for a blood unit by the government is Rs. 450 and notices served were meant to ensure that the blood banks comply with law of the land in the wider public interest. Show- cause notices were served based on the inspections carried between November 3 and November 5, 2014 across Maharashtra under the guidance of Commissioner FDA Purshottam Bhapkar.
The state has a total of 309 blood banks and the state regulator plans to bring in more accountability towards making safer blood available.
The notices served is the latest in the series of crackdown on blood banks in the past several months for non- compliance in terms of staff strength and hygiene. Blood banks of State run Cama Hospital and St George Hospital had submitted their compliance reports based on the action taken.
A stop operations notice was served to the blood bank at Cama Hospital based on a surprise inspection by the FDA and CDSCO officials. In their report, the inspection team stated that the blood bank and the serology and cross-matching room inside it was in an "extremely unhygienic" condition. Besides this, the blood bank was functioning without a single Blood Transfusion Officer (BTO).
As per 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.
As per FDA reports, the blood banks have failed to operate efficiently due to lack of monitoring by technically qualified staff and have exhibited non- compliance in terms of staff strength and instrumentation which is violation of Schedule F of Drugs and Cosmetics Act, 1940.
Suspensions and cancellations had been made for violation of the provisions of Drugs & Cosmetics (D&C) Act as the blood banks failed to operate efficiently due to lack of technically qualified staff and was also found faltering in terms of maintaining a register of work done duly signed by a medical officer to successfully accomplish the operations of a blood bank.
As per Schedule âFâ, 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.