Maharashtra Food and Drug Administration (FDA) is planning to launch a massive crack down on illegally operating cord blood banks in the state following an inspection on Sangli based cord blood bank Stem Plus Biotech. The cord blood bank found was operating without a license and lack of facilities in contravention to provisions of Drugs and Cosmetics Act.
FDA is now planning to lodge an FIR against the unauthorised cord blood bank for illegally operating for two years and cheating 48 customers. According to FDA officials, Sangli based Stem Plus Biotech was operating without a license in contravention to Section 18 C of Drugs and Cosmetics Act based on the inspection carried on August 23, 2014. There are three registered cord blood banks in the state as of today.
According to the FDA inspection report, owner of the bank was operating the unit without following proper protocols in terms of collection, processing, testing and storing of stem cells. Explains a senior FDA official, "We are planning to take a serious view of such illegally operating blood banks as it is a unique case in which a big amount of money has been extracted from around 48 customers by purportedly misleading them into giving samples. Each customer was forced to pay Rs. 45,000 to Rs. 65,000 without following proper documentation and authentication after the samples were drawn."
The owner was found violating the provisions of D&C Act as the cord blood bank lacked monitoring by technically qualified staff and instrumentation to successfully accomplish its operations.
"Acting on a tip-off, officers from Maharashtra FDA visited the centre presenting themselves as clients willing to invest in cord blood banking. Statutory action will be taken against the blood bank in violation of the provisions of Schedule F Part XII-D of Drugs and Cosmetics Act, 1940 and Rules 1945. The offender can be penalised ranging from imprisonment of three to five years and a fine of Rs. one lakh to a fine amounting to three times the money extracted from the gullible customers" the FDA official explains.
As per Schedule âFâ of the Act, the applicant should provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. 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.
"All the customers have been updated about the illegal operation and the FDA crackdown. Public support is being sought to curb such malpractices in the near future,"concludes an FDA official.