The Ministry of Health and Family welfare has published Drugs and Cosmetics (Second Amendment) Rules 2020 to further amend the Drugs and Cosmetics Rules, 1945.
The Amendment is brought under chapter X B which deals with requirements for collection, storage, processing and distribution of whole human blood by blood bank and collection, processing, testing, storage and release of umbilical cord blood stem cells. The term blood bank as stated above shall be substituted with Blood Centres.
The Amendment defines the term Blood Centre as follows:
Blood Centre is an authorized premise in an organization or institution as the case may be, for carrying out all or any of the operations including collection, apheresis, processing, storage and distribution of blood drawn from donors or received from another licensed Blood Centre and for preparation, storage and distribution of blood components
The operation of Blood Centre or processing or both of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole time employee and who is Medical Officer, and possessing the prescribed qualification.
Further, the amendment prescribes the qualification for staffs conducting blood donation camps and the criteria for blood donation has been substituted.
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