Section 122EA(1) in The Drugs and Cosmetics Rules, 1945
(1)In this Part and in the Forms contained in Schedule A and in Part XII-B and Part XII-C of Schedule F, unless there is anything repugnant in the subject of context,-(a)"apheresis" means the process by which blood drawn from a donor, after separating plasma or platelets or leucocytes, is retransfused simultaneously into the said donor;(b)"autologous blood" means the blood drawn from the patient for re-transfusion into himself later on;(c)"blood" means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant;(d)"blood bank" means a place or organisation or unit or institution or other arrangements made by such organisation, unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components;(e)"blood component" means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor;(f)"blood product" means a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors;(g)"donor" means a person who voluntarily donates blood after he has been declared fit after a medical examination, for donating blood, on fulfillling the criteria given hereinafter, without accepting in return any consideration in cash or kind from any source, but does not include a professional or a paid donor;Explanation. - For the purposes of this clause, benefits or incentives like pins, plaques, badges, medals, commendation certificates, time-off from work, membership of blood assurance programme, gifts of little or intrinsic monetary value shall not be construed as consideration.(h)"leucapheresis" means the process by which the blood drawn from a donor, after leucocyte concentrates have been separated is re-transfused simultaneously into the said donor;(i)"plasmapheresis" means the process by which the blood drawn from a donor, after plasma has been separated, is re-transfused during the same sitting into the said donor;(j)"plateletpheresis" means the process by which the blood drawn from a donor, after platelet concentrates have been separated, is re-transfused simultaneously into the said donor;(k)"professional donor" means a person who donates blood for a valuable consideration, in cash or kind, from any source, on behalf of the recipient-patient and includes a paid donor or a commercial donor;(l)"replacement donor" means a donor who is a family friend or a relative of the patient-recipient.]
