Legal and ethical issues in safe blood transfusion.

Legal issues play a vital role in providing a framework for the Indian blood transfusion service (BTS), while ethical issues pave the way for quality. Despite licensing of all blood banks, failure to revamp the Drugs and Cosmetic Act (D and C Act) is impeding quality. Newer techniques like chemiluminescence or nucleic acid testing (NAT) find no mention in the D and C Act. Specialised products like pooled platelet concentrates or modified whole blood, therapeutic procedures like erythropheresis, plasma exchange, stem cell collection and processing technologies like leukoreduction and irradiation are not a part of the D and C Act. A highly fragmented BTS comprising of over 2500 blood banks, coupled with a slow and tedious process of dual licensing (state and centre) is a hindrance to smooth functioning of blood banks. Small size of blood banks compromises blood safety. New blood banks are opened in India by hospitals to meet requirements of insurance providers or by medical colleges as this a Medical Council of India (MCI) requirement. Hospital based blood banks opt for replacement donation as they are barred by law from holding camps. Demand for fresh blood, lack of components, and lack of guidelines for safe transfusion leads to continued abuse of blood. Differential pricing of blood components is difficult to explain scientifically or ethically. Accreditation of blood banks along with establishment of regional testing centres could pave the way to blood safety. National Aids Control Organisation (NACO) and National Blood Transfusion Council (NBTC) deserve a more proactive role in the licensing process. The Food and Drug Administration (FDA) needs to clarify that procedures or tests meant for enhancement of blood safety are not illegal.