Regulation of Blood and Blood products in India, USA and EU

  • Swati Gupta Delhi pharmaceutical science and research university
  • Harvinder Popli


Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and invention in science and technology, yet we cannot make blood hence, human blood has no substitute. The availability of safe blood and blood products is essential for diverse modern healthcare services including some surgeries, treatments for cancer, chronic medical conditions, trauma care, organ transplantation, and childbirths that ultimately improve life for millions of patients who are need of transfusion annually. We do not have yet well-defined and stringent regulatory framework for blood products regulation. Frailty may arise from the inability of governments to enforce laws, regulations, and policies and personnel who may not aware or cannot follow quality assurance and/ or good manufacturing practices. While the health sector in developed nation has made outstanding accomplishments in the past few decades. The study sheds on the overview of blood transfusion system in India and other developed nations. There were a mix of methodologies, including literature review (government documents), interviews with key officials in Indian Red Cross Society and analysis of data was used. Results of analysis showed that there are several areas that need to be addressed as it potentially affect the timely availability of safe blood products, which calls for strengthening the planning and monitoring of blood transfusion services.

Keywords: Transfusion medicine, blood transfusion, Transfusion transmitted infection (TTI)


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How to Cite
Gupta, S., and H. Popli. “Regulation of Blood and Blood Products in India, USA and EU”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 72-84, doi:10.22270/ijdra.v6i2.246.