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Abstract

Framework for Regulatory Regulation of Blood and Blood Products in India, United States and Europe

Author(s): S. Shyamala, K. Sonia* and K. Manikandan
Department of Pharmaceutical Analysis, SRM Institute of Science and Technology, Kattankulathur, Kanchipuram 631501, Tamil Nadu, 1Department of Pharmaceutical Chemistry, Sri Ramachandra Faculty of Pharmacy, Sriher, Porur, Chennai 600116, India

Correspondence Address:
K. Sonia, Department of Pharmaceutical Analysis, SRM Institute of Science and Technology, Kattankulathur, Kanchipuram 631501, Tamil Nadu, India, E-mail: soniapharm68@gmail.com


Blood and blood (plasma) products amuse oneself a crucial function in existence of person’s life. In the approach of rigorous science and technology development there is no course of action to produce feigned bases of human blood, hence no substitute for human blood till now. Annually, the millions of patient’s lives are safeguard by modern health care services such cases like surgeries, cancer treatment, trauma, organ transplantation and during childbirth. The role of (Centre for biological evaluation and research) which was organized by Food and Drug Administration, the World Health Organization protects the public health by secure and supply of biological products whenever is needed and also provided expedient information about biological products. Evaluation criteria for national blood regulatory system “blood regulation network” that describes about divine rights and functions of integrated blood regulations. The interior consequence includes authorization of blood firm marketing, benchmark of clinical investigation, complete data regarding patient blood management. Though, the strict or precise regulatory framework is not yet provided. The corona virus disease-2019 epidemic has wreaked havoc on several countries health-care systems. The voluntary blood donation camps were discontinued due to early government measures such as widespread lockdown and restriction strategies toward public gatherings. This study examines the recorded regulatory guidelines in case of blood and blood products, in addition of hemovigilance, as set forth by the United States food and drug administration, the Europe, and India, as well as the scenario during corona virus disease-2019.

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