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ISSN 2063-5346
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MEDICINE VALIDATION AND IMPLEMENTATION OF STEM CELL THERAPY REGULATORY APPROVAL STATUS

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Raj Shekhar1*, P Muralidharan2 , Namrata Hallur3, SB Puranik4, Phatru Patel5, ABA Ahmed6
» doi: 10.48047/ecb/2023.12.si10.00256

Abstract

The stem cell therapy has a developing emerging field in the world and market rate in around 145.8 in 2021. As well Compound Annual Growth Rate (CAGR) has in 11.0%. Stem cell growing awareness, stem cell diseases application, screening via genome, therapeutic application and investment on stem cell research, identification of infrastructure stem cell banking and new stem cell identification has significantly increased day-by-day. An official notification has been published by several Indian government bodies, including the CDSCO (Central Drugs Standard Control Organization), Ministry of Health and Family Welfare, Department of Biotechnology, and Ministry of Science and Technology. In addition, 2019 NDCT has developed rules on Drugs and Cosmetics Act and Rules and National Guidelines (2017) for Stem Cell Research products supports to the applicant guidelines. Parley, stem cell regulatory guidelines have support to the stem cell research development and product commercialization and socio-ethical clearance related to Human Embryonic Stem Cells (HESC) utilization has the major factors for the stem market growth significantly. Hence, the common society people have unawareness on the stem cell research and the regulatory approaches. The present articles has focus on i) the stem cell mechanism with regulatory approach pathways and clinical research; ii) Stem cell derived products are future precision therapy for biopharmaceutical companies but also for the patients, who can now have access to disease specific treatment. In addition, the government enhances newer and modern technology with future medicines. The present article completely described the stem cell derived products

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