Government releases National Guidelines for Stem Cell Research

 

Basic guidelines for stem cell research were released in 2007 by joint efforts of DBT & ICMR which are revised in December 2013 after evaluating development in field of stem cell research. These newer guidelines are termed as 'National Guidelines for Stem Cell Research'.

These guidelines foresee positioning National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and Institutional Committee for Stem Cell Research (IC-SCR) to monitor and oversee activities at national level and institutional level, respectively. NAC-SCRT and IC-SCR will make certain that review, approval and monitoring of the research projects in the field of stem cell research are performed effectively as per the national guidelines.

These guidelines are applied to all stakeholders which include researchers, organizations, sponsors, regulatory committees and any others associated with both basic and clinical research on all types of human stem cells and their derivatives. Guidelines clearly indicates that any stem cell use in patients other than hematopoietic stem cell is under investigation at present.

In National Guidelines for Stem Cell Research exclude therapy from the title of the guidelines. This is performed due to realizing facts that stem cells are still not a part of standard of care and in developing state hence there can be no guidelines for therapy until efficacy is proven.

Ministry of Health and Family Welfare has established Stem Cell division within biological division in Central Drugs Standard Control Organization for the internal evaluation of all proposals including Stem Cell concerning with clinical trial and marketing authorization before referring to CBBTDEC (Cellular Biology Based Therapeutic Drug Evaluation Committee). CBBTDEC is headed by chairmanship of Director General, ICMR & Secretary, DHR to advice DCGI in matters pertaining to regulatory pathways leading to the approval of clinical trials and market authorization for the therapeutic products derived from Stem Cell, human gene manipulation and xenotransplantation technology


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