The salient features of the National Guidelines for Stem Cell Research (2013) are as follows:
• National Guidelines for Stem Cell Therapy – 2013 reiterate that the general principles of biomedical research involving human participants shall also be applicable to all human stem cell research.
• The guidelines have been laid down to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular.
• Updated guidelines have incorporated advances in the field with regards to induced pluripotent stem cells (iPSCs), xeno-free cultures, characterising cell product for therapy and to harmonize them with the internationally revised guidelines.
• One major recommendation of the Committee has been to omit the word Therapy from the title of the Guidelines. This has been done to emphasize the fact that stem cells are still not a part of standard of care; hence there can be no guidelines for therapy until efficacy is proven.
• These guidelines are intended to cover only stem cell research, both basic and translational, and not therapy. It has been made clear in these Guidelines that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present.
Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy.
In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial shall be considered as malpractice. It is hoped that this clear definition will serve to curb the malpractice of stem cell “therapy” being offered as a new tool for treating incurable diseases.
• These Guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any others associated with both basic and clinical research on all types of human stem cells and their derivatives.
National Guidelines for Stem Cell Research envisage setting up of a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) to monitor and oversee activities at national level and Institutional Committee for Stem Cell Research (IC-SCR) at institutional level. These Committees shall ensure that review, approval and monitoring of the research projects in the field of Stem Cell Research are done rigorously and effectively as per the national guidelines. Few cases of violations have been received by NAC-SCRT. After deliberations, these cases have been forwarded to concerned regulatory authorities/agencies for necessary action.
Ministry of Health and Family Welfare vide order dated 01-09/2010 constituted a Core Investigational New Drug Panel of Experts namely “Cellular Biology Based Therapeutic Drug Evaluation Committee (CBBTDEC) under the 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”.
CBBTDEC has deliberated on the need for strengthening the regulatory agency (DCGI) by establishing separate wing for Stem Cell Research supported with knowledge and capacity to regulate the activities in the country.
Accordingly, Directorate General of Health Services, office of Drugs Controller of General (India) Ministry of Health and Family Welfare, Govt. of India vide order dated 16.03.2012 has established Stem Cell Division within Biological Division in Central Drugs Standard Control Organization (HQ) for the internal evaluation of all proposals including Stem Cell concerning with clinical trial and marketing authorization before referring to CBBTDEC.
This was stated by Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha today.
