The Indian Council of Medical Research (ICMR) in association with the Department of Biotechnology (DBT) has issued the revised draft National Guidelines for Stem Cell Research, 2017 which were prepared after incorporating recent advances in the stem cell sector.

These guidelines are applicable to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and all others associated with both basic and clinical research involving any kind of human stem cells and their derivatives. The guidelines do not apply to research using non-human stem cells or tissues. Further, these do not apply to use of hematopoietic stem cells for treatment of various haematological, immunological and metabolic disorders since these have already been established as a standard of medical care.

The guidelines reiterate that the general principles of biomedical research involving human participants shall also be applicable to all human stem cell research. The guidelines specify unique provisions of stem cells, because of their inherent potential for unlimited proliferation, differentiation to cells of the germ layers, regeneration of tissues, oncogenic potential, unrecognised toxicities and possible involvement in pre implantation stages of human development.

The guideline focuses on monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation; procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution; and other important areas like international collaboration, exchange of cell/ lines and education for stakeholders and advertisement.

The guidelines have been laid down to ensure that all research with human stem cells is conducted in an ethical and scientifically responsible manner. All researchers and stakeholders are required to comply with all regulatory requirements pertaining to biomedical research in general and stem cell research in particular.

Earlier in 2007, the ICMR and DBT had first framed the Guidelines for Stem Cell Research and Therapy. The National Apex Committee for Stem Cell Research (NAC-SCRT) and drafting committee decided to update these guidelines from time to time based on new knowledge generated in the field. Hence these were further revised in 2013 as National Guidelines for Stem Cell Research (NGSCR). This document has been revised incorporating recent advances.

The ICMR has now invited comments and suggestions from all the stakeholders before July 31, 2017.