The 'National Guidelines for Stem Cell Research', issued recently by the union health ministry, has prohibited stem cell research in several areas including the research related to human germ line gene therapy and reproductive cloning; and clinical trials involving transfer of xenogeneic cells into a human host.
As per the guidelines, in the current state of scientific and technological understanding, research in stem cells is prohibited in areas related to human germ line gene therapy and reproductive cloning;in vitro culture of intact human embryos, regardless of the method of their derivation, beyond 14 days of fertilisation or formation of primitive streak, whichever is earlier; and clinical trials involving transfer of xenogeneic cells into a human host.
Besides, any clinical research on xenogeneic-human hybrids is also prohibited. Other areas of prohibition include research involving implantation of human embryos (generated by any means) into uterus after in vitro manipulation, at any stage of development, in humans or primates; and breeding of animals in which any type of human stem cells have been introduced at any stage of development, and are likely to contribute to gonadal cells.
Apart from this, the Guidelines have restricted research in several areas including creation of a human zygote by IVF, SCNT or any other method with the specific aim of deriving ES cell line for any purpose. This shall require several parameters such as that the proposed research cannot be carried out with existing ES cell lines, or those that can be derived from spare embryos; minimum numbers of embryos/blastocysts required for this research are clearly defined; and research teams involved have appropriate expertise and training in derivation, characterisation and culture of ESCs.
Clinical trials using cells derived from the differentiation of human ES or iPS cells, or any stem cell after major manipulation shall require approval of DCGI after obtaining approval from NAC-SCRT through IC-SCR and IEC. Clinical trials sponsored by multinationals, employing cell products developed outside India, will also need prior approval from DCGI through IC-SCR and IEC.
Besides, international collaborative research projects should get clearance from the respective funding agencies as per their established procedure e.g. Health Ministry’s Screening Committee (HMSC). The imports of biological materials for research and development is regulated by Government of India vide their notification (No. L./950/53/97-H1 (Pt.) dated 19th Nov 1997.
Import of ‘drugs’ (therapeutic products – including cells) requires license from the DCGI as per the regulations. Research involving introduction of human ES / iPS / SS cells into animals (including primates), at embryonic or foetal stages of development for studies on pattern of differentiation and integration of human cells into non-human animal tissues shall conform to the conditions that if there is a possibility that human stem cells could contribute in a major way to the development of brain or gonads of the recipient animal, the scientific justification for the experiments must be substantiated. Animals derived from these experiments shall not be allowed to breed; and such proposals would need approval of the NAC-SCRT for additional oversight and review through IAEC and IC-SCR.
Studies on chimeras where stem cells from two or more species are mixed at any stage of development viz., embryonic, foetal or postnatal, for studies on pattern of development and differentiation would require prior approval of NAC-SCRT through IC-SCR and IAEC. Research in which the identity of the donors of blastocysts, gametes, or somatic cells from which the human ES/iPS cells were derived is readily ascertainable or could become known to the investigator would also require prior approval of NAC-SCRT through IC-SCR and IEC.
The union health ministry had issued the 'National guidelines for stem cell research' which will provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country. These guidelines were jointly prepared by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).