• sruti ravindranathan

Human genome engineering and gene editing technologies like CRISPR technology has completely revolutionized human therapeutics, agriculture and the health care industry. With the help of CRISPR technology it is now possible to genetically modify human embryo which in turn has opened the doors to a whole new concept called ‘Designer Babies’ where the parents can choose or alter certain traits of their unborn child. With the use of an advanced technology like CRISPR; a Parent can now, practically design their baby according to their whims and fancies. However, the process of genetically modifying babies involves altering genes in embryos, eggs or sperm. This type of genetic engineering is potentially heritable, meaning that mutated genes may be passed on to the subsequent generations as well and therefore, by editing the genes of one baby, they are potentially mutating the genes and characteristics of generations of humans. This brings to the focus the capability or in some cases, incapability of national and international law to regulate research into this unknown but welcome field. It definitely brings to light certain social, ethical and religious concerns surrounding genetic editing which could be passed from one generation to the other. In this article we aim to analyze the legal and regulatory policy that governs the human gene editing, with specific emphasis on its applicability in the production of designer or genetically modified human babies and analyze the legal position of human gene editing in India. At present The Indian Council of Medical Research or ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research in India. The ICMR has published the National Ethical Guidelines for Biomedical and Health Research on Human Participants, which acts the Guideline for all biomedical research conducted on human participants. The ICMR’s Ethical guideline has explicitly prohibited any form of alteration to Human genes. IThe ICMR has also published the National Guidelines for Stem Cell Research, 2017 which is a set of guidelines that regulate gene editing, human germ line editing, cellular research and cloning in India. According to the guidelines prohibited areas of research includes “Research related to human germ line gene therapy and reproductive cloning” and Use of genome modified human embryos, germ-line stem cells or gametes for developmental propagation. The guidelines set forth by the ICMR prohibit any research or developments in the field of human gene editing but since these are guidelines and not legislation; they lack the force of law and the binding nature of the guidelines are in question. In this article we also dive into the practical enforceability of these guidelines. Through this research paper, the researcher tries to encourage the CRISPR –CAS9 technology by providing adequate suggestions, as complete prohibition and restriction will only hinder and slow down the new innovations in the field.

Key words – CRISPR CAS-9, guidelines, genetic engineering, patent

"Designer babies; An Analysis of legal framework and ethical issues surrounding human gene editing technology ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 6, page no.405-408, June 2019, Available :http://www.jetir.org/papers/JETIR1908861.pdf

"Designer babies; An Analysis of legal framework and ethical issues surrounding human gene editing technology ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 6, page no. pp405-408, June 2019, Available at : http://www.jetir.org/papers/JETIR1908861.pdf