CRISPR Technology — Tech Evolutions

Entry	Year	Description	Impact
ICMR National Ethical Guidelines Update	2017 (with 2024 updates)	The Indian Council of Medical Research (ICMR) updated its 'National Ethical Guidelines for Biomedical and Health Research Involving Human Participants'. These guidelines explicitly address genetic research, permitting somatic cell gene therapy under strict oversight for therapeutic purposes, but unequivocally prohibiting germline gene therapy.	Established a clear ethical and regulatory framework for human gene editing research in India, aligning with international consensus on germline editing. This provides a crucial legal and ethical boundary for CRISPR applications involving human subjects.
DBT Guidelines for Research in Transgenic Plants and GM Crops	2008 (with subsequent clarifications/updates)	The Department of Biotechnology (DBT) issued 'Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Edible GM Crops'. While not specifically for CRISPR, these guidelines form the basis for regulating gene-edited crops in India, with ongoing discussions about whether gene-edited products without foreign DNA should be regulated differently from traditional GMOs.	Provides the foundational regulatory framework for agricultural applications of genetic engineering, including gene-edited crops. The ongoing debate on their classification (as GMOs or distinct entities) significantly impacts their approval and commercialization pathway in India, influencing food security and agricultural innovation.
MoEFCC Notification on Gene-Edited Plants	2022	The Ministry of Environment, Forest and Climate Change (MoEFCC) issued a notification exempting certain gene-edited plants (specifically SDN-1 and SDN-2 categories, which do not involve foreign DNA) from the stringent biosafety regulations applicable to traditional Genetically Modified Organisms (GMOs) under the Environment Protection Act, 1986.	This landmark decision aims to streamline the regulatory process for specific categories of gene-edited crops in India, potentially accelerating their development and commercialization. It acknowledges the precision of CRISPR and differentiates certain gene-edited products from traditional GMOs, fostering innovation in agricultural biotechnology while maintaining biosafety oversight.