A key change in rules notified on [March 30] will allow genome-edited plants, or organisms without any “foreign” genes to be subjected to a different regulatory process than the one applied to genetically engineered products — a move likely to add to a polarising debate around technologies such as CRISPR.
One scientist working with GM technologies said the changes will exempt two categories of genome-edited products — in which genes are tweaked but not inserted from another organism — from being treated as transgenic products.
There are three categories of gene-editing: SDN1, SDN2 and SDN3. The first two, which largely involve “knocking off” or “overexpressing” certain traits in a genome without any insertion of gene material from outside, will be covered by the new changes. The third, which involves insertion of foreign genes, will be treated as GMO. SDN stands for Site-directed Nuclease and refers to the practice of cleaving DNA strands to effect the subsequent genome editing.
“With this, India now has a separate regulatory process for such technologies that takes them out of the purview of Genetic Engineering Appraisal Committee or GEAC,” said Bhagirath Choudhary of the South Asia Biotechnology Centre, which advocates GM technologies.