India eases gene editing regulations

The Indian Ministry of Environment, Forest and Climate Change has decided to exempt products derived through two gene editing techniques, site directed nuclease (SDN)-1 and SDN-2, from the purview of the country's regulations governing genetically modified organisms, national media report. The move allows such products to circumvent biosafety assessments undertaken by the country's apex biotechnology regulatory body, the Genetic Engineering Appraisal Committee (GEAC), besides reassigning the jurisdiction of these products to India's Seeds Act, in lieu of the Environment Protection Act.

SDN creates site-specific double-stranded breaks at defined sequences, typically by recognising a specific DNA sequence and cleaving DNA within such a sequence or nearby. SDN-1 produces a double-stranded break in the genome of a plant without the addition of foreign DNA. SDN-2 produces a double-stranded break, and while the break is repaired by the cell, a small nucleotide template is supplied that is complementary to the area of the break, which in turn, is used by the cell to repair the break. SDN-3 also induces a double-stranded break in the DNA but is accompanied by a template containing a gene or other sequence of genetic material. While SDN-1 and SDN-2 result either in a random (SDN-1) or intended (SDN-2) modification of a targeted genomic locus without the insertion of foreign DNA, the aim of the SDN-3 approach is to modify the targeted locus by inserting an exogenous DNA template of various lengths.

Following the new rule development in India, requests for approval of SDN1 and SDN2 gene-edited products are to be treated differently from their transgenic counterparts, as both techniques involve "knocking off" or "overexpressing" certain traits within a gene without introducing new genetic material. However, products derived through SDN-3 will still be considered as GMOs as the process involves the introduction of foreign genes.

India is reportedly leveraging SDN-1 and SDN-2 gene editing to breed new crop varieties and develop traits such as disease resistance and drought tolerance. The government's directive paves the way for plants derived using these processes to be treated at par with their conventionally bred counterparts. Furthermore, it is likely to result in wider adoption of new breeding techniques (NBTs) and gene editing technologies such as CRISPR in plant biotechnology and research.

Notably, India does not allow the commercial cultivation of GM crops for food use. Bt cotton is the only GM crop allowed for cultivation in the country, with the government clearing Bayer legacy business Monsanto's Bollgard I cotton for cultivation in 2005. The GM cotton line contains the Bt Cry1Ac toxin to combat bollworms (Helicoverpa armigera).

Posted 28 April 2022 by Sanjiv Rana, Editor-in-Chief (Crop Science Market Reporting), S&P Global Commodity Insights

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