Notification of Standard Operating Procedures for regulatory review of Genome Edited Plants under SDN-1 and SDN-2 categories 2022

Modern biotechnology has been advancing at a rapid pace with the advent of new molecular techniques and their potential applications. Plant genome editing is amongst one of the most promising technologies in terms of applied biological research and innovation with a huge economic potential in a wide range of sectors. Department of Biotechnology, Ministry of Science and Technology proactively initiated the development of draft Guidelines for the safety assessment of Genome Edited Plants through extensive deliberations.

Ministry of Environment, Forest and Climate Change issued an Office Memorandum on 30th March 2022 for exemption of SDN-1 and SDN-2 categories of Genome Edited Plants which are free of exogenous introduced DNA from the provisions of Rules 7 to 11 (both inclusive) of the Rules 1989 of EPA, 1986. The draft guidelines were accordingly revised, considered and approved by Review Committee on Genetic Manipulation (RCGM) in its 231st meeting held on 28.04.2022. Thereupon, the “Guidelines for the Safety Assessment of Genome Edited Plants, 2022 were notified on 17th May 2022. The guidelines determine regulatory requirement for appropriate category of experiments and provide the regulatory framework and scientific guidance on data requirement in context of research & development of Genome Edited Plants. 

Towards enabling biosafety regulation by Institutional Biosafety Committees (IBSCs) the SOPs and Checklist were drafted to bring clarity to all the stakeholders. Based on RCGM recommendations the “Standard Operating Procedures (SOPs) for regulatory review of Genome Edited Plants under SDN-1 and SDN-2 categories, 2022”, were notified on 04th Oct 2022. These SOPs shall be applicable for all organizations involved in research, development and handling of the Genome Edited Plants under SDN-1 and SDN-2 categories from the date of notification. The SOPs provide regulatory road map, requirements for research and development and meet the threshold for exemption of Genome Edited Plant(s) under the SDN-1 or SDN-2 categories. 

Considering huge growth and advancement in genome editing research and applications in the field of agriculture, these Guidelines & SOPs will be very valuable resource documents for the country. These Guidelines & SOPs are expected to speed up development of plant varieties and to reduce the time of approval. New plant varieties with improved traits would contribute towards increasing Farmer's income. Overall, this regulatory streamlining will bring transformational change in product development and commercialization and thereby will contribute to agenda for Atma Nirbhar Bharat of Government of India. This has also paved the way for India as emerging global power in Genome Edited Plants based technology and its applications.

Source : PIB