SOPs for Regulatory Review
of Genome Edited Plants under SDN-1 and SDN-2 Categories, 2022 Notified
·
Way Cleared for Indian GM Mustard
·
Regulatory Streamlining for
Development of Genome Edited Plants: Resilient Crops for Future
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.