Title:Regulation of Genome-edited Technologies: Indian Policy Perspective
Volume: 1
Author(s): Amita Prasad and Murali Krishna Chimata*
Affiliation:
- Additional Director, Ministry of Environment, Forest & Climate Change, Karnataka, India
Keywords:
Regulation, Genome, Editing policy, SDN1, SDN2, Technological advances.
Abstract: The rapid technological advances in the field of biotechnology have resulted in the formulation of effective and robust regulatory policy
frameworks by different countries to ensure the safety of the products that are being developed through the application of genome editing
techniques both in terms of environment and health safety perspectives. With over two and half decades of use of products derived from the
application of genetic engineering technologies, this technology has stemmed the emergence of an even more advanced and precise targeted
technology to address the most complicated and intrinsic challenges in a more precise manner which is now considered as Genome Editing. It is
astounding to note that, at a time when several nations were debating and discussing the regulatory hurdles regarding the regulation of this
technology, India has emerged as one nation with a clear policy framework with well-defined definitions in Rules 1989 itself, wherein, the
definition of Gene Technology and Genetic Engineering clearly states that any alteration in the genome needs to be regulated and accordingly,
India needs to regulate the products that would be developed through this novel genome editing technology. However, recognizing the global
developments and after a thorough assessment of safety aspects, India, in the year 2022 promulgated the “ Guidelines for the Safety Assessment of
Genome Edited Plants” wherein, it is explicitly detailed that products that are derived from SDN-1 and SDN-2 techniques and which are free of
exogenous introduced DNA, are exempted from the provisions of Rules 7 to 11 (both inclusive) of the above said Rules 1989 and products derived
from SDN-3 would be regulated as per provisions of Rules, 1989. If required, the concerned regulatory agencies may stipulate additional safety
evaluation tests through better risk evaluation methodologies and a greater number of laboratories could also be set up along with empowering the
human resource capacities for undertaking such state-of-the-art and precise techniques for the development of safe and beneficial products for the
public without compromising on the safety.
