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Current Indian Science

Editor-in-Chief

ISSN (Print): 2210-299X
ISSN (Online): 2210-3007

Review Article

Regulation of Genome-edited Technologies: Indian Policy Perspective

Author(s): Amita Prasad and Murali Krishna Chimata*

Volume 1, 2023

Published on: 03 May, 2023

Article ID: e230223213951 Pages: 6

DOI: 10.2174/2210299X01666230223105053

open_access

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.

Keywords: Regulation, Genome, Editing policy, SDN1, SDN2, Technological advances.

[1]
Georges, F.; Ray, H. Genome editing of crops: A renewed opportunity for food security. GM Crops Food, 2017, 8(1), 1-12.
[http://dx.doi.org/10.1080/21645698.2016.1270489] [PMID: 28075688]
[2]
Nicolia, A.; Manzo, A.; Veronesi, F.; Rosellini, D. An overview of the last 10 years of genetically engineered crop safety research. Crit. Rev. Biotechnol., 2014, 34(1), 77-88.
[http://dx.doi.org/10.3109/07388551.2013.823595] [PMID: 24041244]
[3]
Singhal, T. A review of coronavirus disease-2019 (COVID-19). Indian J. Pediatr., 2020, 87(4), 281-286.
[http://dx.doi.org/10.1007/s12098-020-03263-6] [PMID: 32166607]
[4]
Hu, B.; Guo, H.; Zhou, P.; Shi, Z.L. Characteristics of SARS-CoV-2 and COVID-19. Nat. Rev. Microbiol., 2021, 19(3), 141-154.
[http://dx.doi.org/10.1038/s41579-020-00459-7] [PMID: 33024307]
[5]
Choudhary, B.; Gheysen, G.; Buysse, J.; van der Meer, P.; Burssens, S. Regulatory options for genetically modified crops in India. Plant Biotechnol. J., 2014, 12(2), 135-146.
[http://dx.doi.org/10.1111/pbi.12155] [PMID: 24460889]
[6]
Shukla, M.; Al-Busaidi, K.T.; Trivedi, M.; Tiwari, R.K. Status of research, regulations and challenges for genetically modified crops in India. GM Crops Food, 2018, 9(4), 173-188.
[http://dx.doi.org/10.1080/21645698.2018.1529518] [PMID: 30346874]
[7]
Kandasamy, M.; Manchikanti, P. Transgenic crop research and regulation in India: Whether legislation rightly drives the motion? J. Commer. Biotechnol., 2014, 20(4), 17-30.
[http://dx.doi.org/10.5912/jcb674]
[8]
Jaffe, G. Regulating transgenic crops: A comparative analysis of different regulatory processes. Transgenic Res., 2004, 13(1), 5-19.
[http://dx.doi.org/10.1023/B:TRAG.0000017198.80801.fb] [PMID: 15070071]
[9]
Turnbull, C.; Lillemo, M.; Hvoslef-Eide, T.A.K. Global regulation of genetically modified crops amid the gene edited crop boom–a review. Front. Plant Sci., 2021, 12, 630396.
[http://dx.doi.org/10.3389/fpls.2021.630396] [PMID: 33719302]
[10]
Wolt, J.D.; Wang, K.; Yang, B. The regulatory status of genome-edited crops. Plant Biotechnol. J., 2016, 14(2), 510-518.
[http://dx.doi.org/10.1111/pbi.12444] [PMID: 26251102]
[11]
Lassoued, R.; Phillips, P.W.B.; Macall, D.M.; Hesseln, H.; Smyth, S.J. Expert opinions on the regulation of plant genome editing. Plant Biotechnol. J., 2021, 19(6), 1104-1109.
[http://dx.doi.org/10.1111/pbi.13597] [PMID: 33834596]
[12]
Bradshaw, J.E. Plant breeding: Past, present and future. Euphytica, 2017, 213(3), 60.
[http://dx.doi.org/10.1007/s10681-016-1815-y]
[13]
Sheelendra, B.M. GMO’s foods: Regulatory mechanism and challenges in India. J. Bioremediat. Biodegrad., 2015, 6, e165.
[14]
McHughen, A.; Smyth, S. US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars. Plant Biotechnol. J., 2008, 6(1), 2-12.
[PMID: 17956539]
[15]
Kamthan, A.; Chaudhuri, A.; Kamthan, M.; Datta, A. Genetically modified (GM) crops: Milestones and new advances in crop improvement. Theor. Appl. Genet., 2016, 129(9), 1639-1655.
[http://dx.doi.org/10.1007/s00122-016-2747-6] [PMID: 27381849]
[16]
Fiaz, S. CRISPR/Cas9 regulations in plant science. Nanobiotechnol Approa Plant Breed Protec, 2021, 33-45.
[17]
Sinebo, W.; Maredia, K. Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries. GM Crops Food, 2016, 7(1), 1-11.
[http://dx.doi.org/10.1080/21645698.2016.1151989] [PMID: 26954893]
[18]
Frewer, L.J.; van der Lans, I.A.; Fischer, A.R.H.; Reinders, M.J.; Menozzi, D.; Zhang, X.; van den Berg, I.; Zimmermann, K.L. Public perceptions of agri-food applications of genetic modification – A systematic review and meta-analysis. Trends Food Sci. Technol., 2013, 30(2), 142-152.
[http://dx.doi.org/10.1016/j.tifs.2013.01.003]
[19]
Karthik, K.; Aravindh Babu, R.P.; Dhama, K.; Chitra, M.A.; Kalaiselvi, G.; Alagesan Senthilkumar, T.M.; Raj, G.D. Biosafety concerns during the collection, transportation, and processing of COVID-19 samples for diagnosis. Arch. Med. Res., 2020, 51(7), 623-630.
[http://dx.doi.org/10.1016/j.arcmed.2020.08.007] [PMID: 32948378]
[20]
Christian, M.; Cermak, T.; Doyle, E.L.; Schmidt, C.; Zhang, F.; Hummel, A.; Bogdanove, A.J.; Voytas, D.F. Targeting DNA double-strand breaks with TAL effector nucleases. Genetics, 2010, 186(2), 757-761.
[http://dx.doi.org/10.1534/genetics.110.120717] [PMID: 20660643]
[21]
Murugan, K.; Babu, K.; Sundaresan, R.; Rajan, R.; Sashital, D.G. The revolution continues: Newly discovered systems expand the CRISPR-cas toolkit. Mol. Cell, 2017, 68(1), 15-25.
[http://dx.doi.org/10.1016/j.molcel.2017.09.007] [PMID: 28985502]
[22]
Mali, P.; Yang, L.; Esvelt, K.M.; Aach, J.; Guell, M.; DiCarlo, J.E.; Norville, J.E.; Church, G.M. RNA-guided human genome engineering via Cas9. Science, 2013, 339(6121), 823-826.
[http://dx.doi.org/10.1126/science.1232033] [PMID: 23287722]
[23]
Fyodor, D. Genome editing with zinc finger nucleases. Nature Review Genetics, 2010, 11, 636-646.
[24]
Friedrichs, S.; Takasu, Y.; Kearns, P.; Dagallier, B.; Oshima, R.; Schofield, J.; Moreddu, C. Meeting report of the OECD conference on “Genome editing: Applications in agriculture—implications for health, environment and regulation”. Transgenic Res., 2019, 28(3-4), 419-463.
[http://dx.doi.org/10.1007/s11248-019-00154-1] [PMID: 31309374]
[25]
Cermak, T.; Doyle, E.L.; Christian, M.; Wang, L.; Zhang, Y.; Schmidt, C.; Baller, J.A.; Somia, N.V.; Bogdanove, A.J.; Voytas, D.F. Efficient design and assembly of custom TALEN and other TAL effector-based constructs for DNA targeting. Nucleic Acids Res., 2011, 39(12), e82.
[http://dx.doi.org/10.1093/nar/gkr218] [PMID: 21493687]
[26]
Slaymaker, I.M.; Gao, L.; Zetsche, B.; Scott, D.A.; Yan, W.X.; Zhang, F. Rationally engineered Cas9 nucleases with improved specificity. Science, 2016, 351(6268), 84-88.
[http://dx.doi.org/10.1126/science.aad5227] [PMID: 26628643]
[27]
Cong, L.; Ran, F.A.; Cox, D.; Lin, S.; Barretto, R.; Habib, N.; Hsu, P.D.; Wu, X.; Jiang, W.; Marraffini, L.A.; Zhang, F. Multiplex genome engineering using CRISPR/Cas systems. Science, 2013, 339(6121), 819-823.
[http://dx.doi.org/10.1126/science.1231143] [PMID: 23287718]
[28]
Sathishkumar, R.; Kumar, S.R.; Hema, J.; Baskar, V. Advances in Plant Transgenics: Methods and Applications; Springer: Berlin/Heidelberg, Germany, 2019.
[http://dx.doi.org/10.1007/978-981-13-9624-3]
[29]
Jaganathan, D.; Ramasamy, K.; Sellamuthu, G.; Jayabalan, S.; Venkataraman, G. CRISPR for crop improvement: An update review. Front. Plant Sci., 2018, 9, 985.
[http://dx.doi.org/10.3389/fpls.2018.00985] [PMID: 30065734]
[30]
Waltz, E. CRISPR-edited crops free to enter market, skip regulation. Nat. Biotechnol., 2016, 34(6), 582-583.
[http://dx.doi.org/10.1038/nbt0616-582] [PMID: 27281401]
[31]
Wolter, F.; Schindele, P.; Puchta, H. Plant breeding at the speed of light: The power of CRISPR/Cas to generate directed genetic diversity at multiple sites. BMC Plant Biol., 2019, 19(1), 176.
[http://dx.doi.org/10.1186/s12870-019-1775-1] [PMID: 31046670]
[32]
Warrier, R.; Pande, H. Genetically engineered plants in the product development pipeline in India. GM Crops Food, 2016, 7(1), 12-19.
[http://dx.doi.org/10.1080/21645698.2016.1156826] [PMID: 26954729]
[33]
Chatterjee, A.; Pohit, S.; Ghose, A. Trade and distributional impacts of genetically modified crops in India: A CGE analysis. Margin J. Appl. Econ. Res., 2016, 10(3), 381-407.
[http://dx.doi.org/10.1177/0973801016645414]
[34]
Mathew, D. Biosafety and bioregulatory mechanisms for transgenic crops. In: Genetic Engineering of Horticultural Crops; Academic Press, Elsevier Inc: Cambridge, 2018; pp. 273-314.
[http://dx.doi.org/10.1016/B978-0-12-810439-2.00013-1]
[35]
Guidelines for Safety Assessment of Genome Edited Plants. Department of Biotechnology 2022. Available from: www.dbtindia.gov.in

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