Abstract
In India, genetically modified organisms and products thereof are regulated under the “Rules for the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc. The definition of genetic engineering in the Rules, 1989 implies that new genome engineering technologies including gene editing technologies like CRISPR/Cas9 and gene drives may be covered under the rules. The regulatory authorities if required, may also review the experiences of other countries in dealing with such new and emerging technologies.
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References
Barfoot P, Brookes G (2014) Key global environmental impacts of genetically modified (GM) crop use 1996–2012. GM Crops Food 5:149–160. https://doi.org/10.4161/gmcr.28449
Barrows G, Sexton S, Zilberman D (2014) The impact of agricultural biotechnology on supply and land-use. Environ Dev Econ 19:676–703. https://doi.org/10.1017/s1355770x14000400
Bawa A, Anilakumar K (2013) Genetically modified foods: safety, risks and public concerns—a review. J Food Sci Technol 50(6):1035–1046. https://doi.org/10.1007/s13197-012-0899-1
Bhuvan BJ, Ashutosh S (2017) Evaluating the law on regulation of genetically modified crops in India. Jamia Law J 2:119–137
Brookes G, Barfoot P (2016) Global income and production impacts of using GM crop technology. 1996–2014. GM Crops Food 7:38–77
Carpenter JE (2013) The socio-economic impacts of currently commercialised genetically engineered crops. Int J Biotechnol 12:249–268. https://doi.org/10.1504/ijbt.2013.059248
Chatterjee A, Pohit S, Ghose A (2016) Trade and distributional impacts of genetically modified crops in India: a CGE analysis. Margin: J Appl Econ Res 10(3):381–407. https://doi.org/10.1177/0973801016645414
Choudhary B, Gaur K (2015) Biotech Cotton in India, 2002 to 2014. ISAAA Series of Biotech Crop Profiles. ISAAA, Ithaca, NY
Choudhary B, Gheysen G, Buysse J, van der Meer P, Burssens S (2014) Regulatory options for genetically modified crops in India. Plant Biotechnol J 12:135–146. https://doi.org/10.1111/pbi.12155
Epifanio L (2017) Towards a new regulatory framework for GM crops in the European Union: scientific, ethical, social and legal issues and the challenges ahead. Wageningen Academic Publishers, Wageningen
Frewer LJ, van der Lans IA, Fischer ARH, Reinders MJ, Menozzi D, Zhang X, van den Berg I, Zimmermann KL (2013) Public perceptions of agri-food applications of genetic modification—A systematic review and meta-analysis. Trends Food Sci Technol 30:142–152. https://doi.org/10.1016/j.tifs.2013.01.003
Herring RJ (2014) On risk and regulation: Bt crops in India. GM Crops & Food 5(3):204–209. https://doi.org/10.4161/21645698.2014.950543
Jaffe G (2004) Regulating transgenic crops: a comparative analysis of different regulatory processes. Transgenic Res 13(1):5–19
James C (2014) Global status of commercialized biotech/GM crops: 2014. ISAAA Brief No. 49. ISAAA, Ithaca, NY
James C (2015) 20th Anniversary (1996 to 2015) of the Global Commercialization of Biotech Crops and Biotech Crop Highlights in 2015
Kandasamy M, Padmavati M (2014) Transgenic crop research and regulation in India: whether legislation rightly drives the motion? J Commer Biotechnol 20(4):17–30
Klümper W, Qaim M (2014) A meta-analysis of the impacts of genetically modified crops. PLoS One 9:e111629. https://doi.org/10.1371/journal.pone.0111629
Krishna V, Qaim M, Zilberman D (2015) Transgenic crops, production risk and agrobiodiversity. Eur Rev Agric Econ. https://doi.org/10.1093/erae/jbv012
Kumar S (2015) India eases stance on GM crop trials. Nature 521:138–139. https://doi.org/10.1038/521138a
McHughen A, Smyth S (2008) US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars. Plant Biotechnol J 6(1):2–12
Nagamangala KC, Sargent DJ, Velasco R, Maffei ME, Malnoy M (2015) Looking forward to genetically edited fruit crops. Trends Biotechnol 33:62–64. https://doi.org/10.1016/j.tibtech.2014.07.003
Nicolia A, Manzo A, Veronesi F, Rosellini D (2013) An overview of the last 10 years of genetically engineered crop safety research. Crit Rev Biotechnol 34:77–88. https://doi.org/10.3109/07388551.2013.823595
Pardey PG, Chan-Kang C, Dehmer SP, Beddow JM (2016) Agricultural R&D is on the move. Nature 537:301–303
Raman R (2017) The impact of Genetically Modified (GM) crops in modern agriculture: a review. GM Crops Food 8(4):195–208. https://doi.org/10.1080/21645698.2017.1413522
Ricroch AE, Hénard-Damave M-C (2015) Next biotech plants: new traits, crops, developers and technologies for addressing global challenges. Crit Rev Biotechnol. https://doi.org/10.3109/07388551.2015.1004521
Schnell J, Steele M, Bean J, Neuspiel M, Girard C, Dormann N, Pearson C, Savoie A, Bourbonnière L, Macdonald P (2014) A comparative analysis of insertional effects in genetically engineered plants: considerations for pre-market assessments. Transgenic Res 24(1):1–17. https://doi.org/10.1007/s11248-014-9843-7
Sheelendra BM (2015) GMO’s foods: regulatory mechanism and challenges in India. J Bioremed Biodeg 6:e165. https://doi.org/10.4172/2155-6199.1000e165
Sinebo W, Maredia K (2016) Innovative farmers and regulatory gatekeepers: genetically modified crops regulation and adoption in developing countries. GM Crops Food 7(1):1–11. https://doi.org/10.1080/21645698.2016.1151989
Van Eenennaam AL, Young AE (2014) Prevalence and impacts of genetically engineered feedstuffs on livestock populations. J Anim Sci 92:4255–4278. https://doi.org/10.2527/jas.2014-8124
Warrier R, Pande H (2016) Genetically engineered plants in the product development pipeline in India. GM Crops Food 7(1):12–19. https://doi.org/10.1080/21645698.2016.1156826
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Chimata, M.K., Bharti, G. Regulation of genome edited technologies in India. Transgenic Res 28 (Suppl 2), 175–181 (2019). https://doi.org/10.1007/s11248-019-00148-z
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DOI: https://doi.org/10.1007/s11248-019-00148-z