Regulation of CRISPR-Mediated Genome Editing in Humans: An Indian Perspective
DOI:
https://doi.org/10.47353/lawpass.v3i2.117Keywords:
CRISPR, germline, genome editing, heritable, gene therapy, regulationAbstract
November 2025 marked seven years since a Chinese biophysicist declared having used the controversial CRISPR technology to produce the world’s first genome-edited baby. Much before this unprecedented application of CRISPR, the scientific community has been rallying for an international moratorium on heritable genome editing in humans. Although global consensus makes room for uninheritable gene therapies, but the regulatory approvals for CRISPR-mediated gene therapies have only just begun to be considered. What lies ahead is an uphill battle for responsible and uniform policymaking, as well as public acceptance of novel gene-editing techniques in the backdrop of localized social, political, and religious affiliations. This paper aims to analyze several legal frameworks governing the use of CRISPR technology in humans, with a particular focus on Indian biotechnology regulations. It further identifies crucial shortcomings in the existing biomedical policies and carves a pathway for better regulation and widespread acceptance towards this groundbreaking technology.
References
Baghel S, (in answer to the Lok Sabha Unstarred Question No. 304), ‘Tackling Sickle Cell Anemia Using Crisp Cas-9 Therapy’ (The Ministry of Health and Family Welfare of Government of India, 21 July 2023) https://sansad.in/getFile/loksabhaquestions/annex/1712/AU304.pdf?source=pqals accessed 24 January 2024
Bailey E, ‘How CRISPR Gene Editing May Help Reverse Vision Loss’, Healthline (17 March 2023) https://www.healthline.com/health-news/how-crispr-gene-editing-may-help-reverse-vision-loss#:~:text=The%20scientists%20used%20the%20CRISPR,normal%20electrical%20responses%20to%20light accessed 5 December 2023
Baylis F and others, ‘Human Germline and Heritable Genome Editing: The Global Policy Landscape’ (2020) 3 The CRISPR Journal 365
Blog Morulaa, ‘SEC - Special Expert Committee, India Update’ (Morulaa HealthTech Pvt. Ltd., 17 April 2024) https://morulaa.com/blog-morulaa/sec-special-expert-committee/ accessed 23 January 2024
Central Drugs Standard Control Organization, ‘About CDSCO’ (CDSCO) https://cdsco.gov.in/opencms/opencms/en/Home/#:~:text=The%20Central%20Drugs%20Standard%20Control,Authority%20(NRA)%20of%20India accessed 18 January 2024
Chattoo S and others, ‘A social profile of deaths related to sickle cell disease in India: a case for an ethical policy response’ (2023) 11 Frontiers in public health
Cheng Y, Wang H, and Li M, ‘The promise of CRISPR/Cas9 technology in diabetes mellitus therapy: How gene editing is revolutionizing diabetes research and treatment’ (2023) 37(8) Journal of diabetes and its complications 108524
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (concluded 4 April 1997, entered into force 1 December 1999) CETS 164 (Oviedo Convention)
Cornetta K and others, ‘Gene therapy access: Global challenges, opportunities, and views from Brazil, South Africa, and India’ (2022) 30(6) Molecular Therapy 2122
The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO), International Ethical Guidelines for Health-related Research Involving Humans (4th edn, Council for International Organizations of Medical Sciences (CIOMS) 2016)
Delaney J, ‘The Catholic Position on Germ Line Genetic Engineering’ (2009) 9 The American Journal of Bioethics 33
Department of Biotechnology (under the aegis of Ministry of Science and Technology, Government of India), ‘National Biotechnology Development Strategy [2021-2025]’ (DBT 2021)
Drug Controller General (India), ‘Panels of experts for Subject Expert Committees’ (Order in F.No.12-01/14-DC(Pt.20)) (CDSCO, 5 January 2015) https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadPublic_NoticesFiles/SubjectExpertCommittee_205.pdf accessed 23 January 2024
FitzGerald K, ‘Human Genome Editing, A Catholic Perspective’ (2017) 17(1) The National Catholic Bioethics Quarterly 107
Garg N, ‘Understanding the Regulatory Regime for Clinical Trials in India,’ LiveLaw (21 August 2020) https://www.livelaw.in/columns/understanding-the-regulatory-regime-for-clinical-trials-in-india-161763 accessed 23 December 2023
Garneau J and others, ‘The CRISPR/Cas bacterial immune system cleaves bacteriophage and plasmid DNA’ (2010) 468 Nature 67
Gene Therapy Advisory Committee (GTAC), ‘Seventeenth Annual Report’ (2010) https://assets.publishing.service.gov.uk/media/5a7b848b40f0b645ba3c4d69/dh_132738.pdf accessed 12 January 2024
Ghorbani A and others, ‘A short overview of CRISPR-Cas technology and its application in viral disease control’ (2021) 30(3) Transgenic Research 221
Goodyear D, ‘Dangerous Designs: Gene editing gives us transformative powers. But should we use them?’ The New Yorker times (2 September 2023) https://www.newyorker.com/magazine/2023/09/11/the-transformative-alarming-power-of-gene-editing accessed 3 December 2023
Goodyear M, Krleza-Jeric K, and Lemmens T, ‘The Declaration of Helsinki’ (2007) 335(7621) BMJ 624 https://doi.org/10.1136/bmj.39339.610000.BE accessed 10 January 2024
Grace K, ‘The Asilomar Conference: A Case Study in Risk Mitigation’ (Machine Intelligence Research Institute, 15 July 2015) https://intelligence.org/files/TheAsilomarConference.pdf accessed 13 January 2024
Greely H, ‘CRISPR’d babies: human germline genome editing in the ‘He Jiankui affair’’ (2019) 6(1) Journal of Law and Biosciences 111, https://doi.org/10.1093/jlb/lsz010 last accessed 2 December 2023
Greenfield A, ‘Fearful old world? A commentary on the Second International Summit on human genome editing’ (2019) 30(1-2) Mammalian Genome: Official Journal of the International Mammalian Genome Society 1
Gunningham N, and Sinclair D, ‘Smart regulation’ in Peter Drahos (ed), Regulatory Theory: Foundations and applications (ANU Press 2017)
Guo C and others, ‘Off-target effects in CRISPR/Cas9 gene editing’ (2023) 11 Frontiers in Bioengineering and Biotechnology https://doi.org/10.3389/fbioe.2023.1143157 accessed 2 December 2023
Hamzelou J, ‘CRISPR for high cholesterol: 10 Breakthrough Technologies 2023’ MIT Technology Review (9 January 2023) https://www.technologyreview.com/2023/01/09/1064857/crispr-high-cholesterol-10-breakthrough-technologies-2023/ accessed 6 December 2023
Hofmann B, ‘‘You are inferior!’ Revisiting the expressivist argument’ (2017) 31(7) Bioethics 505
Human Genome Editing Initiative’ (The National Academies of Sciences, Engineering, and Medicine) https://www.nationalacademies.org/our-work/human-gene-editing-initiative/about accessed 23 January 2024
Iglesias-Lopez C and others, ‘Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States’ (2019) 10 Frontiers in Pharmacology 921https://doi.org/10.3389/fphar.2019.00921 accessed 13 January 2024
Iltis A, Hoover S, and Matthews K, ‘Public and Stakeholder Engagement in Developing Human Heritable Genome Editing Policies: What Does it Mean and What Should it Mean?’ (2021) 3 Frontiers in Political Science https://doi.org/10.3389/fpos.2021.730869 accessed 17 January 2024
Indian Council of Medical Research, ‘About Us’, (ICMR) https://main.icmr.nic.in/content/about-us accessed 17 January 2024
‘International Clinical Trials Registry Platform (ICTRP)’, (World Health Organization) https://www.who.int/clinical-trials-registry-platform accessed 13 January 2024
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Guideline on Good Clinical Practice (GCP) (Integrated Addendum to ICH E6(R1) document approved in 1996 through the adoption of E6(R2) on 9 November 2016)
James T, ‘Zoomed Out| Pharma Patents —why India's IPR regime surrendering to global pressure’ CNBC TV 18 (30 October 2023) https://www.cnbctv18.com/healthcare/access-to-cheaper-medicines-under-threat-changing-pharma-patent-law-why-indias-ipr-regime-surrendering-to-global-pressure-18184011.htm accessed 22 January 2024
Kalpana Mehta v Union of India (2018) 7 SCC 1
Kleiderman E, and Norris Kellner Stedman I, ‘Human germline genome editing is illegal in Canada, but could it be desirable for some members of the rare disease community?’ (2020) 11 Journal of Community Genetics 129
Kolata G, ‘F.D.A. Approves Sickle Cell Treatments, Including One That Uses CRISPR’ The New York Times (8 December 2023) https://www.nytimes.com/2023/12/08/health/fda-sickle-cell-crispr.html accessed 22 January 2024
Kosicki M, Tomberg K, and Bradley A, ‘Repair of CRISPR-Cas9–induced double-stranded breaks leads to large deletions and complex rearrangements’ (2018) 36 Nature Biotechnology 765
Kubikova N and others, ‘Deficiency of DNA double-strand break repair in human preimplantation embryos revealed by CRISPR-Cas9’ (2023) 38(1) Human Reproduction, https://doi.org/10.1093/humrep/dead093.089 accessed 2 December 2023
Kupferschmidt K, ‘Gene-editing summit touts sickle cell success, while questions on embryo editing linger’ Science (13 March, 2023) https://www.science.org/content/article/gene-editing-summit-touts-sickle-cell-success-while-questions-embryo-editing-linger accessed 4 December 2023
Lander E and others, ‘Adopt a Moratorium on Heritable Genome Editing’ (2019) 567 Nature 165
‘Legal framework: Advanced therapies’ (European Medicines Agency) https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/legal-framework-advanced-therapies accessed 12 January 2024
Liu S, ‘Legal reflections on the case of genome-edited babies’ (2020) 5 Global Health Research and Policy 24
Macintosh K, ‘The Regulation of Human Germline Genome Modification in the United States’ in Andrea Boggio, Cesare Romano and Jessica Almqvist (eds) Human Germline Genome Modification and the Right to Science (Cambridge University Press 2019)
Mahalatchimy A, and Rial-Sebbag E, ‘Deciphering the Fragmentation of the Human Genome Editing Regulatory Landscape’ (2022) 3 Frontiers in Political Science https://doi.org/10.3389/fpos.2021.793134 accessed 12 January 2024
Marchant G, ‘Global Governance of Human Genome Editing: What Are the Rules?’ (2021) 22 Annual Review of Genomics and Human Genetics 385
Mathur R, and Swaminathan S, ‘National ethical guidelines for biomedical & health research involving human participants, 2017: A commentary’ (2018) 48(3) Indian Journal of Medical Research 279
Nadimpally S, Mishra G, and Tella K, ‘How subpar treatment options allow sickle cell disease to persist | Explained’ The Hindu (27 March 2024) https://www.thehindu.com/sci-tech/science/sickle-cell-disease-crispr-hydroxyurea-healthcare-amenities/article67994033.ece accessed 22 January 2024
National Academies of Sciences, Engineering, and Medicine, Human Genome Editing: Science, Ethics, and Governance (The National Academies Press 2017)
National Academies of Sciences, Engineering, and Medicine, International Summit on Human Gene Editing: A Global Discussion (The National Academies Press 2015)
National Academies of Sciences, Engineering, and Medicine, Second International Summit on Human Genome Editing: Continuing the Global Discussion: Proceedings of a Workshop–in Brief (The National Academies Press 2019)
National Academies of Sciences, Engineering, and Medicine, Third International Summit on Human Genome Editing: Expanding Capabilities, Participation, and Access: Proceedings of a Workshop—in Brief (The National Academies Press 2023)
National Academy of Medicine, National Academy of Sciences, and the Royal Society, Heritable Human Genome Editing (The National Academies Press 2020)
National Ethical Guidelines for Biomedical and Health Research Involving Human Participants 2017 (India)
National Ethical Guidelines for Biomedical Research Involving Children 2017 (India)
National Guidelines for Gene Therapy Product Development and Clinical Trials 2019 (India) (GTP Guidelines)
National Guidelines for Stem Cell Research 2017 (India)
The New Drugs and Clinical Trials (Third Amendment) Rules 2022 (India) Rule 8 (3) (ii)
The New Drugs and Clinical Trials Rules 2019 (India)
NIH Director, ‘Statement on NIH funding of research using gene-editing technologies in human embryos’ (National Institutes of Health, 28 April 2015) https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos accessed 7 January 2024
Nishith Desai Associates, ‘Clinical Trials and Biomedical Research in India — Legal and Regulatory Framework’ (nishithdesai.com, July 2023) https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Research_Papers/Clinical-Trials-in-India.pdf accessed 19 January 2024
Nordberg A, ‘Genome editing in humans: A survey of law, regulation and governance principles’ Panel for the Future of Science and Technology (STOA), European Parliament (3 June 2022) https://www.europarl.europa.eu/stoa/en/document/EPRS_STU(2022)729506 accessed 10 January 2024
Normile D, ‘In wake of gene-edited baby scandal, China sets new ethics rules for human studies’ Science (7 March 2023) https://www.science.org/content/article/wake-gene-edited-baby-scandal-china-sets-new-ethics-rules-human-studies accessed 9 January 2024
Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R 778(E) dated 14th October 2022 in the Gazette of India
Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) number G.S.R 53(E) dated 30th January 2013 in the Gazette of India
Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) number G.S.R 63(E) dated 1st February 2013 in the Gazette of India
Notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) number G.S.R 72(E) dated 8th February 2013 in the Gazette of India
The Organising Committee of the Third International Summit on Human Genome Editing, ‘Statement from the Organising Committee of the Third International Summit on Human Genome Editing’ (The Royal Society, 8 March 2023) https://royalsociety.org/news/2023/03/statement-third-international-summit-human-genome-editing/ accessed 7 December 2023
Padmanabhan A, Reddy S, and Sharma S, ‘Modern Biotechnology and India’s Governance Imperatives’ (Carnegie Endowment for International Peace, October 2017) http://www.jstor.com/stable/resrep12920 accessed 10 January 2024
The Parliamentary Office of Science and Technology, ‘Human Germline Genome Editing’ (POSTNOTE Number 611) (January 2020) https://researchbriefings.files.parliament.uk/documents/POST-PN-0611/POST-PN-0611.pdf accessed 18 January 2024
Peters T, ‘CRISPR, the Precautionary Principle, and Bioethics’ (2015) 13(3) Theology and Science 267
‘Recombinant DNA Technologies and Researchers’ Responsibilities, 1973-1980’ (National Library of Medicine) https://profiles.nlm.nih.gov/spotlight/cd/feature/dna accessed 12 January 2024
Research and Enterprise Division, ‘Medicines and Healthcare products Regulatory Agency (MHRA) review’ (University of Bristol) https://www.bristol.ac.uk/red/research-governance/ethics/mhra-review/ accessed 12 January 2024
Schaefer G, ‘Why treat gene editing differently in two types of human cells?’ The Conversation (7 December 2015) https://theconversation.com/why-treat-gene-editing-differently-in-two-types-of-human-cells-51843 accessed 8 December 2023
Seitz J, ‘Striking a Balance: Policy Considerations for Human Germline Modification’ (2018) 16 Santa Clara Journal of International Law 60
Singh N and others, ‘New drugs and clinical trials rules 2019: Changes in responsibilities of the ethics committee’ (2020) 11(1) Perspectives in Clinical Research 37
Stefanoudakis D and others, ‘The Potential Revolution of Cancer Treatment with CRISPR Technology’ (2023) 15(6) Cancers 1813
Stein R, ‘Chinese Scientist Says He's First To Create Genetically Modified Babies Using CRISPR’ NPR (26 November 2018) https://www.npr.org/sections/health-shots/2018/11/26/670752865/chinese-scientist-says-hes-first-to-genetically-edit-babies accessed 28 November 2023
Sufian S, and Garland-Thomson R, ‘The Dark Side of CRISPR’ Scientific American (16 February 2021) https://www.scientificamerican.com/article/the-dark-side-of-crispr/ accessed 7 December 2023
Swasthya Adhikar Manch, Indore v Ministry of Health and Family Welfare (2014) 14 SCC 788
——, ‘Nationalism has no place in drug regulation’ (Dinesh Thakur, 29 January 2021) https://dineshthakur.com/2021/01/29/nationalism-has-no-place-in-drug-regulation/ accessed 23 January 2024
Thakur D, ‘How legit are Emergency Use Authorizations in India?’ (Dinesh Thakur, 26 July 2020) https://dineshthakur.com/2020/07/26/how-legit-are-emergency-use-authorizations-in-india/ accessed 23 January 2024
Universal Declaration on Bioethics and Human Rights, (19 October 2005) UNGC 33 C/Res 36
Universal Declaration on the Human Genome and Human Rights (11 November 1997) UNGC 29 C/Res 16 (UDHGHR)
Venugopal B and others, ‘Overview of the National Ethics Committee Registry for Biomedical and Health Research in India: Stepping up to safeguard the ethical aspect of research involving human participants’ (2023) 55(4) Indian Journal of Pharmacology 251
Walsh F, ‘Casgevy: UK approves gene-editing drug for sickle cell’ BBC (16 November 2023) https://www.bbc.com/news/health-67435266 accessed 4 December 2023
WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, Human genome editing: a framework for governance (World Health Organization 2021)
WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, Report of the Second Meeting (World Health Organization 2019) https://www.who.int/publications/i/item/WHO-SCI-RFH-2019-02 accessed 15 January 2024
Wu K, Zimmer C, and Peltier E, ‘Nobel Prize in Chemistry Awarded to 2 Scientists for Work on Genome Editing’ The New York Times (7 October, 2020) https://www.nytimes.com/2020/10/07/science/nobel-prize-chemistry-crispr.html accessed 23 November 2023
Yotova R, ‘Regulating Genome Editing Under International Human Rights Law’ (2020) 69(3) International & Comparative Law Quarterly 653, 669
Zamecnik A, ‘CRISPR gene therapies: Is 2023 a milestone year in the making?’ Pharmaceutical Technology (3 January 2023) https://www.pharmaceutical-technology.com/features/crispr-gene-therapies-is-2023-a-milestone-year-in-the-making/ accessed 5 December 2023
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