1. Introduction

CRISPR gene editing is a biotechnology technique that enables scientists to modify DNA sequences within living organisms. CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. The most widely used system, CRISPR-Cas9, uses a guide RNA to direct the Cas9 enzyme to a selected DNA sequence, where the enzyme cuts the DNA and allows genetic modification.

CRISPR technology has applications in:

Treatment of inherited genetic disorders.

Cancer research and immunotherapy.

Development of genetically modified crops.

Modification of microorganisms.

Development of disease-resistant animals.

Embryonic and reproductive genetic research.

Development of new pharmaceutical products.

However, gene editing raises serious legal concerns involving human dignity, patient safety, informed consent, genetic privacy, environmental protection, biodiversity, intellectual property and intergenerational responsibility.

CRISPR gene editing restrictions refer to legal, regulatory and ethical limitations imposed on the development, testing, use and commercialisation of gene-editing technologies.

The central legal distinction is between:

Somatic gene editing: Modification of non-reproductive cells, generally affecting only the treated individual.

Germline gene editing: Modification of sperm, eggs or embryos in ways that may transmit genetic changes to future generations.

Most regulatory systems treat these two categories differently because germline modifications may have permanent and inheritable consequences.

2. Legal Framework Governing CRISPR Gene Editing

CRISPR regulation is not governed by one universal law. It involves biotechnology legislation, medical-product regulation, environmental law, research ethics, patent law and constitutional principles.

A. Human rights and bioethics

The major principles governing CRISPR research include:

Human dignity and respect for human life.

Autonomy and informed consent.

Non-maleficence and prevention of avoidable harm.

Beneficence and therapeutic benefit.

Equality and non-discrimination.

Protection against genetic exploitation.

Intergenerational justice.

The UNESCO Universal Declaration on the Human Genome and Human Rights, 1997, recognises the importance of protecting human dignity in genetic research.

Article 11 states that practices contrary to human dignity, such as reproductive human cloning, should not be permitted.

Article 12 recognises freedom of research while requiring respect for human dignity and human rights.

These principles are important when evaluating whether CRISPR research should be permitted for therapeutic purposes, enhancement or reproductive applications.

B. Regulation under international law

Important international instruments

Article 13 of the Oviedo Convention permits interventions on the human genome only for preventive, diagnostic or therapeutic purposes, and only where their aim is not to introduce modifications in the genome of descendants.

The Oviedo Convention is binding on its parties, not universally applicable. India is not a party.

3. CRISPR Gene Editing Restrictions in India

India regulates CRISPR technology through environmental legislation, biotechnology regulations, pharmaceutical laws, clinical-trial requirements and research-ethics standards.

There is no single comprehensive CRISPR statute. Instead, different regulatory authorities supervise different applications.

A. Environment (Protection) Act, 1986

The Environment (Protection) Act, 1986 provides the principal statutory foundation for regulating genetically engineered organisms in India.

The Environment (Protection) Act supports the Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro-organisms/Genetically Engineered Organisms or Cells, 1989.

These Rules regulate activities involving genetically engineered organisms, including relevant research, production, use, import, export and environmental release.

Important regulatory bodies include:

The precise approval required depends on the organism, technique, research stage and intended use.

B. DBT Guidelines for Genome-Edited Plants, 2022

India introduced the Guidelines for Safety Assessment of Genome Edited Plants, 2022.

These guidelines establish a framework for evaluating genome-edited plants and distinguish between different categories of site-directed nuclease technology.

SDN-1: Genome modification through repair without an externally supplied repair template.

SDN-2: Genome modification using a short DNA repair template.

SDN-3: Introduction of larger DNA sequences or genetic material.

The guidelines establish differentiated regulatory treatment for these categories.

The distinction is important because not every genome-edited plant is necessarily treated identically to a conventional transgenic GMO.

However, exemption from a particular regulatory requirement does not mean that every activity involving the organism is automatically exempt from all applicable laws.

C. Pharmaceutical and clinical-trial restrictions

CRISPR-based human therapies are also regulated under:

Drugs and Cosmetics Act, 1940.

New Drugs and Clinical Trials Rules, 2019.

Applicable CDSCO requirements.

ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants.

Applicable institutional ethics and biosafety requirements.

A CRISPR-based therapy cannot be introduced into clinical practice merely because it has demonstrated scientific effectiveness in laboratory research.

Depending on the product and procedure, regulatory approval, clinical-trial authorisation, ethics approval, manufacturing controls and safety evaluation may be necessary.

The Indian regulatory framework also requires particular attention to long-term adverse effects, off-target editing and the possibility of unintended genetic changes.

D. Restrictions on human embryo editing

Human embryo editing for reproductive purposes raises particularly serious legal questions.

India's framework includes the following legislation:

Assisted Reproductive Technology (Regulation) Act, 2021.

Surrogacy (Regulation) Act, 2021.

Rules for embryo research under applicable national regulations.

Research ethics requirements.

Provisions concerning human genetic and reproductive research.

The Research Involving Human Embryos Act, 2002 is an Australian statute, not an Indian statute.

India's reproductive and embryo-research framework must therefore be analysed under Indian legislation rather than incorrectly applying Australian restrictions.

Important distinction: Research involving human embryos and transferring genetically edited embryos for reproductive purposes are legally different activities. The legality of any particular experiment depends on its precise purpose, authorisation and applicable restrictions.

E. Indian regulatory developments

The Government of India has expressly recognised CRISPR-based therapies as subject to biosafety and pharmaceutical oversight.

The 1989 Rules, DBT biosafety guidelines, Institutional Biosafety Committees, RCGM and CDSCO have different responsibilities depending on the activity.

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4. Major Legal Restrictions on CRISPR Gene Editing

A. Restriction on germline genetic modification

Germline editing involves modifying genetic material in reproductive cells or embryos in a manner capable of being inherited by future generations.

This creates legal concerns because future individuals cannot consent to modifications made before their birth.

Potential risks include:

Unintended genetic mutations.

Off-target genetic changes.

Unpredictable biological consequences.

Transmission of harmful mutations.

Permanent changes in hereditary characteristics.

Discrimination based on genetic characteristics.

The legal concern is not simply whether CRISPR can modify DNA successfully, but whether society can justify making permanent inherited changes without sufficient evidence of safety.

The WHO's 2021 recommendations emphasise robust governance, transparency, international cooperation and oversight of somatic, germline and heritable genome editing.

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B. Restriction on genetic enhancement

CRISPR may potentially be used to modify characteristics unrelated to treating a disease.

Examples include:

Increasing muscle strength.

Modifying height-related genetic characteristics.

Altering physical appearance.

Enhancing memory.

Modifying intelligence-related traits.

Improving athletic performance.

This creates a distinction between therapeutic intervention and enhancement.

Therapeutic gene editing aims to prevent, diagnose or treat disease. Enhancement attempts to modify characteristics beyond ordinary medical treatment.

Legal restrictions may arise from medical-device or drug regulation, research ethics, anti-discrimination law and restrictions on reproductive genetic modification.

C. Off-target editing restrictions

Off-target editing occurs when CRISPR modifies DNA at unintended locations.

For example, a CRISPR system intended to correct a mutation responsible for a hereditary disease might also modify another gene.

This could produce:

Cancer-related genetic changes.

Abnormal cellular functioning.

Unintended immune responses.

Developmental abnormalities.

Unexpected hereditary consequences.

Regulatory authorities may require molecular characterisation, preclinical safety studies, appropriate controls and monitoring.

D. Restriction on unauthorised clinical trials

Researchers cannot bypass clinical-trial approval merely by describing an intervention as experimental or innovative.

A CRISPR clinical trial may require:

Scientific and preclinical evidence.

Institutional Ethics Committee approval.

Applicable CDSCO authorisation.

Biosafety review.

Informed consent.

Appropriate participant-selection criteria.

Adverse-event reporting.

Long-term safety monitoring.

Unauthorised human experimentation may result in civil, regulatory or criminal consequences, depending on the conduct and applicable legislation.

E. Environmental release restrictions

CRISPR may be used to modify plants, animals and microorganisms.

The environmental release of these organisms may create risks involving:

Cross-pollination.

Gene flow into wild populations.

Biodiversity loss.

Ecological imbalance.

Development of resistant pests.

Unintended changes to ecosystems.

Gene-drive technology presents particular challenges because engineered genetic traits may spread through populations.

The Cartagena Protocol on Biosafety is relevant to the international movement and handling of living modified organisms within its scope.

F. Restrictions on genetic discrimination

Genetic information may reveal inherited disease risks and other biological characteristics.

Improper use of such information may create discrimination in:

Employment.

Insurance.

Education.

Financial services.

Healthcare.

Reproductive decision-making.

In India, constitutional equality, privacy, dignity and applicable data-protection law are relevant to the protection of genetic information.

The Digital Personal Data Protection Act, 2023 may also be relevant where identifiable genetic information is processed as digital personal data, subject to its applicable provisions and commencement.

G. Restriction on commercialisation

Commercial use of CRISPR technology may involve:

Patent rights.

Licensing restrictions.

Biosafety approvals.

Product quality requirements.

Clinical and pharmaceutical regulation.

Environmental authorisation.

Consumer protection obligations.

A patent does not provide permission to conduct an otherwise prohibited clinical experiment or release an unauthorised genetically modified organism.

5. Important Case Laws Relating to CRISPR Gene Editing Restrictions

There are relatively few reported judicial decisions dealing directly with CRISPR technology. Consequently, courts and regulators must also rely on precedents involving genetic engineering, biotechnology patents, reproductive rights, medical experimentation, privacy and environmental protection.

The following cases are particularly important.

Case 1. He Jiankui Gene-Edited Babies Case (2019), China

Direct CRISPR-related criminal case

Court: Shenzhen Nanshan District People's Court, China.

Facts:

Scientist He Jiankui used CRISPR-Cas9 technology to modify the CCR5 gene in human embryos.

The stated objective was to make children resistant to HIV infection.

The edited embryos were implanted into women, resulting in the birth of three children.

Investigations revealed serious violations, including:

Unauthorised reproductive medical procedures.

Fabrication of ethical approval documents.

Failure to establish adequate safety and effectiveness.

Violation of medical research regulations.

Misleading recruitment and consent practices.

Judgment:

On 30 December 2019, the court convicted He Jiankui and two associates of illegal medical practice.

He Jiankui received:

Three years' imprisonment.

A fine of RMB 3 million.

The other two defendants also received prison sentences and fines.

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Legal principles:

Human embryo gene editing cannot be justified merely by scientific innovation.

Reproductive gene editing requires strict legal and ethical oversight.

Falsification of research approvals creates criminal liability.

Medical experimentation without proper qualifications and authorisation can attract criminal punishment.

Scientific advancement does not override human dignity and participant protection.

Relevance to CRISPR restrictions:

This is one of the most important direct criminal precedents demonstrating the legal risks of unauthorised reproductive CRISPR applications.

Case 2. Monsanto Technology LLC v. Nuziveedu Seeds Ltd. (2019)

Citation: (2019) 3 SCC 381.

Court: Supreme Court of India.

Facts:

The dispute concerned Monsanto's patent relating to a nucleotide acid sequence containing the Bt gene and its use in genetically modified cotton technology.

Nuziveedu Seeds challenged Monsanto's patent rights and licensing arrangements.

The litigation involved questions concerning:

Biotechnology patentability.

Plant-related inventions.

Section 3(j) of the Patents Act, 1970.

The relationship between patent law and plant variety protection.

Judgment:

The Supreme Court set aside the Delhi High Court's summary decision and remanded the dispute for a proper trial because substantial factual and technical issues required examination.

The Supreme Court did not finally determine the patentability of every aspect of the disputed biotechnology invention.

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Legal principles:

Biotechnology inventions must satisfy statutory patentability requirements.

Scientific complexity may require detailed technical evidence.

Patent protection is subject to statutory exclusions.

Biotechnology intellectual property rights must be examined alongside relevant plant variety legislation.

Relevance to CRISPR restrictions:

The case is relevant to CRISPR patents involving edited plants, genetic sequences and agricultural biotechnology.

Section 3(j) of the Patents Act excludes plants and animals in whole or any part thereof, other than microorganisms, including seeds, varieties and species, and essentially biological processes for production or propagation of plants and animals.

A CRISPR invention must therefore be assessed according to the actual subject matter claimed, rather than assuming that every gene-editing invention is patentable.

Case 3. Justice K.S. Puttaswamy (Retd.) v. Union of India (2017)

Citation: (2017) 10 SCC 1.

Court: Supreme Court of India.

Facts:

The case concerned whether privacy is a constitutionally protected fundamental right under the Indian Constitution.

The Supreme Court considered individual autonomy, informational privacy, dignity and personal liberty.

Judgment:

The nine-judge Constitution Bench unanimously recognised privacy as a fundamental right under Article 21 and other freedoms guaranteed by Part III.

The Court recognised informational privacy as an important component of individual privacy.

It also established that restrictions on privacy must satisfy legality, legitimate state purpose and proportionality.

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Legal principles:

Genetic information can raise important informational privacy concerns.

Individuals have an interest in controlling personal information.

Biological and genetic data should not be misused.

Medical interventions must respect personal autonomy.

Restrictions on individual rights must satisfy constitutional standards.

Relevance to CRISPR restrictions:

The judgment is relevant when considering:

Genetic testing without consent.

Unauthorised collection of DNA samples.

Disclosure of inherited disease risks.

Genetic discrimination.

Genetic database surveillance.

Disclosure of embryo and reproductive genetic information.

The case does not specifically decide CRISPR regulation, but provides a constitutional foundation for protecting genetic privacy.

Case 4. Vellore Citizens' Welfare Forum v. Union of India (1996)

Citation: (1996) 5 SCC 647.

Court: Supreme Court of India.

Facts:

The case concerned environmental pollution caused by industrial activities in Tamil Nadu, particularly the discharge of untreated effluents by tanneries.

The Court examined environmental protection and the responsibility of industries to prevent ecological damage.

Judgment:

The Supreme Court recognised the precautionary principle and the polluter-pays principle as essential features of Indian environmental law.

Legal principles:

Environmental protection is a legal responsibility.

Preventive action may be necessary even where scientific certainty is incomplete.

Polluters may be required to compensate for environmental damage.

Sustainable development must be considered in industrial activities.

Relevance to CRISPR restrictions:

The precautionary principle is relevant when assessing the environmental release of gene-edited organisms.

For example, before releasing genetically modified insects or plants, authorities should evaluate:

Ecological effects.

Gene transfer.

Biodiversity risks.

Long-term environmental consequences.

Potential harm to non-target species.

The decision provides a strong environmental-law foundation for regulating potentially harmful genome-editing applications.

Case 5. A.P. Pollution Control Board v. Prof. M.V. Nayudu (1999)

Citation: (1999) 2 SCC 718.

Court: Supreme Court of India.

Facts:

The case concerned environmental clearance and the scientific assessment of potentially hazardous industrial activities.

The Court considered the difficulty courts face when determining disputes involving complicated scientific and technical questions.

Judgment:

The Supreme Court discussed the importance of scientific expertise in environmental decision-making and the precautionary principle.

Legal principles:

Scientific uncertainty must be taken seriously.

Environmental decisions require reliable expert assessment.

Courts should consider specialised scientific knowledge.

Preventive safeguards are important when potential harm is serious.

Relevance to CRISPR restrictions:

CRISPR research involves complex scientific questions relating to off-target mutations, genetic instability and ecological risks.

This precedent supports the use of scientific expertise in regulatory assessment and judicial review of decisions concerning gene-editing activities.

Case 6. The Broad Institute, Inc. v. The Regents of the University of California (2025)

Court: United States Court of Appeals for the Federal Circuit.

Date: 12 May 2025.

Facts:

The dispute concerned competing patent claims relating to CRISPR-Cas9 technology for editing DNA in eukaryotic cells.

The parties disputed priority of invention and the legal significance of earlier scientific disclosures and experimental work.

Judgment:

The Federal Circuit affirmed in part, vacated in part and remanded part of the dispute concerning conception.

It also dismissed Broad's cross-appeal as moot.

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Legal principles:

CRISPR technology is subject to ordinary patent-law requirements.

Conception and proof of invention are important in patent disputes.

Scientific disclosure and experimental evidence may determine patent priority.

Patent ownership and patentability are distinct from regulatory permission to use the technology.

Relevance to CRISPR restrictions:

This decision demonstrates that CRISPR applications are subject to complicated intellectual property disputes.

It is important for biotechnology companies, research institutions and pharmaceutical manufacturers seeking to commercialise gene-editing technologies.

6. Comparative International Regulatory Restrictions

Different countries impose different restrictions on CRISPR research and clinical applications.

A. Australia

Australia has a particularly important distinction between laboratory research and reproductive use.

The Gene Technology Act 2000 regulates dealings with GMOs, subject to statutory exclusions and exemptions.

The Prohibition of Human Cloning for Reproduction Act 2002 and Research Involving Human Embryos Act 2002 establish restrictions on human embryo experimentation and reproductive applications.

The Australian NHMRC explains that some human embryo gene-editing research may be legally permissible under licensing arrangements, but using edited embryos for reproduction is prohibited under sections 15 and 20 of the relevant legislation.

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B. United Kingdom

The Human Fertilisation and Embryology Act 1990, as amended, regulates embryo research through the Human Fertilisation and Embryology Authority (HFEA).

Licensed research involving human embryos is subject to statutory restrictions, including the 14-day research limit, subject to the legislation.

Genetically modified embryos cannot simply be transferred for reproductive purposes under the ordinary licensing framework.

C. United States

The Food and Drug Administration (FDA) regulates gene therapies that fall within its jurisdiction.

CRISPR-based somatic therapies may require investigational new drug authorisation and biologics approval.

Federal restrictions also affect the FDA's ability to consider certain applications involving heritable genetic modification.

Research funding restrictions and clinical-product regulation should be distinguished: they do not amount to a universal prohibition on all CRISPR laboratory research.

7. Legal Liability for Violations of CRISPR Restrictions

Unauthorised CRISPR experimentation can create different forms of legal liability.

A. Criminal liability

Criminal liability may arise where researchers:

Conduct prohibited reproductive embryo editing.

Perform unauthorised medical procedures.

Falsify clinical-trial or ethics approval documents.

Conduct experiments in violation of applicable statutory requirements.

Knowingly violate biosafety restrictions.

Cause legally recognised injury through criminal negligence.

In India, liability depends on the applicable provisions of the Environment (Protection) Act, 1986, the 1989 Biosafety Rules, the Drugs and Cosmetics Act, 1940 and other relevant legislation.

B. Civil liability

Researchers and biotechnology companies may face civil claims involving:

Negligence.

Defective medical products.

Failure to disclose material risks.

Lack of informed consent.

Breach of contractual obligations.

Personal injury.

Environmental damage.

For example, if an experimental CRISPR treatment causes an unintended genetic mutation because of inadequate safety procedures, the responsible institution or manufacturer may face liability depending on the evidence and applicable law.

C. Administrative liability

Regulatory authorities may impose:

Suspension of research activities.

Cancellation of licences.

Withdrawal of approvals.

Restrictions on clinical trials.

Seizure or destruction of unauthorised biological materials where legally authorised.

Financial penalties.

Restrictions on commercial distribution.

D. Institutional liability

Universities, hospitals and biotechnology companies may also face institutional consequences.

These include:

Failure to establish biosafety committees.

Inadequate supervision of researchers.

Improper ethics-review procedures.

Failure to maintain research records.

Failure to report adverse events.

Unauthorised use of biological samples.

8. Constitutional Dimensions of CRISPR Gene Editing Restrictions in India

The Indian Constitution provides important principles for regulating human genetic modification.

Article 21: Right to life and personal liberty

Article 21 is particularly significant.

It supports legal protection against unsafe and non-consensual genetic interventions.

It is also relevant to:

Reproductive autonomy.

Protection of genetic information.

Medical privacy.

Bodily integrity.

Informed consent.

However, Article 21 does not automatically establish an absolute constitutional right to demand access to every experimental gene-editing technology.

Article 14: Equality and genetic discrimination

Article 14 requires non-arbitrary state action.

Regulatory restrictions must have a rational and legally defensible basis.

It is relevant to preventing arbitrary distinctions between individuals based on genetic characteristics and to ensuring fair administration of biotechnology approval systems.

Article 19(1)(g): Scientific and commercial freedom

Biotechnology researchers and businesses may invoke Article 19(1)(g) in relation to lawful scientific and commercial activities.

However, this freedom is subject to reasonable restrictions under Article 19(6).

Public health, environmental protection and patient safety may justify appropriate regulatory restrictions.

9. Major Ethical and Legal Challenges

The regulation of CRISPR gene editing presents several unresolved legal questions.

The problem of intergenerational consent

One of the most difficult legal questions is whether present generations can authorise genetic modifications that affect future generations.

A person receiving somatic gene therapy may consent to the treatment and its known risks.

However, future descendants affected by germline editing cannot provide consent before the intervention occurs.

This raises questions of:

Future generations' rights.

Reproductive autonomy.

Human dignity.

Intergenerational justice.

State responsibility.

The problem of unequal access

CRISPR treatments may be expensive and technologically demanding.

If access is limited to wealthy individuals, genetic technologies could increase existing healthcare inequalities.

There is also a risk that genetic enhancement services could become commercially available without sufficient protection against exploitation and discrimination.

The problem of scientific uncertainty

Even where a gene-editing procedure appears successful, long-term consequences may remain uncertain.

Regulatory systems must therefore address:

Mosaicism.

Off-target effects.

Unintended chromosomal changes.

Immune reactions.

Long-term cancer risks.

Inherited genetic consequences.

10. Recommendations for Effective CRISPR Governance

A comprehensive regulatory framework should incorporate the following measures.

1. Clear statutory classification: Establish clear legal distinctions between somatic editing, non-reproductive embryo research and heritable reproductive editing.

2. Independent scientific review: Require qualified experts to evaluate safety, efficacy and genetic risks.

3. Mandatory ethics approval: Require independent ethical scrutiny of human research.

4. Informed consent: Ensure participants understand the nature, purpose, risks and limitations of experimental interventions.

5. Long-term monitoring: Establish appropriate follow-up mechanisms for patients receiving gene-editing treatments.

6. Genetic privacy protection: Prevent unauthorised collection, use and disclosure of genetic information.

7. Environmental risk assessment: Evaluate potential effects of gene-edited organisms before environmental release.

8. International cooperation: Develop compatible international standards for cross-border research and clinical applications.

9. Patent accountability: Balance biotechnology innovation with public access and statutory patentability requirements.

10. Criminal enforcement: Establish proportionate penalties for deliberate unauthorised reproductive experimentation, research fraud and serious biosafety violations.

11. Important Legal Provisions and Authorities for Examination

For India, the official DBT material also identifies the 2022 genome-edited plant guidelines and the 2017 recombinant DNA research and biocontainment framework.

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12. Conclusion

CRISPR gene editing represents a major development in modern biotechnology, but its applications require careful legal regulation.

The law must balance scientific freedom with human dignity, public health, environmental protection, reproductive autonomy and genetic privacy.

The He Jiankui case demonstrates that unauthorised reproductive gene editing can result in criminal prosecution. The Monsanto litigation demonstrates the importance of patent law in biotechnology. The Puttaswamy judgment provides constitutional principles for protecting genetic privacy, while Vellore Citizens' Welfare Forum and A.P. Pollution Control Board support precautionary environmental governance.

In India, the regulatory framework is distributed across environmental legislation, biosafety rules, pharmaceutical regulation, reproductive legislation and ethical guidelines.

The central legal principle is that scientific capability does not automatically create legal permission. CRISPR applications must satisfy the applicable requirements of safety, legality, informed consent, ethical oversight and public accountability.

13. Selected References and Primary Legal Sources

WHO – Human Genome Editing: Recommendations (2021).

WHO – Human Genome Editing: A Framework for Governance.

Australian Office of the Gene Technology Regulator – GMO Regulation.

Indian Department of Biotechnology – Biosafety and Genome Editing Guidelines.

China Supreme People's Court – He Jiankui Gene-Edited Babies Case.

Supreme Court of India – Monsanto v. Nuziveedu Seeds.

Supreme Court of India – K.S. Puttaswamy v. Union of India.

US Federal Circuit – Broad Institute v. Regents (2025).

Research note: The Indian Supreme Court decisions discussed above are relevant analogous precedents; they should not be represented as direct judgments specifically prohibiting CRISPR technology. The He Jiankui prosecution is a direct CRISPR-related criminal case. This distinction is important when preparing a legal dissertation or examination answer.