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In November 2018, a Chinese biophysicist named He Jiankui announced to the world that he had successfully edited the germline of two human embryos twins, later named Lulu and Nana using the CRISPR-Cas9 gene-editing tool. The global scientific community responded with near-universal condemnation. He was jailed. The twins carry heritable genetic modifications that will, if they have children, pass into the next generation. The change cannot be undone.

That episode felt like science fiction then. It is rapidly becoming science policy today. Across laboratories in the United States, China, and Europe, germline editing is no longer a theoretical proposition. CRISPR-based therapies are in clinical use for somatic conditions sickle cell disease, beta-thalassemia and the commercial pressure to push further into germline applications grows each year. India, which has one of the highest rates of hereditary blood disorders in the world, is not a passive bystander in this story.

If a human embryo is subjected to non-consensual germline editing whether in a private fertility clinic, a research laboratory, or through a future commercial service does India's constitutional framework under Article 21 offer any remedy? The short answer is it should, but the machinery to make that protection real does not yet exist.

What CRISPR Does and Why Germline Editing Is Different

Gene editing is not new. What CRISPR-Cas9 changed is precision and cost. It allows scientists to target a specific sequence of DNA and cut, delete, or replace it with extraordinary accuracy. When this is done to somatic cells in a living patient's body the modifications affect only that person. They are non-heritable. This is the basis of approved therapies like Casgevy, the world's first CRISPR-based gene therapy, approved by the US FDA in December 2023 for sickle cell disease.

Germline editing is categorically different. When the edit is made to a sperm, egg, or early-stage embryo, every cell in the resulting human being carries the modification and so will their biological children. The intervention precedes consent. The person most affected by the edit does not yet exist at the moment the edit is made. This is precisely what makes it constitutionally fraught.

India's Regulatory Position: Guidelines Without Statute

India has not ignored this question entirely. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, issued by the Indian Council of Medical Research (ICMR), prohibit human germline editing and reproductive cloning. The National Guidelines for Stem Cell Research reinforce this prohibition. The ICMR's Gene Therapy Guidelines, 2019, recommend the creation of an independent Gene Therapy Advisory and Evaluation Committee (GTAEC) to supervise such research.

More recently, in June 2026, the Government enacted the Drugs (Eighth Amendment) Rules, 2026, bringing cell and gene therapy products under the Centrally License Approving Authority (CLAA) framework a significant regulatory step. The Ministry of Health had signalled this direction through a draft Gazette notification in October 2025, and the Rules came into force on 29 June 2026.

But here is the problem. None of this is statute. The ICMR guidelines, however carefully worded, are advisory instruments. They impose no criminal penalty. They create no civil cause of action. A private clinic that edits an embryo in violation of the ICMR guidelines faces administrative consequences at most, loss of accreditation but no victim can walk into a court and invoke them as the basis of a constitutional or tortious claim. The Drugs (Eighth Amendment) Rules regulate the licensing of gene therapy products; they do not define non-consensual germline editing as an offence, nor do they establish a victim's right to remedy.

India, as the Global Gene Editing Regulation Tracker notes, has bans that exist but “do not necessarily have legal enforcement mechanisms behind them.” That is the regulatory reality. The question is whether the Constitution can fill this gap.

Article 21 and the Bodily Integrity Strand

Article 21 of the Constitution guarantees that no person shall be deprived of life or personal liberty except according to procedure established by law. In Justice K.S. Puttaswamy v. Union of India (2017), a nine-judge bench of the Supreme Court unanimously held that the right to privacy is an intrinsic fundamental right under Article 21. Critically, the Court did not read privacy as a single monolithic right. It identified several distinct zones and one of them was bodily integrity.

Justice D.Y. Chandrachud, writing for four judges, grounded privacy in “bodily and mental integrity” (para 168), dignity, and personal autonomy. The right to control one's own body its physical inviolability is now settled constitutional doctrine. This is not a peripheral observation. It is the foundation of cases like Suchita Srivastava v. Chandigarh Administration (2009), where the Supreme Court held that a woman's reproductive choices were protected under Article 21, and Selvi v. State of Karnataka (2010), which held that compelled narco-analysis violated bodily integrity.

The constitutional architecture, then, already supports the proposition that the body its physical composition, its biological identity is a zone of constitutionally protected privacy. The question is whether that protection extends to the genome the most intimate expression of biological selfhood.

Can the Genome Be a Constitutional Interest?

The argument that the genome is a constitutional interest under Article 21 rests on three propositions.

First, the genome is the body. DNA is not merely information about a person it is the biological substrate of who that person is. An edit to the germline is not an informational intrusion; it is a physical alteration of the body's foundational structure, heritable and permanent. If Article 21 protects bodily integrity, it must at minimum protect against alterations that are irreversible and pre-consent.

Second, the person who will be most affected by a germline edit the child born from the edited embryo cannot consent. Constitutional rights are not contingent on the capacity to assert them at the moment of violation. The Court in Parmanand Katara v. Union of India (1989) affirmed that the state has a positive duty to protect life. An embryo subjected to non-consensual germline editing is not a rights-holder under current Indian law, but the person that embryo becomes is and that person will live with an irreversible constitutional injury they never agreed to.

Third, Puttaswamy's proportionality standard that any state or private interference with privacy must be lawful, necessary, and proportionate is directly applicable. A germline edit performed without statutory authorisation, without a framework for informed consent, and without any mechanism for post-birth remedy fails all three limbs of this standard simultaneously.

The Horizontal Effect Problem

There is an honest difficulty here. Most germline editing will not be done by the state. It will be done by private fertility clinics, private research laboratories, or (as gene editing costs fall) private commercial actors. Fundamental rights under Part III of the Constitution traditionally bind the state and its instrumentalities, not private parties.

However, this is not an insurmountable objection. The Supreme Court in Kaushal Kishor v. State of Uttar Pradesh (2023) opened the door tentatively but meaningfully to horizontal application of fundamental rights between private parties. More directly, the state's failure to legislate a statutory prohibition on non-consensual germline editing is itself a state action or rather, a state omission that a constitutional court can address through a declaration of legislative incompleteness and a mandamus to Parliament.

The gap is not just regulatory. It is constitutional. When the state permits a zone of human vulnerability to remain entirely unprotected where an irreversible bodily alteration can be performed without consent, without remedy, and without criminal liability that omission is itself amenable to Article 21 scrutiny.

What Legislation Must Do

The answer to non-consensual germline editing is not another ICMR guideline. It is a statute one that does at least four things.

One, it must define germline editing as a regulated act and classify non-consensual germline editing as a criminal offence with meaningful penalties not merely a licensing violation.

Two, it must create a statutory independent body the GTAEC that ICMR has recommended since 2019 remains non-operational with powers to authorise, monitor, and penalise germline research.

Three, it must provide a civil remedy. A person born with non-consensually altered genetic material must have a statutory cause of action independent of criminal proceedings against the institution or individual responsible.

Four, it must address the consent architecture for embryo research specifically. The Assisted Reproductive Technology (Regulation) Act, 2021 regulates IVF clinics and requires informed consent for embryo use but it is silent on the specific scenario of genetic modification. A targeted amendment, or a standalone Genomic Integrity Act, is needed.

The constitutional question at the heart of this piece is not speculative. CRISPR is no longer a laboratory curiosity. India's gene therapy market is growing at over 15 percent annually. Private fertility clinics proliferate, regulated unevenly across states. The technology to edit a human embryo's germline exists, is accessible, and is becoming cheaper.

Article 21, as interpreted through Puttaswamy, already contains the doctrinal material for a right against non-consensual germline editing: bodily integrity, informational privacy, reproductive autonomy, and the proportionality test. What it does not yet have is a statute that operationalises these protections before the harm occurs because constitutional litigation is, by its nature, retrospective.

Lulu and Nana, the CRISPR twins are now children in China, living with edits they did not consent to, whose long-term consequences remain unknown. India should not wait for its own version of that story before it decides what the Constitution requires.

Author Raghvendra Kumar Chaudhary is an Assistant Professor at CHRIST (Deemed to be University), Delhi NCR Campus & Navneet Raj Singh is a Law student at CHRIST (Deemed to be University), Delhi NCR Campus. Views are personal.

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