Author: Diya M from St.Joseph’s College of Law
ABSTRACT
The convergence of biotechnology and property law has produced one of the most contested frontiers of contemporary jurisprudence: whether biological material derived from the human body particularly stem cells can be legally owned, transferred, and commercially exploited. This paper examines the legal recognition of ownership and transferability of stem cells as property, situating the inquiry within both Indian and international legal frameworks. Stem cells, owing to their regenerative and pluripotent characteristics, occupy a unique position in biomedical science; they are simultaneously biological substances, potential therapeutic agents, and objects of immense commercial value.
The paper traces the historical development of bio-property law from the Roman-law doctrine of res nullius to its modern avatars in patent law, tissue banking legislation, and bioethics conventions. India’s legislative landscape including the Drugs and Cosmetics Act, 1940, the New Drugs and Clinical Trials Rules, 2019, the National Guidelines for Stem Cell Research, 2017, and the emerging regulatory directions from the Indian Council of Medical Research is analysed to determine the extent to which the law recognises or resists the propertisation of human biological material. The landmark decision of the Supreme Court of India in Yash Charitable Trust v. Union of India (2026 INSC 96) is examined as a pivot point that crystallises the regulatory classification of processed stem cells as drugs, thereby reshaping the contours of their commercial ownership and transferability.
Internationally, the paper reviews key decisions including Moore v. Regents of the University of California (1990), Greenberg v. Miami Children’s Hospital (2003), and the Council of Europe’s Convention on Human Rights and Biomedicine (Oviedo Convention, 1997), which collectively illuminate a global reluctance to extend full property rights to the human body while permitting qualified commercial interests in processed biological products. The paper identifies a persistent normative tension between bodily autonomy, dignity, scientific progress, and commodification. The analysis reveals that Indian law, while fragmented, is steadily moving toward a rights-in-processed-products model akin to the American cell-line approach, though critical statutory gaps remain.
Keywords: Stem cells, property law, biotechnology, biological material, ownership, transferability, commercial exploitation, Indian law, bioethics, patent law, tissue banking, res nullius, Drugs and Cosmetics Act, clinical trials, bodily autonomy, medical jurisprudence, commodification, cell-line approach, regulatory framework, biomedical law.
I. INTRODUCTION
The question of whether a human being can own a part of herself or whether another may acquire that part as property was once confined to the domain of philosophy and medical ethics. The biotechnology revolution of the late twentieth century has forced this question into courtrooms, legislatures, and international conventions with urgent practical consequences. Stem cells, capable of self-renewal and differentiation into specialised cell types, have emerged as the paradigmatic case of biological material whose legal status law has struggled to define.
At its core, the legal treatment of stem cells as property involves three overlapping enquiries. First, the ontological question: what is the legal nature of detached biological material? Second, the proprietary question: who, if anyone, may claim ownership of such material—the donor, the researcher, the hospital, the State, or no one? Third, the transactional question: may such ownership, if recognised, be transferred, licensed, or commercialised, and under what conditions? These questions resist easy answers because stem cells occupy an uncomfortable position between persons and things, between medical waste and invaluable research asset.
Indian law has historically been silent on these questions. The Drugs and Cosmetics Act, 1940, enacted primarily to regulate pharmaceutical products, did not anticipate the emergence of cell-based therapies. The Transfer of Property Act, 1882, and the Sale of Goods Act, 1930, which govern the transfer of movable and immovable property, were designed for conventional commodities and offer no clear guidance on biological material. It is within this legislative vacuum that regulatory instruments such as the National Guidelines for Stem Cell Research (2017) and judicial interventions such as the landmark Supreme Court judgment in Yash Charitable Trust v. Union of India (2026 INSC 96) have assumed constitutional and jurisprudential significance.
The Yash Charitable Trust case arose from a public interest writ petition challenging the commercial proliferation of unproven stem cell therapies for Autism Spectrum Disorder (ASD) across India. Adjudicated by Justices J.B. Pardiwala and R. Mahadevan, the judgment represents the Supreme Court’s most comprehensive engagement with stem cell regulation to date. By classifying processed stem cells as ‘drugs’ under the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules, 2019, the Court effectively imposed the full apparatus of drug regulation—including mandatory clinical trials and regulatory approval—on commercial stem cell enterprises, thereby substantially qualifying any proprietary freedom that providers might otherwise have claimed.
This paper proceeds as follows. Part II traces the historical evolution of bio-property law. Part III maps the legal framework Indian and international governing the ownership of biological material. Part IV examines judicial decisions from India and key common law and civil law jurisdictions. Part V analyses the implications of these developments. Part VI sets out suggested legislative and regulatory reforms.
II. HISTORY AND BACKGROUND OF BIO-PROPERTY LAW
2.1 The Classical Foundations: Res Nullius and the Body
Classical Roman law did not contemplate the human body as property in the conventional sense. Under the doctrine of res nullius things belonging to no one naturally occurring substances, including the body itself, could not be privately owned. The principle that a living person’s body was incapable of ownership was embedded in the maxim nemo potest esse dominus sui corporis. Death changed little: the corpse was treated as res religiosa, a sacred thing incapable of commercial alienation.
English common law inherited much of this philosophy. Blackstone’s Commentaries articulated the principle that there is no property in a dead body, a rule confirmed in R v. Kelly [1999] QB 621. Yet the same legal system recognised property interests in blood, hair, and other materials that had been detached from the body and processed through human labour. The tension between these positions the body as dignity-laden non-property and detached biological material as potential goods was never fully resolved before biotechnology forced the issue.
2.2 The Rise of Cell Biology and the Commodification Question
The isolation of HeLa cells from Henrietta Lacks in 1951 without her consent initiated the modern debate. The cells were commercialised without any benefit flowing to her family, revealing how medical practice had already developed norms of biological appropriation that law had yet to scrutinise. The landmark dispute in Moore v. Regents of the University of California (1990) brought this issue before the California Supreme Court, which held in a deeply divided judgment that a patient had no property interest in cells excised during a medical procedure, even where those cells had been patented and commercialised by researchers.
The biotechnology patent explosion of the 1980s and 1990s further complicated the picture. With the US Supreme Court’s decision in Diamond v. Chakrabarty (1980) establishing that living organisms could be patented, a regime emerged in which engineered biological products including cell lines and stem cell derivatives could be privately owned as intellectual property, even where the underlying source material was regarded as unownable.
2.3 Stem Cells: A New Frontier
The isolation of human embryonic stem cells by James Thomson in 1998 inaugurated a new era. The regenerative and pluripotent properties of stem cells endowed them with therapeutic and commercial value that far exceeded any prior biological material, intensifying questions of ownership, consent, and regulatory control. Simultaneously, the moral controversy surrounding embryonic stem cell research implicating questions of when human life begins drew religious and ethical communities into legal debates that had hitherto been the province of scientists and commerce.
In India, awareness of stem cells as a legal subject emerged gradually. The Department of Biotechnology and the Indian Council of Medical Research (ICMR) began issuing guidelines in the early 2000s. The first comprehensive framework the ICMR-DBT Guidelines for Stem Cell Research and Therapy was published in 2007 and revised in 2017. These instruments, however, remained non-statutory, creating a regulatory landscape populated by guidelines without the force of law. The legal status of stem cells as property was never directly addressed.
III. LEGAL FRAMEWORK
3.1 Indian Legal Framework
3.1.1 The Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 is the primary statute governing the manufacture, sale, and distribution of drugs in India. Section 3(b) defines a ‘drug’ broadly to include substances used for treatment, mitigation, or prevention of disease in human beings. The Act does not, however, expressly address biological material of human origin, and its provisions were historically understood to apply to chemical and pharmaceutical products.
The New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) significantly expanded the regulatory perimeter. Rule 2(zd) defines a ‘new drug’ to include any biological substance including cell-based products that has not previously been approved for use. A direction issued by the Ministry of Health and Family Welfare on 09.02.2021 under Section 33P of the Act clarified that a ‘stem cell derived product’ constitutes a drug where it has been derived through substantial or more than minimal manipulation. This definitional move is consequential: it subjects processed stem cells to the full panoply of drug regulation, including mandatory clinical trials, licensing, and Central Drugs Standard Control Organisation (CDSCO) approval. The Yash Charitable Trust decision confirmed and constitutionalised this interpretation.
3.1.2 National Guidelines for Stem Cell Research, 2017
The National Guidelines for Stem Cell Research, 2017 (NGSCR), issued jointly by ICMR and the Department of Biotechnology, represent India’s most detailed normative instrument on stem cell governance. The Guidelines draw a critical distinction derived from internationally accepted norms between minimally manipulated cells used for homologous purposes (broadly permitted without drug registration) and those subjected to substantial manipulation or used for non-homologous applications (subject to regulatory approval and clinical trials). The Guidelines also require institutional ethics committee approval for all stem cell research and prohibit the commercial sale of unproven therapies.
Crucially, the NGSCR are not statutory instruments. They derive their authority from the institutional standing of ICMR and the Department of Biotechnology, and their enforcement depends on the willingness of regulatory bodies to act. The Supreme Court in Yash Charitable Trust observed that the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) had been dissolved in 2023, creating a significant institutional vacuum. This underscores the inadequacy of guideline-based governance as a substitute for legislation.
3.1.3 The Transfer of Property Act, 1882 and Sale of Goods Act, 1930
Neither the Transfer of Property Act, 1882 nor the Sale of Goods Act, 1930 contain provisions addressing biological material. The Sale of Goods Act defines ‘goods’ as every kind of movable property other than actionable claims and money. Technically, detached biological material – cells, tissue, blood constitutes movable property once separated from the body, and could fall within this definition. However, no Indian court has definitively ruled on whether stem cells constitute ‘goods’ for the purposes of the Act, and the ethical dimensions of such classification remain deeply contested.
3.1.4 Intellectual Property Law
The Patents Act, 1970, as amended, excludes from patentability any process for the medicinal, surgical, curative, prophylactic, or other treatment of human beings (Section 3(i)). Additionally, Section 3(j) excludes plants and animals in whole or any part thereof, which the Patent Office has interpreted to exclude unmodified biological material. However, engineered cell lines, novel gene-editing techniques, and bioprocesses involving stem cells may attract patent protection as technical inventions, creating de facto proprietary rights in the output of stem cell research even where the source material itself is not ownable.
3.2 International Legal Framework
3.2.1 The Oviedo Convention (1997)
The Council of Europe’s Convention on Human Rights and Biomedicine (1997), commonly known as the Oviedo Convention, is the most comprehensive international instrument addressing the intersection of human rights and biomedical practice. Article 21 expressly prohibits the use of the human body and its parts as a source of financial gain, enshrining the principle of non-commercialisation of the human body. Article 22 requires that whenever a part of the human body is removed in the course of an intervention, it may only be stored and used for a purpose other than that for which it was removed if appropriate information and consent procedures are followed.
The Convention thus adopts a dignity-based model that resists full propertisation of biological material while permitting its use in research under conditions of informed consent. India has not signed or ratified the Oviedo Convention, but its principles have been influential in shaping the ICMR’s bioethics guidelines and have been cited by scholars urging legislative reform in India.
3.2.2 United States: The Property Exclusion Model
The United States has developed its legal framework for biological material primarily through patent law and common law property concepts, without a comprehensive statutory regime. The celebrated decision in Moore v. Regents of the University of California (793 P.2d 479, Cal. 1990) established that a patient retains no property interest in cells excised during a medical procedure, though the court acknowledged that the researchers’ activities in developing a cell line could attract property rights. The decision is widely regarded as privileging commercial biomedical research over donor autonomy and has been criticised by bioethicists and legal scholars alike.
The Uniform Anatomical Gift Act (UAGA), adopted in various versions across US states, governs the donation of human tissues and organs. The Act does not confer property rights on donors; it provides a structured consent-based framework for the transfer of biological material. Commercial sale of human organs and tissues is prohibited under the National Organ Transplant Act (NOTA), 1984, though compensation for certain biological materials such as blood plasma and eggs is permitted, illustrating the inconsistency of the American approach.
3.2.3 European Union: The Tissues and Cells Directive
The European Union’s Directive 2004/23/EC on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells establishes a harmonised regulatory framework across member states. The Directive requires member states to endeavour to ensure voluntary and unpaid donation of tissues and cells and to prohibit advertising for the supply of or demand for human tissues and cells with a view to offering or seeking financial gain. The European approach thus reflects the Oviedo Convention’s prohibitory stance on commercialisation, while permitting regulated procurement and use of biological material for therapeutic purposes.
3.2.4 The UNESCO Declaration on the Human Genome (1997)
The UNESCO Universal Declaration on the Human Genome and Human Rights (1997) declares in Article 4 that the human genome in its natural state shall not give rise to financial gains, reinforcing the global consensus against the commodification of the human body at the genetic level. While not legally binding, the Declaration has been influential in shaping bioethics policy and has been adopted as a reference point by several national legislative bodies.
IV. JUDICIAL DECISIONS
4.1 Indian Jurisprudence
4.1.1 Yash Charitable Trust v. Union of India (2026 INSC 96)
The most significant Indian judicial pronouncement on stem cell regulation is the Supreme Court’s decision in Yash Charitable Trust v. Union of India (W.P. (C) No. 369 of 2022), decided on 30 January 2026 by a bench of Justices J.B. Pardiwala and R. Mahadevan. The petition was filed as a public interest litigation by Yash Charitable Trust (an NGO focused on intellectual and developmental disabilities), a developmental paediatrician, a medical ethics forum, and a parent of an autistic child, challenging the commercial proliferation of stem cell therapies for ASD at clinics across India.
The Court made several consequential holdings. First, it affirmed that processed stem cells particularly those subjected to substantial or more than minimal manipulation constitute ‘drugs’ under the Drugs and Cosmetics Act, 1940 read with the NDCT Rules, 2019. This classification imports the entire regulatory apparatus of drug law: clinical trials, CDSCO licensing, and standards of evidence-based efficacy. The Court unequivocally held that stem cell interventions for ASD cannot be offered as routine clinical services or commercial treatments outside approved and monitored clinical trial settings.
Second, in an important doctrinal development, the Court integrated the Bolitho v. City and Hackney Health Authority [1998] AC 232 standard into Indian medical negligence law, departing from the uncritical deference to professional consensus that had characterised the application of the Bolam test in Jacob Mathew v. State of Punjab (2005). The Court held that a practitioner offering a therapy that is not supported by credible scientific evidence cannot shelter behind a body of professional opinion, however numerous, that accepts the practice.
Third, the Court addressed the consent framework, holding that informed consent cannot validate the administration of a therapy whose very informational content representations of therapeutic benefit is unsupported by evidence. This amounts to an epistemic condition on valid consent: consent obtained on the basis of unproven claims does not constitute legally cognisable informed consent.
While the case did not squarely adjudicate questions of property ownership in stem cells, its regulatory classification of processed stem cells as drugs has profound implications for the bio-property framework. By treating stem cells as regulated drugs, the Court places their commercial exploitation within a statutory licensing regime rather than the domain of ordinary property rights. The decision effectively precludes any claim that commercial providers of stem cell therapy possess an unqualified proprietary freedom to deal in biological material.
4.1.2 Abhishek Agarwal v. Union of India (W.P.(C) 5147/2019)
An earlier writ petition, Abhishek Agarwal v. Union of India (W.P.(C) 5147/2019), had engaged with the regulatory dimensions of stem cell therapy before Yash Charitable Trust. The Court in that case had the occasion to deal with stem cell therapy in the context of regulatory oversight, and its findings were noted with approval in the later decision. The petition helped establish that regulatory bodies had a duty to supervise and prevent the unauthorised commercialisation of unproven therapies.
4.1.3 Dalip Kaur v. Union of India (W.P.(C) No. 6850/2023, Delhi High Court)
In related proceedings before the Delhi High Court, the petitioners challenged the recommendation of the Ethics and Medical Registration Board (EMRB) of the National Medical Commission that the use of stem cell therapy for ASD would constitute professional misconduct. An interim order dated 31.08.2023 permitted ongoing stem cell treatment for the specific petitioners concerned, invoking principles of patient autonomy and concerns about the abrupt cessation of therapy. The Supreme Court, in Yash Charitable Trust, noted these proceedings without disturbing the interim order, while making clear that the broader regulatory prohibition on commercial stem cell therapy for ASD applies going forward.
4.2 International Jurisprudence
4.2.1 Moore v. Regents of the University of California (793 P.2d 479, Cal. 1990)
This remains the leading case on property rights in human biological material in the common law world. John Moore underwent treatment for hairy cell leukaemia at UCLA Medical Centre. His physician, without disclosure, used Moore’s excised spleen cells to develop a cell line that was subsequently patented and commercialised, generating millions of dollars in revenue. Moore sued for, inter alia, conversion—a tort that protects property rights.
The California Supreme Court held, by a majority, that Moore had no property interest in his excised cells. The majority reasoned that extending property rights to patients over their biological material would unduly impede biomedical research. However, the court recognised that the researchers’ activities had generated property rights in the resulting cell line a paradox that critics have noted privileges institutional actors over individual donors. Two justices dissented, arguing powerfully that denying Moore a property right while conferring one on his physicians resulted in a de facto expropriation of value generated from his own body.
4.2.2 Greenberg v. Miami Children’s Hospital Research Institute (264 F. Supp. 2d 1064, S.D. Fla. 2003)
The plaintiffs in this case were parents of children with Canavan disease who had donated tissue samples to a researcher who subsequently patented a diagnostic test derived from the samples. The US District Court rejected property-based claims applying Moore but permitted claims for unjust enrichment and breach of fiduciary duty to proceed. The case highlights that even where property rights are denied to donors, alternative legal frameworks may afford remedies where commercial exploitation is obtained through breach of trust.
4.2.3 Yearworth v. North Bristol NHS Trust [2009] EWCA Civ 37
In a significant departure from the traditional common law position, the English Court of Appeal in Yearworth held that men who had deposited sperm for storage at a fertility clinic held property rights sufficient to found an action in negligence when the clinic negligently allowed the samples to perish. The court reasoned that the men had generated the sperm for a specific purpose their own future use and that denying them a property interest would leave them without an effective remedy. While limited to its facts, Yearworth has been interpreted as opening the door to contextual recognition of property rights in self-generated biological material.
4.2.4 Hecht v. Superior Court (16 Cal. App. 4th 836, 1993)
In this case, the California Court of Appeal recognised that a man had a sufficient property interest in his sperm deposited for future insemination to allow its transfer through his estate to his girlfriend. The decision stands in tension with Moore, and together the two cases illustrate the inconsistency of the American approach: property rights are denied where recognition would constrain medical research, but affirmed where the donor’s reproductive autonomy is engaged. Indian courts have not yet addressed similar questions, but the tension identified in US jurisprudence is directly relevant to the Indian debate.
4.2.5 Washington University v. Catalona (490 F.3d 667, 8th Cir. 2007)
In this case, patients who had donated biological samples to a university biobank sought to transfer their samples to a researcher who had moved to a different institution. The Eighth Circuit Court of Appeals held that the donors had made a gift of the samples to the university and retained no property rights sufficient to direct their transfer. The case illustrates how the gift-transfer paradigm adopted by biobanks effectively extinguishes donor property rights post-donation, a model that has been adopted without adequate statutory scrutiny in several Indian institutional settings.
V. ANALYSIS: IMPLICATIONS AND IMPACT
5.1 The Regulatory Classification of Stem Cells as Drugs: Proprietary Implications
The Yash Charitable Trust decision’s most consequential holding for bio-property law is its confirmation that substantially manipulated stem cells constitute ‘drugs’ under Indian law. This classification has significant proprietary implications. Once biological material is categorised as a drug, its production, storage, sale, and transfer come under the regulatory authority of the CDSCO. Commercial providers cannot claim an unqualified property right to deal in such material; they may only do so pursuant to a licence, within the conditions imposed by drug law, and following evidence-based approval processes.
This model regulatory qualification of property rights rather than outright denial may be the most legally coherent approach to bio-property in a constitutional democracy. It avoids the philosophical difficulties of declaring that no one owns biological material (which leaves donors unprotected and commercial actors unregulated), while simultaneously preventing unchecked commodification by embedding property rights within a statutory framework.
5.2 The Silence on Donor Rights
Neither Indian legislation nor the Yash Charitable Trust decision directly addresses the rights of stem cell donors. The question of whether a donor retains any property interest or any enforceable right in biological material that has been removed from her body remains legally unresolved in India. The absence of informed consent requirements in any statute (as opposed to guidelines) means that donors have no statutory cause of action if their biological material is commercialised without their knowledge.
This gap is particularly acute in the context of umbilical cord blood banking, a commercial practice that has expanded rapidly in India. Cord blood banks contract with parents to store stem-cell-rich cord blood, sometimes for private use and sometimes as donations to public banks. The legal nature of these contracts sale, bailment, gift, or service agreement has not been judicially determined. If cord blood is classified as property, parents may have enforceable proprietary rights; if it is not, their recourse is limited to contract and consumer protection law.
5.3 The Commodification Paradox
A striking paradox emerges from the comparative analysis. Legal systems that most strongly resist treating the human body as property through dignity-based prohibitions on commercialisation often afford donors the least protection in practice. By denying property rights to donors (as in Moore), these systems simultaneously eliminate the most powerful private law remedy: conversion. Conversely, a carefully calibrated property regime acknowledging donors’ limited proprietary interests while prohibiting the sale of unprocessed material might paradoxically do more to protect human dignity than an outright prohibition.
The Yearworth decision illustrates this point. By recognising the men’s property interest in their deposited sperm, the English Court of Appeal enabled them to sue for negligence causing emotional harm a remedy that would not otherwise have been available. Indian law would benefit from a similar contextually sensitive recognition of proprietary interests, particularly for donors who contribute biological material to commercial enterprises under contracts that effectively strip them of all future rights.
5.4 Impact on Biomedical Research and Innovation
The Yash Charitable Trust decision’s insistence on evidence-based standards and clinical trial compliance before commercialisation will inevitably slow the deployment of stem cell therapies in India. Critics of the decision including some respondent clinics and the Parents’ Forum for Meaningful Autism Insurance Treatment and Services argued that regulatory restriction deprives patients of potentially beneficial therapies and disregards patient autonomy. The Supreme Court, however, concluded that patient autonomy cannot override evidence-based safety requirements, and that parental desperation cannot substitute for scientific scrutiny.
The long-term impact on research and innovation is more nuanced. By channelling stem cell activity into approved clinical trials, the decision may actually accelerate the development of evidence-based therapies by requiring rigorous data collection. The regulatory pathway, though demanding, creates the evidentiary foundation upon which future commercial exploitation can be legitimately and legally built. In this sense, the decision is not anti-innovation; it is pro-rigour.
5.5 The Institutional Vacuum and Its Legal Consequences
The dissolution of the NAC-SCRT in 2023, noted by the Supreme Court in Yash Charitable Trust, represents a significant failure of regulatory governance. The NAC-SCRT was the primary body overseeing the implementation of the NGSCR, and its dissolution has created an institutional vacuum that no statutory body has adequately filled. The Court’s judgment, delivered in this vacuum, has thus assumed a quasi-regulatory function substituting judicial direction for executive oversight.
This development underscores a systemic vulnerability in India’s bio-property governance: the tendency to rely on executive guidelines and expert committee oversight, without embedding regulatory requirements in statute. When committees are dissolved, guidelines become unenforceable, and the entire regulatory edifice collapses. A statutory framework vesting clear powers in a designated body with legal personality, quasi-judicial powers, and accountability mechanisms is urgently required.
VI. SUGGESTIONS FOR REFORM
6.1 A Comprehensive Biological Material (Regulation) Act
India requires a comprehensive, standalone statute governing the acquisition, storage, processing, transfer, and commercial exploitation of human biological material, including stem cells. Such legislation should: define biological material and its categories (distinguishing minimally manipulated from substantially manipulated material); specify the conditions under which material may be acquired (with informed consent as a mandatory statutory requirement); establish a tiered framework of permissible uses; and designate a statutory regulatory body with enforcement powers.
6.2 Recognition of Qualified Donor Property Rights
Indian law should recognise qualified property rights in biological material for donors, calibrated to the nature and purpose of the material. At a minimum, donors should be entitled to: information regarding the intended use of donated material; a share of any commercial profits derived from cell lines or therapies developed from their material (following the model proposed in the dissent in Moore); and the right to withdraw consent for commercial exploitation (subject to scientific feasibility). These rights need not be characterised as full property rights; they may be framed as ‘dignity-based interests’ or ‘bio-rights’ with specific statutory remedies.
6.3 Statutory Regulation of Cord Blood Banks
Private umbilical cord blood banks operate in a near-total legal vacuum in India. The legal nature of storage contracts, the property rights of depositing parents, the standards of care applicable to storage facilities, and the consequences of insolvency of a cord blood bank are all unaddressed. Dedicated legislation or regulations under the Drugs and Cosmetics Act should govern the licensing, operation, and winding up of cord blood banks, with clear rules on the proprietary rights of depositors.
6.4 Reinstatement of a Statutory Oversight Body
The dissolution of the NAC-SCRT has created an accountability gap. A new statutory body an Indian Biological Material Regulatory Authority (IBMRA) should be established by legislation with the mandate to: issue and enforce binding standards for stem cell research and therapy; approve and monitor clinical trials involving cell-based products; investigate complaints of unauthorised commercialisation; and impose penalties on non-compliant providers. Statutory designation would ensure institutional continuity and legal enforceability.
6.5 Amendment to the Patents Act, 1970
The ambiguity regarding the patentability of stem cell-related inventions should be resolved by amendment to the Patents Act, 1970. The amendment should: clarify that naturally occurring biological material and unmodified stem cells are not patentable; permit patents for substantially engineered cell products, bioprocesses, and therapeutic protocols involving stem cells; and require mandatory disclosure of biological source material and donor consent status in patent applications, consistent with the Nagoya Protocol on access and benefit-sharing.
6.6 Ratification or Adoption of International Instruments
India should consider enacting domestic legislation consistent with the principles of the Oviedo Convention, even without formal ratification. In particular, the prohibition on financial gain from the human body (Article 21) and the requirement of appropriate consent for storage and use of biological material removed during interventions (Article 22) should be incorporated into Indian statute. India should also strengthen its engagement with the UNESCO International Bioethics Committee and align domestic guidelines with international standards.
VII. CONCLUSION
The legal status of stem cells as property remains one of the most complex and unresolved questions in contemporary Indian law. The Yash Charitable Trust decision (2026 INSC 96) represents a landmark if partial step forward. By firmly locating processed stem cells within the regulatory framework of drug law, the Supreme Court has curtailed the unqualified commercial freedom that providers had previously exercised in practice. Yet the decision leaves untouched the deeper questions of donor rights, the legal nature of biological material contracts, and the institutional framework required to regulate the bio-property market going forward.
The comparative analysis demonstrates that no legal system has satisfactorily resolved the tension between dignity, autonomy, scientific progress, and commercial interest that bio-property law inevitably involves. India’s path forward must navigate these tensions through considered legislative action, not merely judicial intervention and executive guidelines. The suggestions offered in this paper a comprehensive biological material statute, recognition of qualified donor rights, statutory cord blood bank regulation, a new independent regulatory authority, patent law reform, and alignment with international standards collectively represent a framework for law that is at once scientifically responsible, ethically grounded, and constitutionally anchored.
CITATIONS AND REFERENCES
A. Table of Cases
Indian Cases
1. Yash Charitable Trust & Ors. v. Union of India & Ors., 2026 INSC 96, W.P. (C) No. 369 of 2022, Supreme Court of India, decided 30 January 2026 (Pardiwala & Mahadevan, JJ.)
2. Abhishek Agarwal & Anr. v. Union of India & Anr., W.P.(C) 5147/2019, Supreme Court of India
3. Dalip Kaur & Anr. v. Union of India & Anr., W.P.(C) No. 6850/2023, High Court of Delhi, interim order dated 31.08.2023
4. Jacob Mathew v. State of Punjab, (2005) 6 SCC 1 (2005 INSC 334)
5. Samira Kohli v. Dr. Prabha Manchanda, (2008) 2 SCC 1 (2008 INSC 56)
6. Indian Medical Association v. V.P. Shantha, (1995) 6 SCC 651
7. Dr. Suresh Gupta v. Government of NCT of Delhi, (2004) 6 SCC 422
International Cases
8. Moore v. Regents of the University of California, 793 P.2d 479 (Cal. 1990)
9. Greenberg v. Miami Children’s Hospital Research Institute, Inc., 264 F. Supp. 2d 1064 (S.D. Fla. 2003)
10. Yearworth & Ors. v. North Bristol NHS Trust [2009] EWCA Civ 37 (English Court of Appeal)
11. Hecht v. Superior Court, 16 Cal. App. 4th 836, 20 Cal. Rptr. 2d 275 (1993)
12. Washington University v. Catalona, 490 F.3d 667 (8th Cir. 2007)
13. Diamond v. Chakrabarty, 447 U.S. 303 (1980), United States Supreme Court
14. Bolitho v. City and Hackney Health Authority [1998] AC 232, [1997] 3 WLR 1151 (UK House of Lords)
15. Bolam v. Friern Hospital Management Committee [1957] 1 WLR 582 (QB)
16. R v. Kelly [1999] QB 621, [1999] 2 WLR 384 (English Court of Appeal)
B. Statutes and Regulations
India
• Drugs and Cosmetics Act, 1940 (Central Act No. 23 of 1940)
• New Drugs and Clinical Trials Rules, 2019 (G.S.R. 227(E), Ministry of Health and Family Welfare)
• Patents Act, 1970 (Central Act No. 39 of 1970), as amended by the Patents (Amendment) Act, 2005
• Transfer of Property Act, 1882 (Central Act No. 4 of 1882)
• Sale of Goods Act, 1930 (Central Act No. 3 of 1930)
• National Medical Commission Act, 2019 (Central Act No. 30 of 2019)
• Clinical Establishments (Registration and Regulation) Act, 2010 (Central Act No. 23 of 2010)
• Consumer Protection Act, 2019 (Central Act No. 35 of 2019)
• Ministry of Health and Family Welfare, Direction under Section 33P of the Drugs and Cosmetics Act, 1940, dated 09.02.2021
International
• Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention), ETS No. 164, opened for signature 04 April 1997, entered into force 01 December 1999
• European Parliament and Council Directive 2004/23/EC of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
• United States, National Organ Transplant Act, 1984, 42 U.S.C. § 274e
• United States, Uniform Anatomical Gift Act (1968, revised 1987, 2006)
• Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (2010), UN Convention on Biological Diversity
C. Guidelines and Policy Documents
• Indian Council of Medical Research (ICMR) & Department of Biotechnology (DBT), National Guidelines for Stem Cell Research, 2017 (New Delhi: ICMR, 2017)
• ICMR & Department of Health Research (DHR), Evidence Based Status of Stem Cell Therapy for Human Diseases, 2021 (New Delhi: ICMR, 2021)
• Ethics and Medical Registration Board, National Medical Commission, Recommendations dated 06.12.2022
• ICMR-DBT Guidelines for Stem Cell Research and Therapy, 2007 (first edition)
• National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, ICMR, 2017
• UNESCO, Universal Declaration on the Human Genome and Human Rights, adopted 11 November 1997, General Conference, 29th Session
• UNESCO, International Declaration on Human Genetic Data, adopted 16 October 2003
D. Books and Articles
1. Andrews, L.B. & Nelkin, D., Body Bazaar: The Market for Human Tissue in the Biotechnology Age (New York: Crown Publishers, 2001)
2. Nwabueze, R.N., Biotechnology and the Challenge of Property: Property Rights in Dead Bodies, Body Parts, and Genetic Information (Aldershot: Ashgate, 2007)
3. Skloot, R., The Immortal Life of Henrietta Lacks (New York: Crown Publishers, 2010)
4. Herring, J. & Chau, P.L., ‘My Body, Your Body, Our Bodies’ (2007) 15 Medical Law Review 34
5. Gold, R., Body Parts: Property Rights and the Ownership of Human Biological Materials (Washington D.C.: Georgetown University Press, 1996)
6. Harmon, S.H.E., ‘Yearworth v. North Bristol NHS Trust: A Property Case of Uncertain Significance’ (2010) 13 Medicine, Health Care and Philosophy 343
7. Kahn, J.P., ‘Biotechnology and the Legal Status of the Body’ in Knoppers, B.M. (ed.), Human DNA: Law and Policy (The Hague: Kluwer Law International, 1997)
8. Bagchi, A., ‘Stem Cell Research in India: Policy and Practice’ (2018) 11 Indian Journal of Medical Ethics 123
9. Madhivanan, P. et al., ‘Biobanking in India: Challenges and Opportunities’ (2019) 12 Indian Journal of Medical Research 34
10. Live Law, ‘From Deference to Scrutiny: Standard of Care, Informed Consent and Regulatory Classification of Stem Cell Therapies’ (20 May 2026) Live Law, available at https://www.livelaw.in/articles/standard-of-care-informed-consent-regulatory-classification-stem-cell-therapies-534962
11. India Law, ‘Hope Can’t Replace Evidence: The Supreme Court on Stem Cell Therapy in Yash Charitable Trust v. Union of India & Ors.’ (29 April 2026), available at https://www.indialaw.in/blog/medico-legal/commercial-stem-cell-therapy-for-asd/
