1. Introduction

Cross-border shipment of unapproved cell products is an important area of biotechnology, pharmaceutical, international trade and public health law. It concerns the importation, exportation, transportation, distribution or delivery of cellular materials that have not received the marketing authorisation, regulatory approval or other legal permission required in the destination country.

Cell products may include:

Stem-cell products, including embryonic and adult stem cells.

Mesenchymal stem-cell (MSC) preparations.

Genetically modified cellular therapies.

CAR-T cells and other engineered immune-cell products.

Cultured human cells and tissue-based products.

Cell-derived regenerative medicine products.

Human cellular products intended for transplantation.

Unapproved autologous and allogeneic cell therapies.

The legal problem becomes particularly complex when a product is manufactured in one country, shipped through another country and administered to a patient in a third country.

A product that is lawfully manufactured in the exporting country is not automatically lawful to import, market or administer in another jurisdiction.

The central enforcement objective is to prevent unsafe or inadequately tested cellular products from entering the healthcare system while preserving legitimate scientific research, clinical trials, compassionate access and lawful transplantation activities.

2. Meaning and legal classification of unapproved cell products

The first enforcement question is whether the shipped material is legally classified as a drug, biological product, advanced therapy medicinal product (ATMP), human tissue product or investigational medicinal product.

Classification determines the regulatory authority, import licence, manufacturing standards, clinical-trial requirements and available enforcement powers.

A. Unapproved cell products

A cell product may be considered unapproved when:

It has not received the required marketing authorisation.

Its clinical-trial import permission is absent.

Its manufacturing process has not received the necessary regulatory approval.

It is imported for an unauthorised therapeutic purpose.

It fails applicable safety, identity, purity or potency standards.

It is falsely described as a research sample to avoid medicinal-product controls.

B. Important distinction: unapproved does not always mean illegal

A cell product may lawfully cross a border under a specific regulatory pathway even though it has not received general marketing approval.

Examples include:

Importation for an authorised clinical trial.

Importation for laboratory examination or scientific analysis.

Special patient-access or compassionate-use arrangements.

Lawful transplantation of qualifying human tissues or cells.

Personalised cellular therapies permitted under a specific regulatory exemption.

Consequently, enforcement authorities must distinguish commercial distribution from legitimate research and authorised clinical use.

3. International regulatory framework

A. United States

The principal legislation includes:

Federal Food, Drug, and Cosmetic Act (FDCA).

Public Health Service Act (PHSA).

21 CFR Part 1271 – Human Cells, Tissues, and Cellular and Tissue-Based Products.

21 CFR Parts 210 and 211 – Good Manufacturing Practices.

21 CFR Part 312 – Investigational New Drug applications.

21 CFR Part 600 – Biological products.

The US Food and Drug Administration (FDA) regulates cell products depending on their characteristics and intended uses.

Under the HCT/P framework, certain minimally manipulated products intended for homologous use may qualify for a less burdensome regulatory pathway. Products that fail the applicable criteria may be regulated as drugs or biological products requiring premarket authorisation.

The FDA can intervene when an imported product is misbranded, adulterated, improperly manufactured or imported without the necessary authorisation.

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Enforcement measures include:

Detention at the port of entry.

Refusal of admission.

Re-exportation or destruction.

Import alerts.

Seizure.

Civil injunctions.

Warning letters.

Criminal prosecution in appropriate cases.

B. European Union

The principal regulatory framework includes:

Regulation (EC) No. 1394/2007 on Advanced Therapy Medicinal Products.

Directive 2001/83/EC on medicinal products for human use.

Regulation (EU) No. 536/2014 on clinical trials.

Directive 2004/23/EC on human tissues and cells.

Directive 2006/17/EC on technical requirements for donation, procurement and testing of human tissues and cells.

Directive 2006/86/EC on traceability and notification of serious adverse reactions and events.

Cell-based medicinal products that meet the ATMP definition are subject to the applicable authorisation and quality requirements.

The European Medicines Agency (EMA), its Committee for Advanced Therapies (CAT), national competent authorities and customs authorities have complementary responsibilities.

A particularly important distinction exists between:

Cell products regulated as ATMPs.

Human tissues and cells regulated under the tissue-and-cell framework.

Products falling within specific exclusions or exemptions.

The hospital exemption is not a general permission to import and commercially distribute unapproved cell products. It is a narrowly controlled national exemption for qualifying ATMPs prepared on a non-routine basis under specific conditions.

C. India

India is particularly important because the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019 provide the central framework for regulating cell and stem-cell-derived products.

The principal authorities and instruments include:

Central Drugs Standard Control Organisation (CDSCO).

Drugs Controller General of India (DCGI).

Drugs and Cosmetics Act, 1940.

Drugs Rules, 1945.

New Drugs and Clinical Trials Rules, 2019.

Applicable clinical-trial permissions and import licences.

National Guidelines for Stem Cell Research, 2017, as applicable.

The 2022 amendment expressly substituted the expression cell or stem cell derived product in the New Drugs and Clinical Trials Rules, 2019.

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Under this framework, regulatory approval and permission depend on the product's classification and proposed purpose.

Importation of an unapproved product is not automatically permissible merely because it has been approved in the country of export.

The New Drugs and Clinical Trials Rules contain specific provisions for importing investigational drugs and certain unapproved drugs for treatment in government hospitals or government medical institutions.

For example, Rules 86 and 87 provide a special pathway for qualifying unapproved new drugs intended for patients with life-threatening diseases, serious permanent disabilities or unmet medical needs. This is not a blanket exemption for commercial importers.

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An important recent development is the July 2026 amendment bringing cell or stem-cell-derived products, gene therapeutics and xenografts within the Centrally License Approving Authority framework. This strengthens central regulatory oversight.

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4. Enforcement authorities and their jurisdiction

The enforcement jurisdiction generally depends on the location of importation, the regulatory status of the product and the conduct of the importer, manufacturer or distributor.

5. Enforcement mechanisms against unlawful cross-border shipments

A. Border detention

Detention is the first important enforcement mechanism.

Authorities may detain a shipment where:

The import licence is missing.

The product identity is uncertain.

The package contains undisclosed cellular material.

The certificate of analysis is unreliable.

The shipment is incorrectly declared.

The material may contain infectious agents.

The importer cannot establish lawful clinical-trial or therapeutic use.

Authorities may require additional documentation, testing, clarification or re-exportation.

B. Refusal of importation

If the regulatory defect cannot be remedied, the importing authority may refuse entry.

For example, an imported cell preparation requiring biological-product approval may be refused if the importer cannot demonstrate the necessary authorisation.

In the United States, FDA procedures expressly contemplate detention, refusal, re-exportation and destruction of violative imported HCT/Ps.

U.S. Food and Drug Administration

C. Seizure and confiscation

Seizure may be appropriate where products are imported contrary to applicable drug, customs or public-health laws.

It may involve:

Confiscation of cellular material.

Seizure of associated documentation.

Preservation of electronic shipment records.

Investigation of the importer and consignee.

Examination of related commercial transactions.

Seizure and confiscation must be distinguished: seizure is a protective or enforcement action, while final confiscation ordinarily requires the applicable legal procedure.

D. Injunctions

Courts may restrain manufacturers, clinics, distributors and importers from manufacturing, distributing or administering unlawful cell products.

Injunctions are particularly significant when a company continues distributing an unapproved product after receiving regulatory warnings.

E. Criminal prosecution

Depending on the applicable jurisdiction, criminal liability may arise from:

Knowingly importing prohibited medicinal products.

Forging import certificates.

Making false declarations to customs.

Selling adulterated or misbranded products.

Conducting unauthorised clinical trials.

Deliberately concealing serious product-safety risks.

Criminal responsibility depends on the statutory elements, evidence of the accused's conduct and the applicable mental element. Mere possession of an unapproved investigational product does not automatically establish every criminal offence.

6. Important judicial decisions and case laws

The following decisions are particularly important for understanding enforcement against unapproved cellular products. Some concern direct FDA enforcement, while others establish broader principles governing stem-cell treatment, product classification and medical accountability.

Case 1. United States v. US Stem Cell Clinic, LLC (2021)

Major US enforcement precedent

Citation: 998 F.3d 1302 (11th Cir. 2021).

Facts:

US Stem Cell Clinic extracted adipose tissue (fat tissue) from patients, processed it to obtain stromal vascular fraction (SVF), and administered the resulting material to patients for various medical conditions.

The clinic argued that its procedure qualified for exemptions from FDA regulation under the same-surgical-procedure exception and the statutory framework governing certain human cellular and tissue products.

Legal issues:

Whether the processed cellular preparation qualified for the same-surgical-procedure exception.

Whether the product qualified as a minimally regulated HCT/P.

Whether the FDA could regulate the preparation as a drug and biological product.

Whether the clinic could distribute the product without the required authorisation.

Judgment:

The Eleventh Circuit rejected the clinic's arguments and upheld the injunction against the clinic.

The court found that the product did not qualify for the claimed exceptions because the processing altered the material and its intended use did not satisfy the applicable homologous-use requirement.

Legal principles:

Cellular preparations may fall within drug and biological-product regulation.

Processing and intended use are important in determining regulatory classification.

A clinic cannot avoid regulatory obligations merely by describing its procedure as autologous treatment.

Patient-specific origin does not automatically exempt a cellular product from regulation.

Relevance to cross-border shipments:

A foreign manufacturer cannot rely simply on the argument that a product is derived from the patient's own cells. If substantial manipulation or a non-homologous therapeutic use triggers medicinal-product regulation, the product may require authorisation before importation and administration.

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Case 2. United States v. US Stem Cell Clinic, LLC – District Court proceedings (2019)

Citation: United States District Court, Southern District of Florida, 2019.

Facts:

The FDA brought enforcement proceedings against US Stem Cell Clinic and associated entities for manufacturing and distributing an adipose-derived stem-cell product without complying with federal regulatory requirements.

The government alleged violations concerning adulteration, misbranding and inadequate manufacturing controls.

Decision:

On 4 June 2019, the district court granted summary judgment to the government, finding that the defendants had violated the FDCA.

On 25 June 2019, the court entered a permanent injunction restricting the manufacture and distribution of the products until compliance with the law.

Legal significance:

This case establishes that regulators can use judicial injunctions to stop unlawful cellular-product manufacturing and distribution.

It is especially relevant where products are manufactured without adequate controls to prevent microbiological contamination.

Cross-border application:

If a foreign supplier exports contaminated or improperly manufactured cellular products into the United States, the regulatory authority may investigate the importer, manufacturer and distribution chain.

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Case 3. Yash Charitable Trust & Ors. v. Union of India & Ors. (2026)

Important Indian Supreme Court precedent

Citation: W.P. (C) No. 369 of 2022; 2026 INSC 96, decided 30 January 2026.

Facts:

The petition concerned the administration, promotion and prescription of stem-cell therapy for autism spectrum disorder (ASD).

The petitioners challenged the use of unproven stem-cell interventions outside an adequately regulated research framework.

The proceedings examined the relationship between:

Drugs and Cosmetics Act, 1940.

New Drugs and Clinical Trials Rules, 2019.

National Guidelines for Stem Cell Research, 2017.

Medical professional ethics.

Patient consent.

Scientific evidence and clinical safety.

Issues before the Supreme Court:

Whether stem-cell-derived products fall within drug regulation.

Whether unproven stem-cell interventions can be offered as routine clinical treatment.

Whether medical practitioners can administer experimental treatments without appropriate regulatory approval.

Whether patient consent alone can justify an unproven intervention.

What regulatory consequences should follow from violations.

Judgment and legal principles:

The Supreme Court made several significant findings.

First: Classification as a drug does not automatically establish that a stem-cell intervention is permissible as a clinical service.

Second: Medical practitioners must satisfy the reasonable standard of professional care. Administration of an intervention without credible scientific evidence of safety and efficacy can amount to malpractice.

Third: The Court held that stem-cell therapy for ASD outside an approved clinical trial is unethical and constitutes malpractice.

Fourth: Patient consent does not independently legalise an unproven intervention. Consent must be based on adequate information.

Fifth: The Court recognised the importance of regulatory and professional consequences for non-compliance, including action under the applicable medical-professional and clinical-establishment frameworks.

Relevance to cross-border shipment:

This judgment is particularly important for India because a foreign manufacturer's claim that a cellular product is innovative, patient-specific or scientifically promising cannot independently establish that its importation and administration are lawful.

Importers, hospitals and medical practitioners must examine the product's regulatory status and the intended clinical use.

The judgment does not itself establish a comprehensive customs regime for cellular shipments. Its importance lies in strengthening the legal controls on the therapeutic use of unapproved stem-cell products after importation.

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Case 4. Indian Medical Association v. V.P. Shantha (1995)

Citation: (1995) 6 SCC 651.

Facts:

The Supreme Court examined whether medical services fall within the consumer-protection framework.

Legal principle:

Medical services may attract consumer-protection liability, subject to the applicable statutory conditions and exceptions.

Relevance:

A hospital or medical provider importing an unapproved cellular product and administering it negligently may face legal consequences under applicable consumer-protection principles.

For example, liability may arise where the provider:

Conceals the investigational status of the product.

Makes unsupported therapeutic claims.

Fails to disclose material risks.

Uses an improperly stored cellular preparation.

Administers a product without adequate clinical justification.

The case is relevant to downstream patient protection rather than being a direct import-enforcement decision.

Case 5. Jacob Mathew v. State of Punjab (2005)

Citation: (2005) 6 SCC 1.

Facts:

The Supreme Court considered the legal standards for criminal medical negligence.

Legal principle:

Criminal liability for medical negligence requires the applicable high threshold of gross negligence or recklessness; an ordinary error of judgment is not automatically criminal.

Relevance:

Where an imported cellular product causes serious injury, the medical practitioner, importer or manufacturer cannot automatically be held criminally liable merely because the product was unsuccessful.

Investigators must establish the relevant statutory offence and the necessary elements of criminal responsibility.

This distinction is important when separating regulatory non-compliance, civil negligence and criminal misconduct.

Case 6. Stemcyte India Therapeutics Pvt. Ltd. v. Commissioner of Central Excise and Service Tax (2025)

Citation: Supreme Court of India, judgment dated 14 July 2025.

Facts:

The dispute concerned the tax treatment of services relating to stem-cell and cell-based products, including the effect of the regulatory classification of such products as drugs.

Legal significance:

The litigation illustrates the importance of determining the legal and commercial character of cellular products when applying different statutory regimes.

Relevance:

Cross-border cellular transactions may simultaneously involve customs classification, drug regulation, taxation and healthcare-service regulation.

However, this is not a direct judgment concerning seizure or refusal of an unapproved cell-product shipment.

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Case law comparison

7. Documentation requirements for cross-border shipments

Documentation is one of the most important enforcement mechanisms because cellular materials are biologically sensitive, frequently perishable and difficult to identify through ordinary customs inspection.

A shipment should ordinarily be supported by the documents required under the applicable jurisdiction and regulatory pathway.

Important: A certificate of analysis or a foreign manufacturing licence does not replace an import authorisation where the importing country's law requires one.

8. Enforcement challenges in cross-border cell-product shipments

A. Regulatory differences between countries

A product may be classified as a tissue product in one jurisdiction and as a biological drug in another.

This creates the possibility of regulatory arbitrage.

For example, a company may manufacture a cell product in a jurisdiction with relatively permissive rules and attempt to distribute it in a country requiring a full clinical-trial or marketing authorisation.

B. Misclassification at customs

Importers may describe cellular products as:

Biological research samples.

Laboratory reagents.

Human tissue donations.

Personal medical material.

Non-commercial scientific materials.

However, customs declarations must reflect the true nature and intended purpose of the goods.

Misclassification may result in detention, penalties or prosecution where the applicable legal requirements are satisfied.

C. Temperature and biological integrity

Cell products may require cryogenic storage or controlled-temperature transportation.

A failure in temperature control may cause:

Cell death.

Loss of therapeutic potency.

Contamination.

Product degradation.

Changes in biological characteristics.

Regulatory authorities may therefore investigate both product authorisation and transportation conditions.

D. Traceability difficulties

Cell products may move through several intermediaries:

Cell collection centre.

Processing laboratory.

Contract manufacturer.

International courier.

Customs clearance agent.

Importer.

Hospital.

Treating physician.

When an adverse event occurs, determining who was responsible for the product's condition becomes difficult.

E. Emergency medical shipments

A shipment intended for a seriously ill patient may create pressure on customs authorities to release it quickly.

Nevertheless, urgency does not automatically remove import requirements.

Authorities should examine whether a lawful emergency, clinical-trial or special-access pathway is available.

9. Liability of different participants in the supply chain

Cross-border enforcement does not necessarily stop with the importer. Different parties may have separate legal responsibilities.

Liability must be determined individually. A logistics company that merely transports a sealed shipment should not automatically be treated as responsible for the manufacturer's regulatory violations.

10. Investigation and enforcement procedure

An effective enforcement investigation can be divided into eight stages.

Identification of shipment

Customs authorities identify the shipment as containing human cellular material, stem cells or a cell-based medicinal product.

Document verification

Import licences, clinical-trial permissions, manufacturing authorisations and customs declarations are examined.

Product classification

Authorities determine whether the material is a tissue, HCT/P, biological drug, ATMP or investigational product.

Scientific examination

Where necessary, samples and manufacturing records are examined for identity, purity, potency and contamination.

Risk assessment

Authorities evaluate potential infection, contamination, adverse reactions and risks to recipients.

Regulatory action

The authority may detain, refuse, quarantine, recall or seize the product, subject to its legal powers.

Civil or criminal proceedings

Appropriate proceedings may be initiated against responsible manufacturers, importers or distributors.

Post-enforcement monitoring

Authorities monitor subsequent shipments, patient safety and corrective actions.

11. International cooperation and information sharing

Cross-border enforcement requires cooperation between exporting and importing countries.

Important international frameworks include:

1. World Health Organization (WHO)

WHO guidance on human cell and tissue transplantation, biological-product quality and safety supports international regulatory cooperation.

2. International Council for Harmonisation (ICH)

ICH standards, particularly those addressing quality, safety and clinical development, provide important technical benchmarks for cellular medicinal products.

3. Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PIC/S supports cooperation and harmonisation in pharmaceutical GMP inspection systems.

4. World Customs Organization (WCO)

Customs cooperation can assist in identifying suspicious shipments, improving classification and exchanging relevant enforcement information.

5. International Health Regulations (2005)

These provide an international framework for addressing public-health risks that may have cross-border implications. They do not, however, constitute a general marketing-approval or import-licensing system for cell products.

12. Important enforcement distinctions

13. Recommendations for strengthening enforcement

Several reforms can improve international control of unapproved cellular products.

A. International regulatory harmonisation

Countries should establish more consistent definitions of cell-based medicinal products, substantial manipulation, homologous use and investigational products.

B. Digital shipment verification

A secure electronic system could connect import licences, manufacturing authorisations, clinical-trial approvals and shipment identifiers.

C. Stronger supply-chain traceability

Every shipment should have reliable donor identification, processing records, storage history and recipient linkage, with appropriate privacy safeguards.

D. Risk-based customs inspection

Authorities should prioritise products involving genetic modification, extensive cell expansion, high-risk donor material and inadequate regulatory documentation.

E. Better cooperation between customs and drug regulators

Customs authorities should be able to obtain timely regulatory advice when a shipment contains specialised biological material.

F. Stronger penalties for fraudulent conduct

Knowingly concealing the therapeutic purpose of a cellular product, falsifying authorisations or distributing unsafe products should attract proportionate legal sanctions.

G. Protection of legitimate research

Enforcement systems should distinguish genuinely authorised research, clinical trials and special patient-access pathways from unauthorised commercial treatment.

14. Illustrative hypothetical case

Consider an Indian biotechnology company importing genetically modified CAR-T cells from a foreign manufacturer.

The foreign manufacturer has permission to manufacture the product in its home country, but the Indian importer has not obtained the applicable Indian import or clinical-trial authorisation.

The shipment arrives at an Indian airport.

Possible legal consequences:

Indian Customs may examine and detain the shipment under applicable customs procedures.

CDSCO may determine the regulatory classification and whether the necessary permissions exist.

The importer may be required to provide manufacturing, product-quality and clinical-trial documents.

If the shipment lacks the necessary authorisation, its import may be refused or otherwise dealt with under the applicable law.

If false declarations or other statutory violations are established, separate proceedings may follow.

If the cells have already been administered, the authorities may investigate the hospital, importer and treating practitioners according to their respective legal responsibilities.

The fact that the foreign manufacturer possesses a valid manufacturing licence does not itself establish permission to import or administer the CAR-T product in India.

15. Conclusion

Cross-border shipment of unapproved cell products is a complex intersection of pharmaceutical regulation, customs enforcement, biotechnology governance, international trade and patient protection.

The central legal principle is that approval in the exporting country does not automatically create a right to import, distribute or administer a cellular product in the importing country.

The US decision in United States v. US Stem Cell Clinic demonstrates the importance of product classification, manipulation and intended use in FDA enforcement.

The Indian Supreme Court's decision in Yash Charitable Trust v. Union of India (2026) strengthens the framework governing unproven stem-cell interventions and medical accountability.

For India, the Drugs and Cosmetics Act, 1940, New Drugs and Clinical Trials Rules, 2019, applicable import permissions and the 2026 regulatory developments provide an important framework for controlling these products.

Ultimately, effective enforcement requires three complementary objectives:

Preventing unauthorised cellular products from entering the domestic healthcare market.

Protecting patients against scientifically unproven or unsafe interventions.

Preserving lawful international scientific collaboration and legitimate access to innovative cellular therapies.

16. Primary legal materials and further reading

The following sources are particularly useful for academic research and legal citation:

Supreme Court of India – Yash Charitable Trust v. Union of India (2026).

US Court of Appeals – United States v. US Stem Cell Clinic (2021).

India – New Drugs and Clinical Trials (Amendment) Rules, 2022.

New Drugs and Clinical Trials Rules, 2019.

US Regulation – 21 CFR 1271.420, HCT/Ps offered for import.

FDA – Imported HCT/P Compliance and Enforcement Manual.

India – 2026 amendment on advanced cell and gene therapies.

Indian Ministry of Health – Stem-cell therapy regulatory advisory, September 2026.

Academic research significance: This subject is particularly relevant to biotechnology law, international pharmaceutical regulation, customs law, transnational healthcare liability, clinical-trial governance and international public-health enforcement.