Public Interest Litigation in Health Technology Approvals

Introduction

Public Interest Litigation (PIL) is an important constitutional mechanism through which individuals, social organisations, and public-spirited persons can seek judicial intervention to protect public health. Health technology approvals concern regulatory decisions involving medicines, vaccines, medical devices, diagnostic tools, biotechnology products, and clinical trials.

In India, such approvals are primarily governed by the Drugs and Cosmetics Act, 1940, the New Drugs and Clinical Trials Rules, 2019, and the regulatory framework administered by the Central Drugs Standard Control Organisation (CDSCO). PIL may be used where approval processes allegedly ignore safety, efficacy, informed consent, transparency, or the rights of vulnerable populations.

Under Article 32, the Supreme Court may be approached for enforcement of fundamental rights; under Article 226, High Courts may issue writs for fundamental rights and other legal purposes. Article 21, which protects life and personal liberty, provides a central constitutional basis for challenging unsafe or unlawful health technology decisions.

Scope of Judicial Review

Courts do not ordinarily replace scientific regulators or independently decide whether a medicine or device should receive approval. Regulatory decisions often require specialised scientific evaluation. However, judicial review may examine whether authorities:

followed the applicable statutory procedure;

considered relevant safety and efficacy evidence;

protected clinical-trial participants and obtained valid informed consent;

acted reasonably, transparently, and without arbitrariness;

addressed serious public health risks and conflicts of interest.

The purpose of PIL is therefore to ensure lawful and accountable regulation, rather than to substitute judicial opinion for expert scientific judgment.

Important Case Laws

1. Kalpana Mehta v. Union of India (2018) 7 SCC 1

This is a leading PIL concerning health technology approvals. The petitioners challenged the process surrounding the HPV vaccine programme involving adolescent girls in Gujarat and Andhra Pradesh. They raised concerns regarding clinical-trial safeguards, consent, regulatory approval, and alleged adverse effects.

The Supreme Court considered the constitutional role of courts in examining regulatory processes and held that Parliamentary Standing Committee reports may be considered in judicial proceedings, subject to constitutional limits. The case demonstrates that PIL can scrutinise the legality and accountability of vaccine approval and clinical-trial systems.

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2. Aruna Rodrigues v. Union of India (2012) 5 SCC 331

The petitioners challenged the environmental release of genetically modified organisms (GMOs), alleging inadequate biosafety evaluation and potential risks to human health and the environment. The Supreme Court examined the need for scientific scrutiny and regulatory safeguards before permitting GMO release.

The case illustrates how PIL can seek judicial oversight where biotechnology approvals may create risks extending beyond individual consumers to the public and environment. It also highlights the importance of expert assessment and precaution in biotechnology governance.

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3. Jacob Puliyel v. Union of India, 2022 INSC 503

The petitioner filed a PIL questioning aspects of COVID-19 vaccine policy, including disclosure of clinical-trial data, adverse-event monitoring, and vaccine mandates. The Supreme Court discussed bodily autonomy, public health, scientific evidence, and the statutory approval process.

The Court did not treat the petition as a basis to replace the expert regulatory system. Instead, it assessed the claims against the governing legal framework and the evidence presented. The case is relevant to judicial review of vaccine approvals and the balance between transparency, individual rights, and regulatory expertise.

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4. Union of India v. Pfizer Ltd., 2017 INSC 1248

The Supreme Court examined the Central Government’s power under Section 26A of the Drugs and Cosmetics Act, 1940, to regulate, restrict, or prohibit a drug in public interest. It held that the Government’s satisfaction must be based on relevant material and the statutory conditions.

Although not itself a PIL about an approval, the decision is relevant to public-interest challenges involving drug safety and regulatory action. It shows that health-related executive powers are reviewable where statutory requirements are not met.

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5. Surgical Manufacturers and Traders Association v. Union of India (Delhi High Court, 2023)

The Delhi High Court considered challenges to notifications bringing medical devices within the regulatory framework of the Drugs and Cosmetics Act, 1940. The Court emphasised the public interest in patient safety and declined to interfere with the regulatory expansion challenged in the petitions.

The case demonstrates that judicial review of health technology regulation also involves balancing public safety against the interests of manufacturers and traders.

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Conclusion

Public Interest Litigation is a significant instrument for ensuring that health technology approvals comply with constitutional and statutory standards. It enables scrutiny of clinical trials, informed consent, vaccine and drug approvals, medical-device regulation, biosafety, and post-approval monitoring.

However, courts generally respect the specialised role of scientific regulators. Judicial intervention is most appropriate where there is evidence of illegality, procedural failure, arbitrariness, inadequate safeguards, or a serious threat to fundamental rights. Thus, PIL promotes public accountability while preserving the distinction between judicial review and scientific decision-making.