Regulatory Reliance on Foreign Approvals

Introduction

Regulatory reliance on foreign approvals is a mechanism through which a national regulatory authority uses the assessment, inspection findings, or marketing authorisation decisions of a trusted foreign regulator to inform its own decision. In biotechnology, this may apply to vaccines, biologics, biosimilars, gene therapies, and other medicinal products.

Reliance can reduce duplication, improve regulatory efficiency, and accelerate access to medicines. However, it does not necessarily mean that a foreign approval is automatically valid domestically. The receiving regulator must consider local law, public-health priorities, population-specific risks, and the reliability of the foreign assessment.

The World Health Organization (WHO) describes regulatory reliance as a process in which a regulator gives significant weight to the work of another regulator or trusted institution while retaining responsibility for its own decisions. Reliance differs from full recognition, where a country accepts another authority’s decision under an applicable legal arrangement.

Legal Framework in India

India permits regulatory consideration of foreign approval and foreign-generated evidence, but the decision remains governed by Indian law. Under the New Drugs and Clinical Trials Rules, 2019, CDSCO considers applications for import, manufacture, and marketing of new drugs, including products already approved abroad. Foreign approval status and safety and efficacy data may inform the review, but do not necessarily replace domestic requirements.

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For biological products, CDSCO guidance also provides for a case-by-case expedited reliance pathway in specified circumstances, including priority diseases, serious or life-threatening conditions with unmet medical needs, public-health emergencies, and orphan products. The authority evaluates the foreign regulator’s decision and supporting assessment report before deciding whether to expedite the Indian review.

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The key distinction is:

Reliance: foreign assessment informs the domestic decision.

Recognition: a foreign decision is accepted under a formal legal arrangement.

Automatic approval: the product receives domestic authorisation solely because it was approved abroad. This is not the general Indian rule.

Foreign approval may be highly persuasive evidence, but CDSCO retains responsibility for the domestic authorisation.

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Important Case Laws

1. Jacob Puliyel v. Union of India, 2022 SCC OnLine SC 533

The Supreme Court considered issues concerning COVID-19 vaccine approvals, safety data, and transparency. It examined the regulatory process followed by CDSCO and the role of the Subject Expert Committee. The judgment is relevant because it emphasises that domestic vaccine decisions must be assessed within India’s statutory framework and supported by appropriate scientific evaluation. Foreign regulatory decisions may be informative, but they do not displace India’s own regulatory responsibilities.

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2. Union of India v. Pfizer Ltd., (2018) 2 SCC 39

The Supreme Court considered the Central Government’s power under Section 26A of the Drugs and Cosmetics Act, 1940, to regulate or prohibit drugs in the public interest. It held that the power must be exercised on relevant material and in accordance with the statutory framework. The decision supports the principle that regulatory authority must make its own legally authorised decision rather than treating another authority’s assessment as automatically determinative.

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3. Bayer Corporation v. Union of India, 2019 SCC OnLine Del 8209

The Delhi High Court distinguished patent law from the regulatory framework for drug approvals. It considered the use of foreign clinical and regulatory information in drug development and emphasised that regulatory requirements are governed by the Drugs and Cosmetics legislation, whereas patent rights are governed by a separate statutory framework. The decision illustrates that foreign data may be relevant to regulatory purposes, but its use does not itself establish domestic marketing authorisation.

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These decisions are relevant to the principles underlying regulatory reliance. There is no general Indian judicial rule that makes foreign marketing approval automatically binding on CDSCO.

Conclusion

Regulatory reliance on foreign approvals can improve efficiency, reduce duplicated assessments, and accelerate access to biotechnology products. Its legitimacy depends on the reliability of the foreign assessment, the comparability of the product and manufacturing conditions, and compliance with domestic law.

The governing principle is reliance without surrender of regulatory responsibility. Foreign approvals and scientific assessments may inform the decision, but the Indian regulator remains accountable for ensuring that the product meets applicable domestic safety, efficacy, and quality requirements.