ItemArticle

Regulatory data protection for global economy of biopharmaceuticals: comparative legal analysis with focus on innovative biopharma in India

Title
Regulatory data protection for global economy of biopharmaceuticals: comparative legal analysis with focus on innovative biopharma in India
Creator
Monisha, B.; Valarmathi, R.
Description
This provides a new global economy of biopharmaceuticals with an exclusive right over clinical data, meaning that no other person or persons may use them for a specified period. This study, therefore, offers a critical analysis of complementary protection granted to biopharmaceuticals by patents and regulatory data protection (RDP) globally with respect to innovation, competition, and access to medicines. This study probes the effectiveness and the challenge RDP is making using statistical analysis, financial modelling, and comparative analysis of the regulatory framework in Central Drugs Standard Control Organization (CDSCO), Food and Drug Administration (FDA), and Emergency Market Authorization (EMA). The justification for this combination is that RDP fosters innovation due to the protection of clinical trial investments, which provides a drive for the introduction of innovative biologics but does not inhibit the launch of biosimilars. With RDP, though they are very different in what they do, patents have created an enabling environment to make sustainable innovation in biopharmaceuticals accessible. International regulatory hurdles have to emerge so that a balance that advances both innovation and affordability becomes the norm within biopharma. Copyright 2025 Inderscience Enterprises Ltd.
Source
International Journal of Trade and Global Markets;Volume;21;Issue;3;pp.319-353
Date
01-01-2025
Publisher
Inderscience Publishers
Subject
access to medicine; clinical trial investments; global economy of biopharmaceuticals; patent law; RDP; regulatory data protection; sustainable development goal
Coverage
Monisha B., School of Law, Christ (Deemed to be University), Karnataka, Bengaluru, 560029, India; Valarmathi R., School of Law, Christ (Deemed to be University), Karnataka, Bengaluru, 560029, India
Rights
Restricted Access; Hardcopy may be available in the library
Relation
ISSN: 17427541;
Format
online
Language
English
Type
Article

Citation

Monisha, B.; Valarmathi, R., “Regulatory data protection for global economy of biopharmaceuticals: comparative legal analysis with focus on innovative biopharma in India,” CHRIST (Deemed To Be University) Institutional Repository, accessed June 18, 2026, https://archives.christuniversity.in/items/show/23320.

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