International Journal For Multidisciplinary Research

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The Impact of TRIPS-Driven Data Exclusivity on Pharmaceutical Innovation in India: Balancing Patent and Public Health

Author(s) Anuritha A, Jayshree DS
Country India
Abstract The lack of data exclusivity regulations in India presents substantial issues to the pharmaceutical
sector, public health, and international trade compliance. Data exclusivity, which limits the reuse
of clinical trial data by generics manufacturers for a predetermined period of time, encourages
pharmaceutical innovation by preserving the investments of originator companies. India's present
structure allows generic manufacturers to exploit this data without the need for extra clinical
trials, which promotes affordable drug access and has helped India become a key global provider
of low-cost pharmaceuticals. However, this strategy raises questions about intellectual property
protection and compliance with the WTO's TRIPS Agreement rules. This research investigates
these ramifications via the lenses of industry, public health, and trade compliance. For the
pharmaceutical business, the lack of data exclusivity diminishes incentives for expensive R&D
investments, potentially limiting future drug development. Internationally, India's noncompliance
with data exclusivity norms affects trade ties with partners such as the United States and the
European Union, which complain that it limits market access for originator firms. Introducing
data exclusivity regulations could increase R&D investment, promote innovation, and strengthen
India's position in trade negotiations. A balanced strategy, combining data exclusivity with
measures for vital drugs and public health safeguards, would boost both innovation and access.
Keywords data exclusivity, Public health, International Trade, Strategy, Market.
Published In Volume 6, Issue 6, November-December 2024
Published On 2024-12-02
Cite This The Impact of TRIPS-Driven Data Exclusivity on Pharmaceutical Innovation in India: Balancing Patent and Public Health - Anuritha A, Jayshree DS - IJFMR Volume 6, Issue 6, November-December 2024. DOI 10.36948/ijfmr.2024.v06i06.32114
DOI https://doi.org/10.36948/ijfmr.2024.v06i06.32114
Short DOI https://doi.org/g8tgqp
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