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.
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