India’s lack of Regulatory Data Protection (RDP) reduces incentives for biopharma R&D and clinical trials contributing to delayed access to innovative medicines. Global evidence presented in the paper links RDP with greater medicine availability, higher clinical trial activity, and increased R&D investment, without a discernible impact on public healthcare expenditure. A time-bound statutory RDP framework could therefore strengthen India’s innovation ecosystem, attract investment, and accelerate patient access to breakthrough therapies without extending patent protection.