The paper examines how the current absence of a statutory Regulatory Data Protection (RDP) framework in India is associated with weaker incentives for biopharma R&D and clinical trial activity, and may contribute to delayed access to innovative medicines.

Global evidence analysed in the paper indicates that markets with RDP frameworks are associated with greater availability of innovative medicines, higher clinical trial activity, and increased R&D investment, without a measurable impact on overall public health budgets.

Against this backdrop, the paper considers how a time-bound statutory RDP framework could support India’s innovation ecosystem, attract investment, and facilitate earlier patient access to innovative therapies, while remaining distinct from patent protection.