Approval Trends of Recombinant DNA (r-DNA) Therapeutics in India: A Five- Year Review

Introduction: Recombinant DNA (r-DNA) technology has revolutionized modern therapeutics, enabling the large-scale production of safe, effective, and targeted biologics. India has witnessed a growing adoption of r-DNA-based therapies in diverse disease areas over the past five years. This review systematically analyzes the approval trends of r-DNA therapeutics in India between 2020 and 2024, highlights regulatory frameworks, therapeutic areas, and discusses the associated market dynamics and challenges. Approval data were obtained from the Central Drugs Standard Control Organization (CDSCO) and supplemented with information from published literature, drug databases, and industry reports. Therapeutics were categorized based on indication, origin (indigenous/imported), and product type. A total of 111 r-DNA therapeutics was approved over the five-year period, with a significant surge in 2023. Oncology constituted the leading therapeutic area (38% of total approvals), followed by diabetes, hemophilia, and osteoporosis. The majority of approvals were monoclonal antibodies and recombinant proteins. Despite the progress, a substantial portion of the products remain imported, highlighting gaps in local manufacturing. Conclusion: India is emerging as a significant player in r-DNA therapeutics. However, regulatory harmonization, indigenous development, cost containment, and infrastructure strengthening are essential to realize the full potential of r-DNA technology in improving public health outcomes.