Integrating Real-World Evidence (RWE) in Oncology Drug Regulation: A Comparative Analysis of CDSCO and Health Canada

Cancer remains a major global health challenge, necessitating continuous innovation in oncology therapeutics. While randomized controlled trials (RCTs) are the traditional gold standard for evidence generation, they often lack applicability to diverse real-world populations. This has fuelled growing interest in incorporating Real-World Evidence (RWE), derived from Real-World Data (RWD), into regulatory decision-making processes, especially in oncology. This study aims to compare how RWE is integrated into oncology drug regulation by two key regulatory bodies, Health Canada and India’s Central Drugs Standard Control Organization (CDSCO), in order to identify lessons and opportunities that can support India's evolving regulatory framework. A qualitative comparative analysis was conducted using regulatory documents, guidance frameworks, and real-world case examples. Canada’s CanREValue initiative was explored in depth, alongside an assessment of India’s emerging digital health infrastructure and policy efforts. Health Canada has established a mature RWE framework supported by multi-stakeholder collaborations and pilot projects, facilitating dynamic regulatory decisions in oncology. In contrast, CDSCO is in the early stages of RWE adoption, with limited formal guidance. However, initiatives like the Ayushman Bharat Digital Mission (ABDM) and national health registries offer promising pathways. Canada’s regulatory progress offers valuable insights for India. Strengthening digital infrastructure, developing national RWE frameworks, and fostering collaboration could transform India’s oncology regulatory ecosystem. This study highlights the potential of RWE to improve evidence-driven decision-making and enhance access to cancer therapies.