• intent@hq.icmr.org.in

Dr. Dilip Raja

Dr. Dilip Raja is currently serving as Scientist-C in the Clinical Studies and Trials Unit (INTENT), Division of Development Research, at the Indian Council of Medical Research (ICMR) Headquarters, New Delhi. He holds Bachelor’s and Master’s degrees in Pharmaceutical Sciences with a specialization in Pharmacology, and a PhD from Acharya Nagarjuna University. His doctoral research focused on evaluating the protective effects of probiotic strains against statin-induced rhabdomyolysis in hypercholesterolemic rats. Dr. Raja began his professional career as an Assistant Professor before transitioning to regulatory science at the Central Drugs Standard Control Organisation (CDSCO). During his tenure at CDSCO, he conducted detailed evaluations of Serious Adverse Events in clinical trials, coordinated regulatory compensation under the New Drugs and Clinical Trials Rules (NDCTR 2019), and supported Subject Expert Committee (SEC) reviews contributing to the strengthening of India’s clinical trial governance ecosystem. He joined ICMR in 2020 as Project Manager (Project Research Scientist-II), where he played a key role in a landmark Phase III tuberculosis vaccine trial enrolling 12,000 healthy household contacts. His work encompassed trial monitoring, stakeholder coordination, regulatory documentation, CRO management, site performance oversight, and ensuring adherence to protocol and GCP requirements. From 2021, Dr Raja has served as Project Coordinator (Project Research Scientist-III) for a UKRI–MRC–funded Phase III neonatal probiotic trial involving 6,144 low-birth-weight infants. He has led critical trial components, including site readiness assessments, oversight of the investigational product supply chain, SAE management, DSMB/TSC coordination, SOP development, investigator training, and overall operational and regulatory management. Dr. Raja has contributed to several peer-reviewed publications in reputed journals, including BMJ Open, Trials, and Indian Pediatrics. His work reflects a strong commitment to advancing clinical research and public health in India.