Regulatory Requirements for Paediatric Oncology Drugs As Per CDSCO In India Comparison with United States

Paediatric oncology requires regulatory approaches that balance timely access with child-specific safety. This abstract equates the laws and rules for medicines used to treat childhood cancers in the India and United states. It reviews the regulations created by the Food and Drug Administration (FDA) in the US and the Central Drugs Standard Control Organization (CDSCO) in India focusing on trial design, approval pathways, incentives, ethics, and post-marketing safety. Paediatric oncology is a medical field that deals with diagnosing and treating cancers in children, from babies to teenagers. Children's medicine is different from adult medicine in various ways, such as how medicines are administrated, how metabolism takes place in children body and the way the body functions.  Many medicines given to children are made for adults, so the doses need to be changed to be safe for them. The USA demonstrates structured paediatric mandates (PREA, BPCA, RACE Act) and robust post-marketing mechanisms, while India operates through NDCTR 2019 and ethics-based oversight with fewer formal incentives. Differences exist in trial networks, orphan incentives, and pharmacovigilance capacity.  The article looks at the current state of laws for children's medicines worldwide to show important efforts, difficulties, and progress in this area. These regulations require that medicines are drugged properly for a child's age, tested well in clinical trials, and labelled clearly to avoid misuse. Harmonization, strengthened paediatric trial infrastructure, and targeted incentives in India could accelerate paediatric oncology drug availability while maintaining safety. Cross-border collaboration is recommended. Keywords; Regulatory requirements, Paediatric Oncology, CDSCO, FDA, Pharmacovigilance