Abstract

COMPARARTIVE STUDIES ON DRUG DEVELOPMENT AND REGULATION ON CLINICAL TRIALS OF PEDIATRICS IN US, EU, INDIA

Keerthana N., Nuthan A., Varshini G. N., Shrish Patil, Suman Kalyan Mondal, Jesindha Beyatricks*

ABSTRACT

This study is therefore essential for guiding regulatory evolution in India, fostering safer and more effective pediatric therapies, and supporting global efforts to ensure that children are no longer therapeutic orphans. A strong, dedicated regulatory approach is crucial to protect and promote child health worldwide. Pediatric drug development presents unique challenges that differ significantly from adult clinical research. Children are not simply "small adults" - they have distinct physiological, developmental, and pharmacological characteristics that require specialized approaches to drug testing and approval. The development of pediatric medication faces numerous challenges, including a small and disorganized market, ethical and methodological restrictions for pediatric studies, large research expenses, and a constrained and unreliable data supply. These obstacles affect the quality, safety, and efficacy of pediatric dosage forms and physiologicaland formulation related challenges. Consequently, only a small amount of research has been done to tailor medicines to the needs of children. Despite the large number of children affected in affluent countries, the pediatric market remains less. Regulatory frameworks, particularly in the United States and Europe, have significantly boosted pediatric research, leading to more medicines being developed and approved for children. These regulations address the historical issue of children being treated as ―therapeutic orphans‖ because drugs were not specifically tested for them. Pharmaceutical and medical device regulation varies greatly across India, the USA, and Europe, creating both barriers and opportunities for harmonisation. Recent advances and ongoing initiatives focus on aligning approval processes, clinical protocols, and compliance, with particular need in pediatric drug development and device regulation.

Keywords: FDA, EMA, CDSCO, Padiatric, Pediatric Committee.