REGULATORY REQUIREMENTS FOR PAEDIATRIC ONCOLOGY DRUGS AS PER CDSCO IN INDIA COMPARISION WITH JAPAN

Ashok Kumar P.*, Bhavana M. S., Chaitra S. H., Keerthana H. C., Nirupama T. S., Vathsala Vishwakarma S.

ABSTRACT

This study examines the regulatory requirements for paediatric oncology drugs in Japan and India are compared in this abstract. It draws attention to the frameworks set up by the Ministry of Health, Labour and Welfare (MHLW) and India's Central Drugs Standard Control Organization (CDSCO). The paediatric population differs from adults in several ways, including physiological factors, pharmacokinetics, pharmacodynamics, and dosage administration. However, many medications prescribed for children are formulated for adults, necessitating dose adjustments throughout childhood. This underscores the need for paediatric drug formulations and regulations worldwide. This research delves into the intricate landscape of international paediatric drug regulations to elucidate key initiatives, challenges, and advancements shaping this field. Commencing with a historical backdrop, the review outlines the evolution of regulatory frameworks across major regions, including the Japan, Europe, and other international regulatory frameworks, while underscoring the imperative for the implementation of paediatric drug regulations in India. Regulations mandate age-appropriate dosing, rigorous clinical trials, and thorough labelling to prevent misuse. While both the nations strive to enhance outcomes for children with cancer, their approaches, particularly concerning regulatory frameworks, incentives for pharmaceutical innovation and mechanisms for ensuring patient access, exhibit significant differences.

Keywords: Paediatric Oncology Drugs; Regulatory Requirements; Japan; India; MHLW; CDSCO.