ROLE OF REGULATORY BODIES IN PEDIATRIC PRODUCTS AND PEDIATRIC DRUG EXCLUSIVITY WITH SPECIAL REFRENCE TO US, EUROPE AND JAPAN

In the present scenario, children’s are considered as small adults during administrating medication to them. The dose for children are usually given by crushing tablets, breaking tablets into halves and quarters, opening capsules, or for liquids, by proportionally reducing volume. More than 60% of all medicines used for children have never been tested and even lack authorization in the pediatric population. Several barriers may be encountered while working for the development of formulation for the pediatric population. The challenges include ethical issues, monetary concerns, type of formulation preparation, dosing, bioavailability and drug response measuring techniques. Due to diversity of children in different age groups, the consent, ethical implication and selection process, clinical studies in children differs from studies in adults. So as to obtain as much information as possible from data derived from trials in children, the modeling and simulation method is good option to support pediatric study design. The model based development of pediatric drug helps by aiming at efficiency. To encourage pharmaceutical sponsors to carry out clinical studies in the development of pediatric indications for drugs and biologics, Congress and United States Food and Drug Administration have granted perk of marketing exclusivity. India needs a pediatric legislation which should be built of a strong framework for pediatric drug development. There is a need to set a pediatric research committee which would lay down standard regulation for the pediatric drug development. Market exclusivity will encourage the sponsors to develop the pediatric specific drugs which would be safe and efficient.