PHARMANEST : AN INTERNATIONAL JOURNAL OF ADVANCES IN PHARMACEUTICAL SCIENCES - Volume 4, Issue 6, November - December 2013

Pages: 1675-1686

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CURRENT SCENARIO AND REGULATORY FRAMEWORK OF PAEDIATRIC DRUGS IN THE UNITED STATES (US) AND EUROPE WITH A BRIEF PERSPECTIVE TO INDIA

Author: SARASWATHI DEEPTHI, SUDEEP M, SUDHEER MOORKOTH*

Category: Pharmaceutical Sciences

Abstract:

Since from decades, healthcare professionals were unable to provide suitable information for prescribing medicines for the treatment ofpaediatric population. Many depended on off-labeled drugs by manipulating the adult dosage form, simply by crushing the tablets or diluting the syrups. Even though there iseminent differences between children and adults, most of the drugs that have been developed for adults are simply used for children without necessary studies. This kind of practice is therapeutically successful for the drugs which have a wide therapeutic window and thus are relatively safe.There exist some barriers in developing paediatric drugs. Major regulated nations have identified these barriers and have developed specific regulations that will enhance the paediatric drug development. This includes the Best Pharmaceuticals for Children‟s Act (BPCA), Paediatric Research Equity Act (PREA) of the United States and the Paediatric Investigation Plan (PIP) of Europe. This article highlights the global situation of paediatric medicines and their regulations in Europe and United States (US) with a brief perspective to India.

Keywords: Paediatric drugs, Regulatory framework, United States, Europe, India