Current Edition

Regulation for Paediatric Drug Development in India: Need of the Hour

India is a popular location for clinical research due to the multitude of benefits it offers, including a large patient pool, low costs and ethical flexibility. However, this ethical flexibility has been abused. Per se, there are no specific requirements for the conduct of clinical trials on the paediatric population, resulting in the irrational use of drugs and untoward drug reactions. With the proposed revamping of drug development guidelines in India, Dr M. V. P. Venkatesh of JSS College of Pharmacy and his associates discuss the need to introduce specific guidelines to regulate and protect the paediatric population.