Abstract

Experiment on human for the purpose of finding new treatment of the emerging ailments is a continuous process. The regulatory bodies regulate all activities related to human experimentation. Due to increase in research activities now-a-days, it is not always possible to maintain the equal focus for all the activities through the central regulatory agency. In order to maintain the stringency, regional Institutional Ethics Committee (IEC) upholds the task of regulating human experiments in India. To maximize regulatory oversight over the regional IEC and clinical trials in India, Central Drugs Standard Control Organization (CDSCO) has recently made an amendment to its regulatory guideline (Schedule Y of the Drug and Cosmetic Act). This amendment mandates the registration of Ethics Committees which will help in the accountability of the clinical trials approved or reviewed by the IEC. Such an important step in the Indian regulatory will make a great impact on the Indian clinical research scenario.

Keywords: CDSCO, ethics committee, licensing authorities, registration, schedule-Y, serious adverse events.

Graphical Abstract