On 19^th March 2019, the Ministry of Health and Family Welfare (MoHFW) released the New Drugs and Clinical Trial Rules, 2019, which are effective from the date of publication (the only exception is Chapter IV – Ethics Committee for Biomedical and Health Research – this will come into force 180 after the publication date). The Clinical Trials Toolkit for India has been updated to reflect the New Drugs and Clinical Trial Rules, 2019.