Post-trial access to investigational drugs in India: addressing challenges in the regulatory framework

Abstract

Through the New Drugs and Clinical Trials Rules, 2019 (2019 Rules), India has developed the rules governing post-trial access (PTA) to new drugs or investigational new drugs. However, inconsistencies and interpretational challenges exist in the application of the 2019 Rules and the Indian Council of Medical Research Guidelines 2017. This conflation poses a real harm to the trial participants, specifically the ones with limited access to healthcare facilities. Since drug laws in India do not expressly deal with other forms of access like the 'Compassionate Use' or 'Expanded Access' mechanism, demarcating the scope and describing the strategies for PTA are the need of the hour. We propose possible strategies to address inadequacies in the regulatory regime and establish 'win-win' situations among all stakeholders. We further argue that India is well positioned to provide leadership by developing detailed PTA provisions and may set a potential path for the other clinical trial host countries.

Keywords: Benefit sharing; Investigational Drugs; Post-trial access; Pre-approval access; Research ethics; The New Drugs and Clinical Trials Rules.