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

Nidhi Mehrotra and Padmavati Manchikanti

Medical Law Review, 2024, vol. 32, issue 1, 20-41

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 (search for similar items in EconPapers)
Date: 2024
References: Add references at CitEc
Citations:

Downloads: (external link)
http://hdl.handle.net/10.1093/medlaw/fwad028 (application/pdf)
Access to full text is restricted to subscribers.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:oup:medlaw:v:32:y:2024:i:1:p:20-41.

Access Statistics for this article

Medical Law Review is currently edited by Professor Sara Fovargue and Professor Jose Miola

More articles in Medical Law Review from Oxford University Press
Bibliographic data for series maintained by Oxford University Press ().