Bridging Two Paradigms: A Reverse-Pharmacology Framework for CTRI/ICMR-Compliant Ayurvedic Clinical Trial Design
DOI:
https://doi.org/10.52482/ayurline.v10i06.1120Abstract
Ayurvedic drug development in India occupies a regulatory space distinct from conventional new chemical entities, governed jointly by the Ministry of AYUSH, the Central Drugs Standard Control Organisation (CDSCO), and the ethical framework of the Indian Council of Medical Research (ICMR) [1-3]. Reverse pharmacology (RP) - a discovery paradigm that begins with documented clinical experience and works backward toward mechanistic validation - has been proposed as a scientifically rigorous and cost-efficient route for translating classical Ayurvedic formulations into evidence-based therapeutics [4-6]. This paper examines whether reverse pharmacology can additionally function as a regulatory bridge - that is, whether its three canonical stages (documentation, exploratory studies, confirmatory clinical research) can be explicitly mapped onto India's Clinical Trials Registry (CTRI) registration requirements, the National Ethical Guidelines for Biomedical and Health Research (ICMR, 2017), and the New Drugs and Clinical Trials Rules, 2019 (NDCT 2019) [1,2,7]. Using a narrative synthesis of the published literature and a retrospective review of CTRI registry data, we find that Ayurveda accounts for more than half (2,054/3,632; 56.6%) of all AYUSH trials registered between 2009 and 2020, yet methodological audits of these trials - including a 140-trial analysis of Ayurveda COVID-19 protocols - continue to report incomplete randomisation and blinding detail [8,9]. We propose an integrated five-checkpoint framework linking each RP stage to a specific regulatory or ethical deliverable, and illustrate its institutional application using an anonymised, in-progress pilot-protocol series for periumbilical (Nabhi-route) herbal oil formulations.
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