The Indian Council of Medical Research (ICMR) has released new guidelines to establish a formalized ethical structure for Research in Integrative Medicine (RIM). These guidelines have been released as an addendum to the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), which aim to enhance the scientific rationale of Ayush-based integrative healthcare by ensuring stringent ethical norms and regulatory compliance in studies that integrate traditional medicine with modern medical practice.
One major aspect of the new regulations is that medicines approved by Ayush, used in integrative research, will not need to go through additional safety trials or preclinical work. But non-codified traditional medicine needs to go through the entire regulatory approval process prior to use. The addendum further requires that all studies have to follow the Drugs & Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines applicable to the Ayush system.
To uphold ethical integrity, Ethics Committees overseeing such research must now include two Ayush subject-matter experts, with at least one being external to the institution. Further, more stringent informed consent procedures have been implemented to make sure that research participants are provided with complete, clear information about Integrative Medicine interventions according to India's ethical guidelines for biomedical and clinical research.
Dr. Shelja Chauhan, BAMS, PGDCR, shared her opinion with MedBound Times regarding the decision made by ICMR, saying, "Ayurvedic medicines have a long history of safe use, but their interaction with modern treatments still needs careful study. Instead of exempting them from extra safety tests, it’s wise to use traditional knowledge with additional research when necessary."
Integrative Medicine (IM) follows a multimodal treatment strategy, integrating Ayush systems with mainstream medical interventions to enhance patient care and health outcomes. As the world becomes increasingly interested in holistic and personalized healthcare, it is important to have ethical and regulatory clarity to ensure safety, credibility, and efficacy of integrative medical practices.
Highlighting the importance of these updates, Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, observed that these ethical guidelines are a significant step towards bringing credibility and trust within the scientific fraternity. According to him, "By giving a formal ethical framework, we want to encourage researchers to develop evidence-based integration of modern and traditional medicine so that safe, efficient, and scientifically proven healthcare solutions could be made available to everyone."
(Input from various sources)
(Rehash/Sai Sindhuja K/MSM)
