The Indian Council of Medical Research (ICMR) has introduced an addendum to the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) to establish a structured ethical framework for Research in Integrative Medicine (RIM). This significant development aims to enhance the scientific basis of Ayush-based integrative healthcare by ensuring ethical rigor and regulatory compliance in research combining traditional and modern medical practices.

Vaidya Rajesh Kotecha, Secretary of the Ministry of Ayush, emphasized the importance of this initiative, stating, “The addition of these ethical guidelines marks a significant step in encouraging the scientific community to explore Integrative Medicine with greater credibility and confidence.” The guidelines aim to foster evidence-based integration of traditional and modern medicine, ensuring safe and effective healthcare solutions.

Integrative Medicine (IM) integrates Ayush systems with modern medicine to improve patient care and health outcomes. Given the global interest in holistic and personalized medicine, it is crucial to establish ethical and regulatory clarity to maintain credibility and patient safety in these approaches.

The addendum provides crucial guidance for researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in Integrative Medicine research. A key change is the requirement for Ethics Committees to include two Ayush experts, at least one external to the institution, to ensure informed deliberations. Additionally, the informed consent process has been strengthened to ensure participants are fully aware of Integrative Medicine interventions.

Ayush-approved medicines used in research will not need additional safety trials, but non-codified traditional medicines must undergo the full regulatory process. All research must adhere to the Drugs & Cosmetics Act (1940), the New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.

Link to the guidelines document:

https://www.icmr.gov.in/icmrobject/uploads/Guidelines/1740984016_icmraddendumethicalrequirementsforresearchinintegrativemedicine.pdf

Source/PIB