The Indian Council of Medical Research (ICMR) has published an addendum to its National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), establishing a structured ethical framework for Research in Integrative Medicine (RIM). The Ministry of AYUSH issued a press release on this development on March 5, 2025.
Ethical Rigor for Integrative Medicine
The addendum provides clear ethical guidelines for research that combines traditional Ayush systems with modern medical practices, ensuring ethical rigor and regulatory compliance.
The Secretary, Ministry of Ayush, emphasized the importance of these guidelines, 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. By providing a structured ethical framework, we aim to inspire researchers to advance evidence-based integration of traditional and modern medicine, ensuring safe, effective, and scientifically validated healthcare solutions for all.”
Integrative Medicine (IM) involves a multimodal approach, integrating Ayush systems with modern medicine to enhance patient care. With increasing global interest in holistic and personalized medicine, the ICMR has recognized the need for ethical and regulatory clarity to ensure the credibility, safety, and efficacy of integrative approaches.
Key Features of the Addendum
The addendum provides guidance for researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in IM research, prioritizing scientific integrity and patient safety.
Ethics Committees overseeing IM research must include two Ayush subject-matter experts, with at least one external to the institution, ensuring well-rounded deliberations.
Informed consent standards have been strengthened, requiring clear and tailored information about IM interventions for research participants.
Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies. However, non-codified traditional medicines must undergo the full regulatory approval process.
All research must align with the Drugs & Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.
The ICMR’s initiative aims to promote evidence-based integration of traditional and modern medicine, fostering a robust scientific foundation for Ayush practices. By ensuring ethical rigor and regulatory compliance, the addendum will enhance the credibility and acceptance of integrative medicine research.
