New Guidelines Streamline Integrative Medicine Research, Strengthen Ethical Standards
New Delhi: The Indian Council of Medical Research (ICMR) has announced that Ayush-approved medicines used in Integrative Medicine (IM) research will no longer require additional safety trials or preclinical studies. However, non-codified traditional medicines must still undergo full regulatory approval, according to the latest guidelines.
The changes were introduced on Wednesday through an addendum to the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), providing a structured ethical framework for Research in Integrative Medicine (RIM).
Strengthening Scientific and Ethical Rigor in Integrative Medicine
The ICMR’s addendum aims to enhance the scientific foundation of Ayush-based integrative healthcare by ensuring ethical rigor and regulatory compliance in research that combines traditional and modern medical practices.
Key highlights of the new guidelines include:
✅ No Additional Safety Trials for Ayush-Approved Medicines: Integrative research using already approved Ayush medicines is exempt from extra safety testing.
✅ Full Regulatory Process for Non-Codified Traditional Medicines: Any non-standardized or non-recognized traditional medicines must still undergo the complete approval process before being used in research.
✅ Mandatory Ayush Experts in Ethics Committees: Ethics Committees overseeing such research must now include two Ayush subject-matter experts, with at least one being external to the institution, ensuring well-rounded deliberations.
✅ Stronger Informed Consent Requirements: Research participants must receive clear, tailored information about Integrative Medicine interventions, in line with India’s standard ethical guidelines for biomedical and clinical research.
✅ Alignment with Regulatory Laws: All research must comply with the Drugs and Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.
Growing Interest in Holistic Healthcare
Integrative Medicine (IM) takes a multimodal approach, combining Ayush (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) with modern medical practices to improve patient care. With the global rise in demand for holistic and personalized medicine, ethical and regulatory clarity is essential to ensure credibility, safety, and efficacy.
Government’s Commitment to Evidence-Based Integration
Commenting on the development, Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, emphasized the significance of the ethical framework:
“This 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 advance evidence-based integration of traditional and modern medicine, ensuring safe, effective, and scientifically validated healthcare solutions for all.”
The new guidelines are expected to facilitate research, enhance patient safety, and boost scientific validation of Ayush-based integrative treatments.
