The Indian Council of Medical Research (ICMR) has released an addendum to its 2017 National Ethical Guidelines, establishing a structured ethical framework for Research in Integrative Medicine (RIM). This initiative aims to bolster the scientific foundation of Ayush-based integrative healthcare by ensuring ethical rigor and regulatory compliance in studies combining traditional and modern medical practices.

Vaidya Rajesh Kotecha, Secretary of the Ministry of Ayush, emphasized that these guidelines encourage the scientific community to pursue Integrative Medicine research with increased credibility and confidence. He stated that the framework seeks to inspire evidence-based integration of traditional and modern medicine, ensuring safe, effective, and scientifically validated healthcare solutions.

Integrative Medicine (IM) adopts a multimodal approach, combining Ayush systems with conventional medicine to enhance patient care and health outcomes. Given the global interest in holistic and personalized medicine, ethical and regulatory clarity is crucial to uphold the credibility, safety, and efficacy of integrative approaches.

The addendum introduces several key measures:

• Ethics Committees Composition: Committees overseeing such research must now include two Ayush subject-matter experts, with at least one external to the institution, ensuring comprehensive and informed deliberations.
• Informed Consent: Standards have been enhanced to ensure participants receive clear, tailored information about Integrative Medicine interventions, adhering to India’s standard ethical guidelines for biomedical and clinical research.
• Regulatory Compliance: Ayush-approved medicines used in integrative research will not require additional safety trials or preclinical studies. However, non-codified traditional medicines must undergo the complete 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.

These guidelines are expected to guide researchers, institutions, Ethics Committees, and regulatory bodies involved in Integrative Medicine research, ensuring that scientific integrity and patient safety remain paramount.

For more details, refer to the official ICMR document.