The Indian Council of Medical Research (ICMR) has released an addendum to its National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017), which offers a systematic ethical framework for Research in Integrative Medicine (RIM). The move is expected to enhance credibility and confidence in scientific research that combines Ayush-based and conventional medicine.

Significance of the Initiative:

• Promotes evidence-based research in Integrative Medicine (IM).

• Provides ethical and regulatory clarity to scientific studies involving traditional and modern medical practices.

• Enhances India's global leadership in holistic and personalized medicine.

Key Provisions in the Addendum:
Ethics Committees Should Have Ayush Experts:
All Ethics Committees (EC) to be appointed to oversee RIM studies should comprise two Ayush subject-matter experts, out of which at least one shall be external to the institution.

Improved Informed Consent Standards

• Participants in research should be provided with explicit, individualized information regarding Integrative Medicine interventions.

• Compliant with India's standard ethical protocols for biomedical and clinical research.

Regulatory Transparency for Ayush Medicines in Research:

• Ayush-approved drugs need not have extra safety trials or preclinical tests.

• Non-codified traditional drugs should go through full regulatory approval procedures.

Compliance with Mandatory Healthcare Laws:
Research should be in compliance with the following:

• Drugs & Cosmetics Act (1940)

• New Drugs & Clinical Trial Rules (2019)

• Good Clinical Practice (GCP) guidelines for Ayush systems

Official Statement:
Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush:
"The inclusion of these ethical guidelines is an important step towards motivating the scientific community to delve into Integrative Medicine with more credibility and confidence.
We want to encourage researchers to develop evidence-based integration of modern and traditional medicine in a manner that makes available safe, effective, and science-backed healthcare solutions for everyone."

Why This Matters:

• Fosters interaction between contemporary and traditional health systems.

• Favors international uptake of Indian Integrative Medicine practices.

• Guarantees patient safety and scientific integrity in RIM research.

As interest in integrative healthcare picks up, ICMR's ethical framework will become the key to establishing Integrative Medicine. Through ethical and regulatory compliance, this initiative will promote Ayush-based research towards scientifically-validated, patient-care-oriented care.