New Guidelines on Integrative Medicine Research: Ayush-Approved Medicines Exempt from Extra Trials
New Delhi (The Uttam Hindu): The Indian Council of Medical Research (ICMR) has introduced new guidelines for research involving Integrative Medicine (IM), offering clarity on regulatory processes for Ayush-approved and traditional medicines. According to the updated guidelines, Ayush-approved medicines used in integrative research will not require additional safety trials or preclinical studies. However, non-codified traditional medicines will still need to undergo the entire regulatory approval process.
The ICMR published this addendum to its National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) on Wednesday, providing a structured ethical framework for research in Integrative Medicine (RIM). The new guidelines aim to strengthen the scientific basis for Ayush-based integrative healthcare, ensuring regulatory compliance and ethical rigor in research exploring the integration of traditional and modern medical practices.
The guidelines stipulate that Ethics Committees overseeing such research must include two Ayush subject-matter experts, with at least one being external to the institution. This ensures a well-rounded and informed deliberation process. Additionally, informed consent standards have been strengthened, requiring research participants to receive clear and tailored information about Integrative Medicine interventions while adhering to India's standard ethical guidelines for biomedical and clinical research. All research must align with the Drugs and Cosmetics Act (1940), New Drugs & Clinical Trial Rules (2019), and Good Clinical Practice (GCP) guidelines specific to Ayush systems.
Integrative Medicine involves a multimodal approach, combining Ayush systems with modern medicine to enhance patient care and improve health outcomes. With increasing global interest in holistic and personalized medicine, the need for ethical and regulatory clarity has become crucial to ensure the credibility, safety, and efficacy of integrative approaches.
"This addendum aims to guide researchers, institutions, Ethics Committees (ECs), and regulatory bodies involved in Integrative Medicine research, ensuring that scientific integrity and patient safety remain paramount," the Ministry of Ayush stated.
Vaidya Rajesh Kotecha, Secretary of the Ministry of Ayush, emphasized the significance of the new guidelines. "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."
As this development unfolds, the future of Integrative Medicine research in India looks promising, with a stronger focus on safety, ethics, and scientific integrity.
