Ayush-approved medicines exempt from extra safety trials in research: ICMR

With growing global interest in holistic and personalised medicine, it is observed that ethical and regulatory clarity is essential to ensure the credibility and efficacy of integrative approaches

Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies but non-codified traditional medicines must undergo the entire regulatory approval process, according to a new set of guidelines issued by the Indian Council of Medical Research. 

The ICMR announced the changes on Wednesday as it published an addendum to its National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) to provide a structured ethical framework for Research in Integrative Medicine (RIM). 

It said the addendum aimed at strengthening the scientific foundation of Ayush-based integrative healthcare by ensuring ethical rigour and regulatory compliance in research that explores integration of traditional and modern medical practices. 

 

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 and informed deliberations, according to the new guidelines. 

Informed consent standards have been strengthened, requiring that research participants receive clear, tailored information about Integrative Medicine interventions while adhering to India's standard ethical guidelines for biomedical and clinical research, it said. 

To ensure compliance, 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, it added. 

Integrative Medicine (IM) involves a multimodal approach, where Ayush systems are integrated alongside modern/conventional medicine to enhance patient care and improve health outcomes. 

With growing global interest in holistic and personalised medicine, it is observed that ethical and regulatory clarity is essential 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 Ayush ministry said in a statement. 

Secretary, Ministry of Ayush, Vaidya Rajesh Kotecha highlighted the significance of the development. "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".