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 The Indian Council of Medical Research (ICMR)’s ethical guidelines for research in integrative medicine are a significant step in strengthening India’s clinical trials landscape, particularly in the domain of traditional medicine.
With India being a global leader in Ayurveda, Yoga, Unani, Siddha, and Homoeopathy (Ayush), these guidelines ensure that research involving traditional and modern medicine adheres to rigorous ethical and scientific standards, stated industry experts who did not want to be named.
These developments mark a significant milestone in India’s efforts to bridge traditional medicine with modern healthcare, reinforcing its global leadership in integrative medicine research, they added.
The guidelines are strengthened with inclusion of two subject experts. These professionals are from the relevant Ayush or traditional systems in the Ethics Committee (EC).
The council which issued an Addendum in its document on Research in Integrative Medicine (RIM) refers to involving multimodal interventions, wherein one or more Ayush practices are integrated alongside those of modern or conventional medicine to address the health needs of individuals.
The ethical guidelines for biomedical and health research involving human participants, facilitate research in integrative medicine. It firstly recommends inviting two subject matter experts to the EC from the relevant Ayush systems. These experts need not be permanent members of the EC but may be co-opted when there are integrative medicine research proposals under review. They will be considered part of the EC quorum for decision-making. Like other expert members of the EC, these experts should not have any conflict of interest related to the study under consideration. Additionally, at least one of these experts must be external to the institution.
The EC should be duly registered with the Department of Health Research (DHR) and may also be registered with the Central Drugs Standard Control Organization (CDSCO) if it reviews clinical trials as defined under the Drugs & Cosmetics Act, the New Drugs & Clinical Trial Rules, 2019 or other relevant regulations. For multicentre research, a common ethics review may be conducted by the designated EC.
The second aspect of the guidelines is that informed consent should be tailored to ensure that participants fully understand the nature of the research in integrative medicine. All relevant ethical considerations and guidelines for biomedical and clinical research involving humans in India shall also apply to integrative research.
Thirdly, if the medicinal product or modalities approved for use in clinical trials of Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa, Homoeopathy will not require additional evidence of safety from animal studies or phase I/II human clinical trials. Instead the research involving non-codified traditional medicines must go through the entire prescribed regulatory approval processes as per applicable guidelines and any amendments.
The experts on condition of anonymity noted that even as the ethical guidelines for research in integrative medicine is long overdue and a step in the right direction, it still treats Ayush systems physicians as secondary members to be co-opted as members of EC.
In fact the Ayush industry had long suggested that the ethics committee members should be given same status with experts and other members from other systems of medicine which is perhaps seen to be a distant dream. However this step should help get EC approvals for clinical trials and research of Ayush products on human subjects. Sooner it is seen on ground better it will be, said the industry experts.
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