ICMR addendum to ethical framework for IMR

The Indian Council of Medical Research (ICMR) has published an addendum to its national ethical guidelines, specifically addressing research in integrative medicine, aiming to provide a structured ethical framework for such studies and ensure scientific integrity and patient safety. Integrative medicine involves a multi modal approach where Ayush systems are integrated alongside modern/conventional medicine to enhance patient care and improve health outcomes.

The addendum aims to guide researchers, institutions, ethical committees and regulatory bodies involved in integrative medicine research (IMR). Ethical Committees overseeing integrative medicine research must include two Ayush subject-matter experts, with at least one external to the institution, ensuring well-rounded deliberations.

Ayush-approved medicines used in integrative medicine research will not require extra safety trials or preclinical studies. However; non-codified traditional medicines must undergo the full regulatory process. NCISM India has designed a course titled “Fundamentals of Integrative Medicine. NCISM electives had been introduced in Ayush curriculum to provide an opportunity to the students to get introduced, exposed and oriented  to various allied subjects required to understand and build am inter disciplinary approach.

The National Medical Commission (NMC) made it compulsory to have a “Department of Integrative Medicine Research" to promote integration of modern medicine with Ayush.
The main thrust is on the academic qualification of the two Ayush professionals to be included in the ethical committee. Postgraduate courses are available in several disciplines in Ayurveda including clinical and non-clinical.

A clinical trial in Ayurveda or more broadly Ayush is a new development.  So far experts have dumped the types of clinical trials or studies published in journals barring a few. Very rare Clinical Research Organizations are operative for the traditional drugs. Experts have warranted until standardized clinical trials are not conducted; the efficacy of the traditional drugs shall always be under scanner.

Integrative medicine research amalgamates the traditional drugs with modern medical science and this combination needs afresh clinical trials. Here it is worthwhile to stress that integrative medicine research concept has been implemented in the medical institutions and outcome of the same is eagerly awaited.
Several efforts have been carried out in the past for filling the vacuum between the practicing systems of the medicine.  

Due to ideological differences between the apex bodies the efforts have failed miserably to do something constructive. In the past, the Central Council of Indian Medicine (CCIM) issued several orders and notifications highlighting rights of Ayurvedic practitioners. Had these measures delivered any desirous results? Since CCIM has been dissolved; NCISM must issue guidelines for protecting rights of practitioners of integrative medicine.

Bringing innovative concepts and new academic disciplines in Ayush has received worldwide attention. Comparison of initiatives like integrative medicine research and Ayurvedic biology with desh ka prakriti parikahan has sparked debate among perspective students and faculty. Database on basic make up of a personality (based on the three biological humours) is of historic significance meant for compliance purpose only.

ICMR addendum to ethical framework for integrative medicine research is aimed at increasing accountability of the Indian traditional medical systems. Ethical framework for integrative medicine research needs meticulous regulations and guidelines. Practical recommendations, standardized protocols and standard operative procedures and implementation of all is critical to the development of integrative medicine.

Before the establishment of CCIM and NCISM, several government committees were constituted and majority of them emphasized the integrative medicine model. A right of a practitioner of Ayush and practitioner of integrative medicine is entirely a distinct matter. How much CCIM, NCISM and Ayush department has succeeded in nurturing rights of an Ayurveda practitioner? It must be accepted with an open mind that Ayush sciences are heavily dependent on modern medical science for survival in the future. Advocacy of using modern medical procedures by the Ayush officials is testimony to the fact.

Recognition and other regulatory issues of integrative medicine in India need to be specified. Alternative medicine is officially not recognized and several notifications have been issued by the apex bodies. Introduction of Ayurveda biology In UGC list of subjects is integration of basic principles of Ayurveda with biology.  Reverse pharmacology is integration of dravyaguna (Herbal Materia Medica & Pharmacology) with conventional pharmacology. 

The syllabus in practice in the working span of Central Council of Indian Medicine comprised of modern medical subjects besides the elements of Ayurveda.  Integration of both the systems has existed right from the beginning.  The new curriculum designed by NCISM  has a maximum element of modern medical science particularly in the clinical subjects.  Here again glimpses of integrative medicine are evident.
The foremost apprehension regarding the integrative medicine research is standardization of regulatory framework. 

Ethnomedicine, Traditional medicine, Alternative Medicine and Folk medicine are interexchangable but confusing terms.  If the framework of integrative medicine is implemented in India the nomenclature of undergraduate and postgraduate courses in Ayush shall be automatically revised. 

The practical aspect of the addendum needs to be addressed. The scope and regulation of integrative medicine in other countries needs to be analyzed. World Health Organization's policy on traditional medicine is a necessary document for the key issues and solutions.

ICMR has a dedicated division on the medicinal plants. Several monographs and compendia have been published by ICMR promoting scientific validation. ICMR Institute on traditional medicine has been established to provide scientific footing to the traditional medicine. The scientific approach towards traditional medicine and integrative medicine is not identical Traditional medicine research explores in depth studies on the fundamental principles and practices. Integrative medicine research is based on the findings of the concomitant use of two medical systems. In light of use of the two systems together; integrative medicine fully fits in the spectrum of complementary medicine.

Have these developments got impact on the career graph of Ayush degree holders?
Syllabus and curriculum of integrative medicine needs practical approach. If the integrative medicine model is implemented across India; probably a new regulatory body shall be constituted. This body shall be responsible for implementing the provisions of the central act like IMCC, 1970 or NCISM, 2020.

Integrative medicine research is a new development and advantage of implementation needs critical discussion.  Degrees like GAMS, BAMS, BHMS, DHMS, BUMS and BSMS are far away from popularity as compared to MBBS degree. A degree in integrative medicine is under process if the model is implemented in India. However; commercial viability, scientific validation and regulatory issues are worrying factors as evident in case of various Ayush degrees mentioned above.

The Indian Medical Association has begun the introduction of the proposed MBBS course (Bachelor's degree in medicine and Bachelor's degree in surgery) and the BAMS program (Bachelor's degree in Ayurvedic Medicine and Surgery). This initiative is in a conceptual stage and has a program developed by the Ministry of Health and Welfare of the Ministry of Family and Ayush.

The aim is to contribute to integrated medical practices and follow the national priorities of Indian healthcare in traditional fundamental medicine within the framework of traditional healthcare frameworks. Nevertheless, the proposal came across opposition from the Indian Medical Association. This refers to the fear of what has called it regression, demanding a retreat, potentially creating a "hybrid doctor," and affecting scientific gravity. This retrograde step must be reversed.