Scientists studying AYUSH drugs must involve domain expert, advisory says

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An April 2 advisory issued by the AYUSH Ministry makes it mandatory for any non-AYUSH scientists undertaking research on AYUSH drugs or treatment to involve an AYUSH expert. The provocation for the advisory is publication of papers on AYUSH drugs and treatments by non-AYUSH scientists with unfounded statements and conclusions damaging the credibility and sanctity of the whole system.

An anti-diabetic Ayurvedic drug (BGR-34) developed jointly by the National Botanical Research Institute and the Central Institute for Medicinal and Aromatic Plants was launched with much fanfare in October 2016 by Prime Minister Narendra Modi. However, till date, there is no data on its safety and efficacy. No paper has been published in any scientific journal either. It is not known if a Phase III human clinical trial has been conducted prior to the launch of the drug.

But on April 2, 2019, the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) had issued an advisory asking all non-AYUSH researchers and institutions to “involve appropriate expert/institution/research council of AYUSH” while carrying out any “scientific study, clinical trial or intervention” using AYUSH drug or treatment. The involvement of AYUSH experts is also needed for “vetting of the publication” [that arises from the research] for its “outcomes and findings”.

Though the note is an advisory to researchers working in modern medicine, it concludes by saying that they “are urged to take note of the advisory for compliance” thus making it mandatory to involve an expert for carrying out research on AYUSH systems of medicine.

The advisory has been issued in order to “protect [the] public image of AYUSH” and to “prevent incorrect, arbitrary and ambiguous statements and conclusions about AYUSH”. Interestingly, the advisory is also meant for editors of medical and scientific journals. It is not clear how the ministry would be able to enforce this on editors, particularly editors of international journals.

According to the advisory, research papers and scientific studies on AYUSH drugs and treatments have been “published by non-AYUSH scientists/researchers with unfounded statements and conclusions to damage the credibility and sanctity of the whole system”. It says that such studies have been carried out by non-AYUSH researchers without involving qualified AYUSH experts.

It further adds: “Arbitrary statements and unfounded conclusions in the scientific studies and research publications related to AYUSH” cannot be allowed to jeopardise the potential and scope of AYUSH in public healthcare and distract or dissuade people from resorting to AYUSH.

Voice of dissent

“I am quite disturbed by this notification. If this kind of curbs are placed on researchers and research journals, it has a bad portend,” says Prof. Subhash C. Lakhotia from Banaras Hindu University, Varanasi. He has been working to understand the mechanism of action of some standard Ayurvedic rasayanas. “If we want to get results as desired by AYUSH ministry or AYUSH practitioners, then that is not research.”

While he concurs that it is desirable to involve AYUSH experts in a study, he is peeved that it is now being made mandatory. “How can the ministry insist that every study should involve an expert? It should be left to the choice of the researchers,” he says. He believes that the need of a domain expert would be context-dependent and should not be a mandatory requirement in every case. The domain expert has to be a collaborator rather than a monitor, says Prof. Lakhotia.

Prof. Lakhotia adds: “Ayurveda as currently practiced, remains a black box and unless people from other fields contribute to its understanding, it will only worsen the situation. He adds: “The way Ayurveda has been practiced is not evidence-based but largely remains experience-based. Only good quality, unbiased research can provide the evidence for or against what has been believed. Results of such studies may even change some of the basic principles. Any domain of knowledge has to remain dynamic and results/opinions contrary to the so-called established views must not be rejected and taken as damaging the credibility.”

A few scientists support the advisory

However, Dr. Mitali Mukerji, a senior scientist at the Institute of Genomics & Integrative Biology (CSIR-IGIB), who has been studying the principles of Ayurveda for about 15 years says it is essential to collaborate with an Ayurveda expert while carrying out a scientific study. Taking a closer scientific look at Ayurvedic medicine using modern technologies should be in the interest of all stakeholders — patients, doctors and researchers, she says. “I have gained much by collaborating with Dr. Bhavana Prasher, an Ayurveda expert who is also a scientist at CSIR-IGIB,” Dr. Mukerji says.

Dr. Samir K. Brahmachari, former Director-General of the Council of Scientific & Industrial Research (CSIR) and founding Director of CSIR-IGIB says: “Any research work on Ayurveda drug or treatment should involve an Ayurveda expert. A domain expert is necessary. What is wrong in that?”

Published in The Hindu on April 7, 2019

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