Ayush ministry to crack whip on research studies with ‘unfounded statements, conclusions’ to protect credibility

In a bid to improve the credibility of traditional medical systems, the Ayush ministry has decided to crack whip on research papers and scientific studies on drugs and therapies with “unfounded statements and conclusions”.

Henceforth, all researchers and institutions are advised to involve appropriate research council or experts of Ayurveda, Naturopathy, Unani, Siddha and Homoeopathy systems in conducting any scientific study, clinical trial or research intervention to explore Ayush drug or treatment. The study outcomes and findings should also be vetted by these experts to prevent “incorrect, arbitrary and ambiguous statements and conclusions”.

In an advisory issued last week, the ministry observed that many of the studies by non- Ayush researchers were conducted without the involvement or endorsement of government-appointed research councils or relevant subject experts. “Potential and scope of Ayush in public healthcare cannot be jeopardised and people may not be distracted or dissuaded from resorting to Ayush from arbitrary statements and unfounded conclusions,” the advisory noted. 

The advisory is expected to be followed by all researchers, scientists and investigators, the Medical Council of India (MCI), all Ayush research councils, Indian Council of Medical Research, Council for Scientific and Industrial Research and Department of Biotechnology.

“Ayush systems are officially recognised as an integral part of the country's healthcare delivery network and are promoted and mainstreamed through various policies, strategies and schemes of government of India including the National Health Policy 2017, National Health Mission and National Ayush Mission. Principles, concepts and approaches of Ayush systems and their drug-based interventions are not at all comparable to the prevalent modern medical system. For scientific development of Ayush systems, Central government has inter alia established five research councils, published Good Clinical Practice (GCP) guidelines and implemented Extramural Research Scheme to support projects of scientific exploration,” the advisory further adds. 

The ministry has been tweaking regulatory parameters from time to time to enhance transparency and trustworthiness in Ayush drug development. The norms were revised recently to ensure that no licence for drug production was granted without good manufacturing practice compliance. Moreover, all states and union territories are directed to set up expert committees to verify drug ingredients and efficacy. These panels will scrutinise the licence application, proof of concept and testing protocols of intended patent or proprietary drug as provided in Section 3 of the Drugs and Cosmetics Act of 1940. It will also examine the reference of the proposed drug and its ingredients from authoritative books to ascertain that the excipients used in the formulation are in accordance with the rules.

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=115126&sid=1