Dr Harsh Vardhan launched ‘Ayush Sanjivani’ app and interdisciplinary studies involving AYUSH interventions for COVID-19
Dr Harsh Vardhan, Union Health & Family Welfare Minister launched the ‘AYUSH Sanjivani’ App and two AYUSH-based studies related to COVID-19 situation on 7th May, 2020 in the presence of Shri Shripad Yesso Naik, MoS (I/c), AYUSH who participated through Video Conferencing from Goa. Highlighting the importance of harnessing technology for COVID-19 response, the Union Health Minister said “The ‘AYUSH Sanjivani’ mobile app, which has been launched today, will help to generate data on acceptance and usage of AYUSH advocacies and measures among the population and its impact in prevention of COVID 19. It is developed by Ministry of AYUSH and MeitY and shall reach out to a target of 50 lakh people.” Dr Harsh Vardhan stated that COVID-19 management has provided a potent platform for alliance between MoHFW, MoAYUSH and technology organisations such as CSIR, ICMR, and UGC to not only develop AYUSH interventions and solutions but also help in promoting AYUSH knowledge for the larger good of the global community. These organisations are joining hands today and are being supported and guided by ICMR and DCGI in propagating the wholesomeness and holistic health benefits of the age-old traditional medicinal knowledge of Ayurveda, he added. In addition to the App, Dr Harsh Vardhan also launched two more scientific studies. One is the collaborative clinical research study on Ayurveda interventions as prophylaxis and as an add-on to standard care to COVID 19, which shall be a joint initiative of Ministry of AYUSH, MoHFW and the Ministry of Science & Technology through Council of Scientific & Industrial Research (CSIR) with technical support of ICMR. The Interdisciplinary Ayush R&D Task Force headed by Dr Bhushan Patvardhan, Vice Chairman, University Grant Commission (UGC) has formulated and designed clinical research protocols for prophylactic studies and add-on interventions in COVID-19 positive cases Impactful S&T efforts initiated in last quarter 69 through thorough review and consultative process of experts of high repute from different organisations across the country for studying four different interventions, viz., Ashwagandha, Yashtimadhu, Guduchi Pippali and a poly herbal formulation (AYUSH-64). This includes the following two areas: a. Ashwagandha for the Prophylaxis against SARS-COV-2 in subjects with increased risk during the COVID 19 Pandemic: A comparison with Hydroxychloroquine in the healthcare providers and b. Effectiveness of Ayurveda Formulation as an adjunct to ‘Standard of Care’ for the Treatment of Mild to Moderate COVID-19: A Randomized, Open Label, Parallel Efficacy, Active Control, Multi-Centre Exploratory Drug Trial. Dr Harsh Vardhan also launched the population-based interventional studies on impact of AYUSH-based prophylactic interventions for prevention of COVID-19 infection in high risk population. The core objectives comprise of assessment of preventive potential of AYUSH interventions for COVID-19 and to assess the improvement in quality of life in high risk population. The study will be carried out through four Research Councils under Ministry of AYUSH and National Institutes in 25 states across the country and several State Governments covering approximately 5 lakh people. The outcome of the study is expected to pave a new horizon in understanding the preventive potential of AYUSH interventions during pandemics like COVID-19 through scientific evidence. Elaborating on the import of these studies, Dr Harsh Vardhan stated that these studies shall reestablish the importance of AYUSH pathies with the help of rigour of CSIR, ICMR and DCGI. “This is truly a momentous day. The technology alliance provides valuable opportunity for such knowledge-based solutions to continue to benefit us even after the COVID-19 pandemic has passed, by possible integration of AYUSH in the mainstream scientific efforts,” he added. “Let us also understand that the modern pathies of medicine and science are not in competition with those of AYUSH, but they complement and strengthen each other in intrinsic ways,” Dr Harsh Vardhan stated. “Under the leadership of our beloved Prime Minister, AYUSH advisories for enhancing immunity during COVID-19 pandemic have been acknowledged the world over,” he said. Shri Rajesh Bhushan, OSD/Secretary (HFW), Shri Vaidya Rajesh Kotecha, Secretary, AYUSH, Dr Shekhar C. Mande, Director General, CSIR, Dr V. G. Somani, Drugs Controller General of India, and other senior officers of MoHFW and AYUSH were also present at the launch event.
Ministry of AYUSH issued advisory for meeting the challenge arising out of spread of Novel Coronavirus in India
The holistic approach of AYUSH systems of medicine gives focus on prevention through lifestyle modification, dietary management, prophylactic interventions for improving the immunity and simple remedies based on presentations of the symptoms. For instance, emphasis on avoidance of causative factors and enhancing the immunity against host of infections are characteristics of Ayurveda management. The preventive aspect of Homoeopathy is well known, and historically, Homoeopathy has reportedly been used for prevention during the epidemics of Cholera, Spanish Influenza, Yellow fever, Scarlet fever, Diphtheria, Typhoid etc. The Genus Epidemicus (GE) is the remedy found to be most effective for a particular epidemic once data have been gathered from several cases. It was reported that, during recent past GE had been used during various disease outbreak for preventing the spreading of diseases like Chikungunya, Dengue Fever, Japanese Encephalitis and Cholera with good results. 70 The AYUSH approach to manage the outbreak broadly comprise of:
Preventive and prophylactic;
Symptom management of COVID-19 like illnesses; and
Add on interventions to the conventional care.
Notification issued for undertaking research on COVID-19 through Ayurveda, Unani, Siddha and Homoeopathy systems by Ministry of AYUSH
IIn the wake of COVID-19 caused by SARS CoV-2, there has been surge in proposals received by Ministry of AYUSH claiming possible treatment of COVID-19. At present, there is no approved treatment for COVID-19 infection. Indian Traditional Medicines have wide potential for usage in such conditions owing to their longstanding use in the community, huge number of ancient references and large number of publications in scientific journals on their phytochemical constituents, mode of action, clinical efficacy etc. At the same time, it is also essential to have scientific evidence on use of any Ayurveda, Unani, Siddha or Homeopathy formulation on prevention/ management of COVID-19. Therefore, it is felt necessary to make serious efforts for development of drugs based on any of AYUSH systems recognized under Drugs and Cosmetics Act, 1940. There are no specific regulatory provisions in the Drugs & Cosmetics Rules 1945, for conduct of clinical trials of Ayurveda, Siddha, Unani and Homeopathy drugs. At the same time it is also necessary that the clinical data generated is scientifically valid and credible. In this context the Ministry has undertaken consultation with DCGI, CDSCO as well as other research experts. In the above background and based on the consultation of CDSCO, the Ministry of AYUSH with the approval of Minister of State Independent Charge of AYUSH notifies that the scientists, researchers, clinicians of any of recognized systems of medicine under IMCC Act 1970, HCC Act 1973 and NMC Act 2019 (formerly IMC Act 1956) can undertake research on COVID-19 through Ayurveda, Siddha, Unani and Homeopathy systems including prophylactic measures, intervention during the quarantine, asymptomatic and symptomatic cases of COVID-19, public health research, survey, lab-based research etc. to generate evidence. While undertaking research, it is mandatory for the organizations to comply with the following conditions:
The proposal should be approved by their scientific advisory bodies and Institutional Ethics Committees. If it is clinical trial, the project should be registered with CTRI.
The sample size should be based on statistical justification.
The clinical research should be conducted as per AYUSH guidelines for Clinical Research or ICMR guidelines.
It should comply with relevant regulations for Bio-medical and Health Research.
It should comply with Good Clinical Practice Guidelines.
It should comply with National Ethical Guidelines for Bio-medical and Health Research on Human Participation published by ICMR.
It should comply with any other relevant regulations in force.
AYUSH registered practitioner/expert should be part of the study team at each site.