Lok Sabha Question No. 78 (STARRED), answered on 2021-07-23
Subject: AYUSH-64
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Reddeppa Nallakonda Gari, T.R.V.S. Ramesh

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

## LOK SABHA STARRED QUESTION NO. 78 TO BE ANSWERED ON 23 RD JULY AYUSH - 64

## *78. SHRI N. REDDEPPA: SHRI T.R.V.S RAMESH:

Will the Minister of AYUSH be pleased to state:

- (a) whether the Government has undertaken clinical trials in the country t AYUSH - 64 has notable anti - viral, immune - modulator and anti - pyretic properties;
- (b) if so, the details thereof;
- (c) whether AYUSH - 64 has been found to be useful in the treatment of asympt mild and moderate COVID - 19 infection and if so, the details thereof; and
- (d) whether the said drug is currently repurposed for use in COVID - 19 treatment and if so, the det ails thereof?

## ANSWER THE MINISTER OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

(SHRI SARBANANDA SONOWAL)

- (a) to ( d)A Statement is laid on the Table of the House.

## , 2021

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 78* FOR 23 RD JULY , 202 1

- a) Yes, Sir.

b) Ministry  of Ayush  has formed  an  Interdisciplinary  Ayush  R&D  Task  Force chaired  by  Prof.Bhushan Patwardhan and  having  representation  from  scientists including ICMR, DBT, CSIR, AIIMS and AYUSH Institutions.  The Interdisciplinary Ayush Research and Development Task Force has formulated and designed clinical research  protocols  for  prophylactic  studies  and  add-on interventions  in  COVID-19 positive  cases  through  thorough  review  and  consultative  process  of  high  repute experts  from  different  organizations  across  the  country for studying  different interventions. AYUSH-64 is one of the formulation identified for the clinical studies. The  drug  was  developed Central Council  of  Research  in  Ayurvedic Sciences (CCRAS), an autonomous research organization, under Ministry of AYUSH in 1980 through  extensive  pharmacological,  toxicological,  and  clinical  studies  for  infective febrile conditions like Malaria.

Based on the empirical evidence, AYUSH-64 was repurposed for COVID-19 and extensive studies  viz.  in-silico,  in-vitro  and  clinical  studies  were  conducted  to evaluate its therapeutic potential. Accordingly, CCRAS conducted five clinical trials on AYUSH-64 in  asymptomatic  and  mild  to  moderate  cases  of  COVID-19 as standalone  or  adjunct  to  standard  conventional  care. Other  clinical  studies  on AYUSH-64 were conducted  at  Institute  of  Teaching  and  Research  in  Ayurveda (ITRA),  Jamnagar  and  National  Institute  of  Ayurveda  (NIA),  Jaipur,  autonomous organizations under Ministry of Ayush. These studies were registered with Clinical Trial Registry of India (CTRI) under Indian Council of Medicinal Research (ICMR). These clinical studies on AYUSH 64 were monitored and reviewed periodically by Data and Safety Monitoring Board (DSMB). The clinical studies on AYUSH 64 were undertaken in collaboration with 09 reputed institutions which include King George Medical  University,  Lucknow,  All  India  Institute  of  Medical  Sciences,  Jodhpur, Government Medical College, Nagpur, Datta Meghe Institute of Medical Sciences, Wardha,  Bombay  Municipal  Corporation COVID  Care  Centre, Mumbai,  Shri Dhanwantri Ayurvedic  College,  Chandigarh,  Guru  Govind  Singh  Government

Medical  Hospital,  Jamnagar,  Ayurveda  and  Unani  Tibbia  College,  New  Delhi  and Chaudhary Brahm Prakash Ayurved Charak Sansthan, New Delhi. c) The research outcomes of the clinical trials has demonstrated efficacy of AYUSH64  in  the  treatment  of  asymptomatic  &  mild  cases  as  standalone  and  for  the management of mild and moderate COVID-19 as an adjunct to standard care. It was observed  that  AYUSH-64  as  adjunct  treatment  to  Standard  Care  resulted  in significant  improvement  in  clinical  recovery,  reduced  duration  of  hospital  stay without any progression of the disease to severe or critical stage. Also, there was improvement in Quality of life (QoL) parameters. AYUSH-64 was found to be well tolerated and clinically safe. The preprints of three clinical trials are available online. d) Yes, Sir. The AYUSH-64  has  been  repurposed for the  management  of asymptomatic and mild to moderate cases of COVID-19 and has been recommended  in National  Clinical  Management  Protocol  based  on  Ayurveda  and Yoga for management of COVID-19. During the second outbreak of COVID-19 in India, the Ministry of AYUSH has also launched  nation-wide campaign  through  its  Research  Councils  and  National institutes for mass distribution of AYUSH-64 to asymptomatic and mild to moderate COVID-19 patients in home isolation. Further, the technology of Ayush-64 has been transferred  to  29  Ayush  Pharmaceutical  manufacturing  units  for  repurposing  of COVID-19.

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