File No.1-13020/8/2021 -DCC I

Government of Ministry of AYUSH

NBCC, Office Block-3, 2 Floor East Kidwai Nagar, New Delhi-110023 Dated: May, 2021

To,

All manulacturers to which AYUSH 64 Technology has been transferred through CCRAS.

Subject:- Supply of AYUSH-64 to National Institutes/State Institutes through the aegis of CCRAS amid COVID-19-reg.

Sir, Please refer to the meeting held on 30.04.202 1, to discuss to increase the production and supply of AYUSH-64 to the Government Institutes.(Minutes enclosed). In this regard, the undersigned is directed to say that, if you are willing to supply the AYUSH-64 @Rs.104.80 for 40 tablets + GST as applicable (the rate quoted by IMPCL) to the National Institutes/State Institutes through the aegis of CCRAS then please intimate your concurrence to the Ministry. This issues with the approval of Competent Authority.

Digitally signed by DR. CHINTA SRINIVAS RAO Date:Wed May 05 1 1:24:58 1ST 2021 Reason: Approved (Dr. S.R.Chinta) Deputy Adviser Drug Policy Section

Copy for necessary action to:

Dr. Ravindra Kumar, Assistant Director & Nodal Officer, Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa Avum Anusandhan Bhavan No.61-65, Institutional Area, Opp. 'D' Block, Janakpuri, New Delhi - 110058 2

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Minutes of meeting through VC with manufacturers of AYUSH-64 on Friday, 30.4.202 1 from 4-5prn.

A meeting was held through video conferencing on 30.04.2021 to discuss the increasing the production and supply of AYUSH 64.

A list of participants is placed at Annexure 1.

At the outset, Chairman of the meeting, Dr J L N Sastry, CEO(NMPB) & In charge Drug Policy Section, Ministry of AYUSH welcomed the participants and cited the objective of the meeting wherein the Ministry wants to hear the capacities, timelines and constraint including raw material issues which are required for bulk and fast track manufacturing of AYUSH-64 Formulation so that the same can be solved with collaborative efforts. He then asked Dr N Srikanth, Deputy Director, CCRAS to give a brief account of AYUSH64.

Dr N Srikanth stated that AYUSH 64 is a patented Ayurvedic medicine of Central Council for Research in Ayurvedic Sciences (CCRAS), New Delhi, indicated for Malaria. It was subjected to clinical trial for studying its efficacy in COVID 19 patients under joint initiative on Clinical trials of Four AYUSH Interventions for COVID- 19 under CSIR-Ministry of AYUSH. After the trial it was found that Add-on arm had showed a significant reduction in time to recovery (primary efficacy) as compared to the standard of care arm. Also, the safety and tolerability profile was good.

The Monitoring Committee of CSIR-Ministry of AYUSH Joint Initiative on Clinical Trials of four AYUSH Interventions for COVID-19 has also recommended that AYUSH-64 be positioned as an intervention for the management of asymptomatic, mild to moderate COVID- 19 through repurposing and as recommended by the Interdisciplinary Committee, the AYUSH 64 was included in the National Clinical Management Protocol Based on and Interventions for the management of Asymptomatic and mild to moderate cases of COVID- 19. It has also been endorsed by Ministry of AYUSH in a press conference on 29th April 2021.

Dr Srikanth also stated that NRDC has been entrusted to commercialise the technology of CCRAS and Dr Ravindra Singh, AD, CCRAS is the nodal officer for the matter while in NRDC Mr V K Jam is the contact person. Further he told that all the other relevant information is available on website of CCRAS.

Mr Mukesh Kumar, IMPCL that they have 2 lakhs tablets ready for order, while they can produce about 5 crore tablets in next 30days. They have a capacity to produce 15 lakhs tablets/day. They also stated that if further orders come at this time it will be little difficult due to present COVID-19 crisis situation. 161324120211DPS

Dr C K Katiyar on behalf of Zandu stated that their production is in bad shape due to the current but they can manufacture 2 lakh tabs /month and if demand is more they will ramp up the productions.

Meanwhile Dr Sastry informed that the immediate demand of AYUSH 64 is around 8 crore tablets and we are looking forward from pooling in from such manufacturers which will be able to ftilfill the demand immediately.

Mr J P Singh of Shree Dhanwantri stated that they already have required capacity and technology with them for manufacturing AYUSH 64. Further Mr Singh has informed that they can produce around 3 crore tablets in one month but raises a concern regarding the availability of Saptaparna Bark (one of the ingriedients of AYUSH64).

Dr Sastry has informed that NMPB will connect the manufacuring company with genuine supply vendor.

Dr Pradeep Multani, of Multani Pharmaceuticals has stated that they already have license and have capacity of producing 20 lakhs tablets/day but raises following concern-

• They have their License for AYUSH 64 in Delhi but their major manufacuring unit is situated in Uttarakhand. • Due to increase demand of raw materials of ingriedients price will be at sky rocket, so how to control the situation.

Dr Sastry informed that extension of license from one state to another state will be applicable soon, meanwhile a DO letter from Secretary(AYUSH) to Principal Secreatries of all States and a memorandum from Drug Policy Secion to all State licensing authorities already have been sent to expedite the process of licensing of AYUSH 64. It will also be seen that manufacturers applying for new license for manufacturing AYUSH 64 if provide an undertaing to CCRAS to adhere to the terms and conditions of the technology transfer then it will be seen that license to them is issued within 48 hrs.

Dr D. Prasad from Dabur India informed that they have a capacity of production of 1-5 lakhs/day. He further requested that NMPB make sure for adequate supply of raw materials from vendor and also share the details of extract units of the indredients used in the product.

Dr Rajib Choudhary on behalf of Zandu pointed out some imprtant issued which needs to be addressed which are:-

• What will be written for the label claim and in this regard a clarification of label should be provided. • For license what supportive literature report is to be submitted, CCRAS may provide that and an interim report will also be of help. 3

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Price capping of the medicine as it is for mass supply.

To this Dr Sastry informed that the supply of AYUSH 64 will be made to free market and offices. Price capping is not thought of now but will be conveyed in due course of time.

Dr Sastry also informed that the label claim will be written as "for the management of Asymptomatic and mild to moderate cases of COVID-19 along with standard of care".

Dr Srikanth regarding literature report stated that 1st report of AYUSH 64, Interdisciplinary Committee, National Clinical Management Protocol Based on Ayurveda and Yoga Interventions, Ministry of AYUSH press conference on 29 th April 2021 is already available on CCRAS website.

Dr. Maheshwari from Jamna Herbals informed that they have a capacity of producing 5 Iakhs tablets/day and 1.5 crore tablets/month. They aslo had query regarding the tendering process. To this Dr. Sastry stated that this is and emergency situation so there is no tendering process but the manufacturing units will be connected to the institute or State which raises requirement for direct procurement at a rate which will be conveyed subsequently.

Mr. Faiz Au from Unijules informed that they have capacity to produce 1.5 crore in next month and after that 3 crore tablets/month. They also informed that they have been marketing the product as AYUSH 64 only which is prescribed as per agreement with CCRAS and also the formulation produced by Unijules is exactly like that provided by CCRAS and there is no shortcut adopted by them in the process. It was decided in the meeting unanimously that standard size of the AYUSH 64 packing will be 40 tablets/pack except Zandu who are manufacuring it as 10 tablets/strip pack.

Ms Kiran Khanduri, M/s Pravek Kalp has stated that they have a capacity to produce 2.5 lakh tablets/week.

Mr Ranjit Puranik of Dhootpapeshwar informed that they have capacity to produce 2-3 crore tablets/month if there license application is approved on fast track.

Dr Sastry keeping a note of the capacity of production of AYUSH 64 of each manufacturer requested them to once again review their production capacity and raw material stock and to be in tough with the Drug Policy Section and NMPB in this regard and further directions will be issued soon.

The meeting ended with a vote of thanks to the Chair. 6 1613241202110 PS

3n. r FTfH ir4'. Ri, ii (mi) iTri 3TT 1T, 'efl, ft311 , T IT i)"1T T f.11--11oo23 Vaidya Rajesh Kotecha SECRETARY COVER NME NT OF IN DIA MINISTRY OF AYURVEDA YOGA & UNANI, SIDDHA SOWA-RIGPA AND HOMOEOPATHY (AYUSH AYUSH BHAWAN, B-BLOCK, GPO COMPLEX INA, NEW DELHI-110023 Tel. 011-24651950, Fax 011-24651937 E-mail : [email protected]

D.O. No. T-18020/1/2020-DCC-Part(1) 28m April, 2021 Dear Chief Secretary,

As you are aware, in the process of combating COVID 19 outbreak, the need for public use of Ayush based immuno-modulator products and medicines has been significantly emphasized and their demand has increased manifold. In this regard, I would like to inform that AYUSH 64, an Ayurvedic medicine was developed in compliance to all regulatory requirements and quality and pharmacopoeial standards by the Central Council for Research in Ayurvedic Sciences (CCRAS), an apex body for research in Ayurveda under the Ministry of AYUSH. This drug based on its ingredients having notable antiviral, immuno-modulator and antipyretic properties.

The Ministry of Ayush and CSIR collaboration has recently completed a robust multi- centre clinical trial to evaluate the efficacy and safety of AYUSH 64 in the management of mild to moderate COVID-19 patients and the results are highly encouraging and AYUSH 64 can be positioned as specific intervention for the management of asymptomatic, mild to moderate COVID-19 infection. Beside this the outcome of seven other clinical studies revealed that AYUSH 64 exhibit early clinical recovery in COVID-19 cases and help protect from progression of the disease to severe or critical stage.

This medicine is also recommended in National Clinical Management Protocol based on Ayurveda and Yoga for the management of asymptomatic and mild to moderate cases of COVID-19 which was vetted by National Task Force on COVID Management of ICMR (copy enclosed).

Therefore, utilization of AYUSH 64 in the asymptomatic, mild to moderate COVID-19 patients admitted in the hospital or isolated in their home is to be promoted under National Ayush Mission. State Licensing Authorities have been advised separately to facilitate Ayush Industries to increase production of AYUSH 64.

I, therefore, request you to do the needful for issuing necessary directions to the State Health Authorities to promote the use of AYUSH-64 as per National Clinical Management Protocol Based on Ayurveda and Yoga interventions.

With regards, Yours sincerely, RAJESH End. As above KU MAR KOTECHA (Rajesh Kotecha)

To,

Chief Secretaries of all States! UTs