Lok Sabha Question No. 162 (STARRED), answered on 2021-07-30
Subject: Licensing for AYUSH-64
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Adala Prabhakara Reddy, Chandra Sekhar Bellana

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

## LOK SABHA STARRED QUESTION NO. 162 TO BE ANSWERED ON 30 TH JULY , 2021 LICENSING FOR AYUSH - 64

## *162. SHRI ADALA PRA BHAKARA REDDY: SHRI CHANDRA SEKHAR BELLANA:

Will the Minister of AYUSH be pleased to state:

- (a) the number of companies that have come forward to obtain licence for man AYUSH - 64, State/ UT - wise;
- (b) the details of approvals given to such companies by Stat e Licensing Authorities along with the brand/ market names of this drug;
- (c) whether the transfer of technology for such companies is possible throug Council  for  Research  in  Ayurveda  Science  (CCRAS)  and  the  National  Researc DevelopmentCentre (NRDC); and
- (d) if so, whether the Central Council for Research in Ayurveda Science (CC provide technical support to the Ayurveda, Siddha, Unani (ASU) drugs manufac the manufacturing of AYUSH - 64 and if so, the details thereof?

## A NSWER 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.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 162* FOR 30 TH JULY , 202 1

- (a) The list of manufacturers to whom AYUSH 64 technology has already transferred  through  agreement  from National  Research  Development  Corporation ( NRDC)  and Central Council for Research in Ayurvedic Sciences ( CCRAS) as on 23.7.2021 is placed at Annexure - I which is also available at CCRAS's website www.ccras.nic.in .
- (b) The information obtained from the SLAs regarding details of approvals such  companies  along  with  th e  brand/market  names  of  this  drug  is  placed Annexure - II.
- (c) Yes, the details and the procedure are annexed as Annexure III .
- (d) After  technology  transfer  to  a  Manufacturer  by  NRDC  and  CCRAS complete  Know- how  document  of  AYUSH - 64  containing  all  relevant information, required  for  production  is  provided  to  the  manufacturer.  If  requir manufacturer,  provision  for  training  is  also  available.  Also,  to  facil holders, CCRAS has issued a Notification dated 30.04.2021 for commerciali f AYUSH - 64 developed by CCRAS.

## LIST  OF  MANUFACTURING  UNITS  TO  WHICH  AYUSH  64  TECHNOLOGY  HAS  BEEN TRANSFERRED TILL DATE (23.07.2021)

|   Sl. No. | Name of the Company                                                                                                                          | State/UT         | Year of Technolog y transfer   | Contact Email                                          |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------|--------------------------------------------------------|
|         1 | M/s Indian Medicines Pharmaceuticals Co. Ltd. (IMPCL), Mohan, Ramnagar, Distt. Almora                                                        | Uttarakhand      | 1995 &2014                     | mdimpcl@gmail . in                                     |
|         2 | M/s Multani Pharmaceuticals Ltd. , New Delhi.                                                                                                | NCT of Delhi     | 2012                           | support@multani.org, +91 7290003591, 011-4151 3323     |
|         3 | M/s Upkaran Pharmaceuticals , Shop No. 25, Board Office Square, Zone-II, MaharanaPratap Nagar, Bhopal, Madhya Pradesh 462011                 | Madhya Pradesh   | 2012                           | 0755 255 5758                                          |
|         4 | M/s Dabur India Pvt. Ltd. , Sahibabad, Ghaziabad                                                                                             | Uttar Pradesh    | 2016                           | Mr. ByasAnand, Email Id: corpcomm@dabur.com            |
|         5 | M/s Jamna Herbal Research Limited , 15, Zone-II, MaharanaPratap Nagar, Bhopal                                                                | Madhya Pradesh   | 2017                           | jamna151@gmail.com                                     |
|         6 | Uttarakhand State Medicine &Pharmaceuticals Ltd., Haldwani, U.K.                                                                             | Uttarakhand      | 2020                           | 05945-268056                                           |
|         7 | M/s Sarvotham Care Limited, 197, Nicholson Road, Tadbund, Secunderabad, Telangana-500009                                                     | Telangana        | 29.04.2021                     | piyush.k@sarvothamcare.com nookesh.k@sarvothamcare.com |
|         8 | M/s Dindayal Industries Ltd. , 5-6, Industrial Estate, Tansen Road, Birla Nagar, Gwalior- 474004, M.P.                                       | Madhya Pradesh   | 17.05.2021                     | sunil.m@dindayalgroup.com aditya.c@dindayalgroup.com   |
|         9 | M/s Dhootpapeshwar Ltd ., Veer SavarkarChowk, Panvel, Raigad-410206, Maharashtra                                                             | Maharashtra      | 17.05.2021                     | rap@sdlindia.com                                       |
|        10 | M/s Dhatri Ayurveda Pvt. Ltd .,33/1882B, Adappilly Road, Ernakulum, Kerala                                                                   | Kerala           | 18.05.2021                     | rajeshkumar.a@dhathri.com                              |
|        11 | M/s Tirupati Medicare Ltd ., Paonta Sahib, Distt. Sirmour, H.P.                                                                              | Himachal Pradesh | 18.05.2021                     | prabhat.verma@tirupatigroup.co.i n                     |
|        12 | M/s SrivedaSattva Private Ltd ., Third Floor, No. 54/46, 39 th ACross, 11 th Main Road, 4 th T Block, Jayanagar, Bangalore, Karnataka-560041 | Karnataka        | 19.05.2021                     | dr.ravireddy@srisritattva.com                          |

|   Sl. No. | Name of the Company                                                                                                                 | State/UT             | Year of Technolog y transfer   | Contact Email            |
|-----------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------------------|--------------------------|
|        13 | M/s Revinto Life Science Pvt. Ltd, Plot No. 21, KIDAB Industrial Area, Shirwada, Karwar, Uttara Kannada District, Karnataka- 581306 | Karnataka            | 21.05.2021                     | info@revinto.in          |
|        14 | M/sKarnani Pharmaceuticals Pvt Ltd. 19/23,Vithoba Lane, Vithalwadi, Mumbai, Maharashtra- 400002                                     | Maharashtra          | 21.05.2021                     | ajay@karnani.co.in       |
|        15 | OMPharmaceuticals Ltd., 202, Vishwa Nanak Apartments, GurunanakWadi, Chakala, Andheri (East), Mumbai, Maharashtra- 400099           | Maharashtra          | 21.05.2021                     | oplfinance@ompharma.in   |
|        16 | Karnataka Antibiotics& Pharmaceuticals Ltd ., Dr. Rajakumar Road, First Block, Rajajinagar, Bangalore-560010                        | Karnataka            | 27.05.2021                     | hodpharma@kaplindia.com  |
|        17 | M/s DeshRakshakAushdhalya Ltd ., Kankhal, Haridwar- 249408                                                                          | Uttarakhand          | 27.05.2021                     | dral95@yahoo.com         |
|        18 | M/s S.D.P. Remedies and Research Centre , Business Office at Udayagiri, Korungu, Kemminje, Village Puttur, DK, Karnataka- 574202    | Karnataka            | 27.05.2021                     | sdpayurveda@gmail.com    |
|        19 | M/s MeghdootGramodyogSewaS ansthan , A1/18, Sector- H, PuraniyaChauraha, Aliganj, Lucknow , U.P.                                    | Uttar Pradesh        | 27.05.2021                     | vimal@meghdootherbal.com |
|        20 | M/s Amulya Labs Private Ltd. , Plot No 74, Industrial Estate HSIIDC, Alipur, Barwala, Panchkula, Haryana- 134118                    | Haryana              | 31.05.2021                     | vish.gupta134@gmail.com  |
|        21 | M/s Uma Ayurvedics Private Ltd ., MadhavPuri, Nadrai Gate, Kasganj (Etah), - 207123, U.P.                                           | Uttar Pradesh        | 31.05.2021                     | umaayurved@hotmail.com   |
|        22 | M/s Basic Ayurveda 46, Anand Industrial Estate, Mohan Nagar, Ghaziabad- 201007, U.P.                                                | Uttar Pradesh        | 31.05.2021                     | basicayurveda@gmail.com  |
|        23 | M/s Alna Biotech Pvt. Ltd. SCF 1013, Ground Floor Motor Market, Manimajra, Chandigarh-160101                                        | Haryana jurisdiction | 03.06.2021                     | care@alnabiotech.com     |

|   Sl. No. | Name of the Company                                                                                                                | State/UT         | Year of Technolog y transfer   | Contact Email                                          |
|-----------|------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------|--------------------------------------------------------|
|        24 | M/s Pharmaveda (India) Private Ltd. B-4 Kamdar Shopping Centre, Opp Railway Station Vile Parle (East), Mumbai, Maharashtra- 400057 | Maharashtra      | 03.06.2021                     | sagartungare@pharmaveda.com                            |
|        25 | M/s Pharmaceutical Corporation (IM) Kerala Ltd. Kuttanellur P.O., Trissur, Kerala-680014                                           | Kerala           | 04.06.2021                     | oushrd@gmail.com                                       |
|        26 | M/s Amar Pharmaceuticals and Labs (India) Pvt. Ltd. 17/110 NawabCompound,RamNarai n Bazar, Kanpur, Uttar Pradesh-208001            | Uttar Pradesh    | 07.06.2021                     | amarpharma107@gmail.com                                |
|        27 | M/s Shree Dhanwantri Herbals, Village Kishanpura, Tehsil Nalagarh, District Solan, Himachal Pradesh-174101                         | Himachal Pradesh | 07.06.2021                     | gauravarora@shridhanwantri.com                         |
|        28 | M/s Maheshwari Pharmaceuticals (India) Ltd. , Plot No. 7, Sector 6B IIE SIDCUL, Haridwar,Uttarakhand- 249403                       | Uttarakhand      | 07.06.2021                     | info@mpil-herbal.com                                   |
|        29 | M/s HLL Lifecare Limited HLL Bhavan, Mahilamandiram Road, Poojappura, Thiruvananthapuram, Kerala- 69                               | Kerala           | 09.06.2021                     | sampathkumar@lifecarehll.com, hll.bharat0407@gmail.com |
|        30 | M/s Bipha Drug Laboratories Private Ltd . XIII/804, Pallipurathukavu Junction, Kottayam, Kerala- 686039                            | Kerala           | 11.06.2021                     | gm@bipha.com                                           |
|        31 | M/s Himalaya Research Laboratory, EPIP, Bari Brahmna, Jammu-181133                                                                 | J&K              | 11.06.2021                     | ved@himalayaresearchlaboratory.c om                    |
|        32 | M/s Mangalam Biotech Research 39/23, 2nd Floor, Lane No. 15, Sameyapur Industrial Area, Delhi-110042                               | Delhi            | 11.06.2021                     | manglambiotechresearch@gmail.c om                      |

|   Sl. No. | Name of the Company                                                                                                     | State/UT       | Year of Technolog y transfer   | Contact Email                  |
|-----------|-------------------------------------------------------------------------------------------------------------------------|----------------|--------------------------------|--------------------------------|
|        33 | M/s North India Life Sciences Private Limited Plot No-430, Sec-3, HSIIDC Karnal, Haryana- 132001                        | Haryana        | 14.06.2021                     | northindiapharma@ymail.com     |
|        34 | M/s Nirav Healthcare, Plot No. 25, GIDC Phase-I, Industrial Estate, Rajpipla, Narmada, Gujarat-393145                   | Gujarat        | 29.06.2021                     | fdca.niravhealthcare@gmail.com |
|        35 | M/s Minor Forest Produce Processing &Research Centre, Van Parisar, Barkheda, Pathani, Bhopal- 462021                    | Madhya Pradesh | 01.07.2021                     | mfpparc@gmail.com              |
|        36 | M/s Multi State Cooperative Pharmaceuticals &Research, Lane No. 1, MangalParao, Haldwani, Nainital -263139, Uttarakhand | Uttarakhand    | 08.07.2021                     | multistatecoop354@gmail .com   |
|        37 | Co-operative Drug Factory Udyog Nagar, Ganiadeoli, Ranikhet, Almora, Uttarakhand-263645                                 | Uttarakhand    | 20.07.2021                     | ranikhetcdf@gmail.com          |

Updated as on 23.07.2021

## Annexure - II LIST OF LICENSED MANUFACTURERS OF AYUSH 64 ALONGWITH THEIR BRAND/MARKET NAMES OF THE DRUG

|   S.No. | State/UT         | Company Name                                                                                                           | Brand Name               |
|---------|------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------|
|       1 | Karnataka        | i. M/s OM Pharmaceuticals ltd., 12 th Mile stone old Madras Road, Virgonagar post, bengluru - 49                       | AYUSH - 64               |
|       1 | Karnataka        | ii. M/s Revinto Life Science Pvt. Plot No.21, KIDAB Industrial Area, Shirwad, Karwar - 581301                          | Ltd, Recomax(AYUSH - 64) |
|       1 | Karnataka        | iii. M/s SDP Remedies & Research Centre, 2 - 120(2), Udayagiri, Mundoor, PutturTalukDakshina, Kannada- 574202          | AYUSH - 64               |
|       2 | Punjab           | i. M/s Dhanwantri Herbals, Amritsar                                                                                    | AYUSH - 64               |
|       2 | Punjab           | ii. M/s IMPCL C/o ShriDhanwantri Herbal, Amritsar (Loan License)                                                       | AYUSH - 64               |
|       2 | Punjab           | iii. M/s PrabharAyurvedic Pharmacy, Amritsar                                                                           | AYUSH - 64               |
|       2 | Punjab           | iv. M/s Shri KrishnaAyurvedic Herbal, Amritsar                                                                         | AYUSH - 64               |
|       2 | Punjab           | v. M/s Curoveda Herbal, Amritsar                                                                                       | AYUSH - 64               |
|       2 | Punjab           | vi. M/s Caulis Healthcare, Ludhiana                                                                                    | AYUSH - 64               |
|       2 | Punjab           | vii. M/s Arogya Pharmacy, Mansa                                                                                        | AYUSH - 64               |
|       3 | Kerala           | i. M/s Dhathri Ayurveda Pvt. Door No. MP 46/3578, Adappilly road, Vennala, P.O. Ernakulam District - 682028, Kerala    | Ltd. AYUSH - 64          |
|       3 | Kerala           | ii. M/s The Pharmaceutical Corporation (IM) Kerala (Oushadhi), Door No. IX/590 599,Kuttanellur, Thrissur District.     | Ltd to AYUSH - 64        |
|       3 | Kerala           | iii. M/s. Bipha Drug Laboratories Ltd., Door No. B1, B2, B3, Industrial Estate, Ettumanoor, Kottayam District, Kerala. | Pvt. B4, AYUSH - 64      |
|       4 | Himachal Pradesh | i. M/s Tirupati Medicare Ltd., Road, Poanta Sahib, Distt. Sirmour, H.P.                                                | Nahan AYUSH - 64 Tablet  |
|       4 | Himachal Pradesh | ii. M/s Sarvotham Care, village Jharmajri, Barotiwala -BaddiR|oad, Tehsil - Baddi, Distt. Solan, H.P.             | AYUSH - 64 Tablet        |
|       4 | Himachal Pradesh | iii. M/s Baijnath Pharmaceuticals Ltd. PO Paprola, Tehsil - Baijnath, Distt. Kangara, H.P.                             | Pvt. AYUSH - 64 Tablet   |
|       5 | Uttarakhand      | i. M/s Indian Medicine Pharmaceuticals Corporation                                                                     | AYUSH - 64 Tablet        |

|    |            | Ltd. (IMPCL), Unit -II, Khasra No. 673, Imlikhera, Haridwar                                             | Roorke,                              |
|----|------------|---------------------------------------------------------------------------------------------------------|--------------------------------------|
|    |            | ii. M/s SrivedaSattvaPvt. Plot no. 13 & 14, Sigaddi Growth Centre, Kotdwar, Garhwal                     | Ltd. Pori AYUSH - 64 Tablet          |
|    |            | iii. M/s Indian Medicine Pharmaceuticals Corporation Ltd. (IMPCL), Mohan Almora                         | AYUSH - 64 Tablet                    |
|    |            | iv. M/s Multani Pharmaceuticals Ltd., Khasra No. 37, Village - Makkanpur, Bhagwanpur, Roorkee, Haridwar | AYUSH - 64 Tablet                    |
|    |            | v. M/s DeshrakshakAushdhalaya Ltd., BhagwantKut i, Kankhal, Haridwar                                    | AYUSH - 64 Tablet                    |
|    |            | vi. M/s HLL Lifecare Ltd. No. 98. Khasra No. Village - Makkanpur, Bhagwanpur, Roorkee, Haridwar         | Khata 37, AYUSH - 64 Tablet          |
|    |            | vii. M/s Maheswari Pharmaceuticals(India) Plot no.7, Sector - 6B, IIE, Haridwar                         | Ltd., AYUSH - 64 Tablet              |
|    |            | viii. M/s Karnani Pharmaceuticals Pvt. Ltd, 38, Pharmacity, Selakui, Dehradun                           | AYUSH - 64 Tablet                    |
| 6. | Tamil Nadu | M/s Ancient Pharma, Madurai                                                                             | Plasmodin( AYUSH - 64)               |
| 7. | Rajasthan  | i.Karnani Pharmaceuticals Pvt. F-67 Industrial area Bhiwadi, Rajasthan - 301019                         | Ltd., CORO - STOP (AYUSH -64) TABLET |

## Annexure - II I STEPS INVOLVED IN TECHNOLOGY TRANSFER AND LICENSE APPROVAL

## FOR AYUSH-64

1. Central Council for Research in Ayurvedic Sciences (CCRAS) and National Research Development Corporation (NRDC) have an agreement for the purpose of commercial  exploitation  of  Technologies  and  Intellectual  Property  Rights  (IPR) generated  by  CCRAS,  including  AYUSH-64.  Further,  a  MoU  was  signed  on 3rd March, 2015, between both the parties for the purpose.
2. Manufacturing  companies  are  approaching  NRDC  for  technology  transfer  for manufacturing of AYUSH-64 on behalf of CCRAS.
3. After  transfer  of  technology  to  a  Manufacturer  by  NRDC,  CCRAS  provides  the manufacturer,  the  complete  Know-How  document  for  AYUSH-64  containing  all relevant  information,  required  for  production.  If  required  by  the  manufacturer, provision for training is also available. Also, to facilitate the Stake holders, CCRAS has  issued  a  Notification  dated  30.04.2021  for  commercialization  of  AYUSH-64 developed by CCRAS.
4. The  Manufacturers  after  technology  transfer  from  NRDC  alongwith  a  copy  of  the complete  Know-How  document  for  AYUSH-64  provided  by  CCRAS,apply  to  the respective SLA for obtaining license of the product.
5. In this regard, Ministry of AYUSH issued a Notification dated 27.4.2021 to All State Licensing  Authorities  (SLA's) to  allow  the  licensed  manufacturers  for  AYUSH-64 under their jurisdiction to include new indication of AYUSH 64 for repurposing as an intervention for the management of asymptomatic, mild to moderate COVID-19 in addition  to existing  indication(s)  and  also to  expedite  the  process  of  the licensing/approval  of  such  applications  for  the  manufacturing  of  AYUSH  64 medicine, provided the prescribed standards and relevant provisions of the Drugs & Cosmetics Rules, 1945, are fulfilled.