Lok Sabha Question No. 3902 (UNSTARRED), answered on 2022-03-25
Subject: License for Manufacturing of AYUSH-64
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: R.K. Singh Patel

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 3902 TO BE ANSWERED ON 25 th  March, 2022

## LICENSE FOR MANUFACTURING OF AYUSH-64

## 3902. SHRI R.K. SINGH PATEL:

Will the Minister of AYUSH be pleased to state:

(a) the number of companies that came forward to obtain license for manufacturing AYUSH-64, state-wise;

(b) whether there is any possibility of the transfer of technology to such companies through the Central  Council  for  Research  in  Ayurvedic  Sciences  (CCRAS)  and  National  Research  and Development Center (NRDC);

(c) if so, whether the Central Council for Research in Ayurvedic Sciences (CCRAS) is likely to provide technical assistance in the manufacturing of AYUSH-64  to medicine manufacturers; and (d) if so, the details thereof?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

- (a) The  technology  of  AYUSH-64  was  transferred  to  the  interested  manufacturers  through  an agreement  between  National  Research  Development  Corporation  (NRDC)  and  Central Council for Research in Ayurvedic Sciences (CCRAS). The list of 46 manufacturers to whom the  technology  of  AYUSH-64  is  transferred  by  the  concerned  agencies  is  placed  at Annexure-I .  The manufacturers after technology transfer obtain license of the product from the concerned State Drug Licensing Authority (SLA). The details of approvals given to such companies by respective SLAs for manufacturing of AYUSH-64 are placed at Annexure-II.
- (b) Yes, the details and the procedure are annexed at Annexure III .

(c) Yes, Sir.

- (d) After technology transfer to a manufacturer by NRDC and CCRAS, the complete know-how document  of  AYUSH-64  containing  all  relevant  information  required  for  production  is provided to the manufacturer. 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.

## Annexure-I

## LIST OF MANUFACTURING UNITS TO WHICH AYUSH-64 TECHNOLOGY HAS BEEN TRANSFERRED

|   Sl. No. | Name of the Company                                                                                                                           | State/UT         |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------|------------------|
|         1 | M/s Indian Medicines Pharmaceuticals Co. Ltd. (IMPCL), Mohan, Ramnagar, Distt. Almora                                                         | Uttarakhand      |
|         2 | M/s Multani Pharmaceuticals Ltd. , New Delhi.                                                                                                 | NCT of Delhi     |
|         3 | M/s Upkaran Pharmaceuticals , Shop No. 25, Board Office Square, Zone-II, MaharanaPratap Nagar, Bhopal, Madhya Pradesh 462011                  | Madhya Pradesh   |
|         4 | M/s Dabur India Pvt. Ltd. , Sahibabad, Ghaziabad                                                                                              | Uttar Pradesh    |
|         5 | M/s Jamna Herbal Research Limited , 15, Zone-II, MaharanaPratap Nagar, Bhopal                                                                 | Madhya Pradesh   |
|         6 | Uttarakhand State Medicine& Pharmaceuticals Ltd., Haldwani, U.K.                                                                              | Uttarakhand      |
|         7 | M/s Sarvotham Care Limited, 197, Nicholson Road, Tadbund, Secunderabad, Telangana-500009                                                      | Telangana        |
|         8 | M/s Dindayal Industries Ltd. , 5-6, Industrial Estate, Tansen Road, Birla Nagar, Gwalior- 474004, M.P.                                        | Madhya Pradesh   |
|         9 | M/s Dhootpapeshwar Ltd ., Veer SavarkarChowk, Panvel, Raigad-410206, Maharashtra                                                              | Maharashtra      |
|        10 | M/s Dhatri Ayurveda Pvt. Ltd .,33/1882B, Adappilly Road, Ernakulum, Kerala                                                                    | Kerala           |
|        11 | M/s Tirupati Medicare Ltd ., Paonta Sahib, Distt. Sirmour, H.P.                                                                               | Himachal Pradesh |
|        12 | M/s SrivedaSattva Private Ltd ., Third Floor, No. 54/46, 39 th A Cross, 11 th Main Road, 4 th T Block, Jayanagar, Bangalore, Karnataka-560041 | Karnataka        |
|        13 | M/s Revinto Life Science Pvt. Ltd, Plot No. 21, KIDAB Industrial Area, Shirwada, Karwar, Uttara Kannada District, Karnataka- 581306           | Karnataka        |

|   Sl. No. | Name of the Company                                                                                                                | State/UT             |
|-----------|------------------------------------------------------------------------------------------------------------------------------------|----------------------|
|        14 | M/sKarnani Pharmaceuticals Pvt Ltd. 19/23,Vithoba Lane, Vithalwadi, Mumbai, Maharashtra- 400002                                    | Maharashtra          |
|        15 | OMPharmaceuticals Ltd., 202, Vishwa Nanak Apartments, GurunanakWadi, Chakala, Andheri (East), Mumbai, Maharashtra- 400099          | Maharashtra          |
|        16 | Karnataka Antibiotics &Pharmaceuticals Ltd ., Dr.Rajakumar Road, First Block, Rajajinagar, Bangalore-560010                        | Karnataka            |
|        17 | M/s DeshRakshakAushdhalya Ltd ., Kankhal, Haridwar-249408                                                                          | Uttarakhand          |
|        18 | M/s S.D.P. Remedies and Research Centre , Business Office at Udayagiri, Korungu, Kemminje, Village Puttur, DK, Karnataka- 574202   | Karnataka            |
|        19 | M/s MeghdootGramodyogSewaSansthan , A1/18, Sector- H, PuraniyaChauraha, Aliganj, Lucknow , U.P.                                    | Uttar Pradesh        |
|        20 | M/s Amulya Labs Private Ltd. , Plot No 74, Industrial Estate HSIIDC, Alipur, Barwala, Panchkula, Haryana- 134118                   | Haryana              |
|        21 | M/s Uma Ayurvedics Private Ltd ., MadhavPuri, Nadrai Gate, Kasganj (Etah), - 207123, U.P.                                          | Uttar Pradesh        |
|        22 | M/s Basic Ayurveda 46, Anand Industrial Estate, Mohan Nagar, Ghaziabad- 201007, U.P.                                               | Uttar Pradesh        |
|        23 | M/s Alna Biotech Pvt. Ltd. SCF 1013, Ground Floor Motor Market, Manimajra, Chandigarh-160101                                       | Haryana jurisdiction |
|        24 | M/s Pharmaveda (India) Private Ltd. B-4 Kamdar Shopping Centre, Opp Railway Station Vile Parle (East), Mumbai, Maharashtra- 400057 | Maharashtra          |

|   Sl. No. | Name of the Company                                                                                                    | State/UT         |
|-----------|------------------------------------------------------------------------------------------------------------------------|------------------|
|        25 | M/s Pharmaceutical Corporation (IM) Kerala Ltd. Kuttanellur P.O., Trissur, Kerala-680014                               | Kerala           |
|        26 | M/s Amar Pharmaceuticals and Labs (India) Pvt. Ltd. 17/110 NawabCompound,RamNarain Bazar, Kanpur, Uttar Pradesh-208001 | Uttar Pradesh    |
|        27 | M/s Shree Dhanwantri Herbals, Village Kishanpura, Tehsil Nalagarh, District Solan, Himachal Pradesh-174101             | Himachal Pradesh |
|        28 | M/s Maheshwari Pharmaceuticals (India) Ltd. , Plot No. 7, Sector 6B IIE SIDCUL, Haridwar,Uttarakhand-249403            | Uttarakhand      |
|        29 | M/s HLL Lifecare Limited HLL Bhavan, Mahilamandiram Road, Poojappura, Thiruvananthapuram, Kerala- 69                   | Kerala           |
|        30 | M/s Bipha Drug Laboratories Private Ltd . XIII/804, Pallipurathukavu Junction, Kottayam, Kerala- 686039                | Kerala           |
|        31 | M/s Himalaya Research Laboratory, EPIP, Bari Brahmna, Jammu-181133                                                     | J&K              |
|        32 | M/s Mangalam Biotech Research 39/23, 2nd Floor, Lane No. 15, Sameyapur Industrial Area, Delhi-110042                   | Delhi            |
|        33 | M/s North India Life Sciences Private Limited Plot No-430, Sec-3, HSIIDC Karnal, Haryana- 132001                       | Haryana          |
|        34 | M/s Nirav Healthcare, Plot No. 25, GIDC Phase-I, Industrial Estate, Rajpipla, Narmada, Gujarat-393145                  | Gujarat          |

|   Sl. No. | Name of the Company                                                                                                     | State/UT         |
|-----------|-------------------------------------------------------------------------------------------------------------------------|------------------|
|        35 | M/s Minor Forest Produce Processing& Research Centre, Van Parisar, Barkheda, Pathani, Bhopal-462021                     | Madhya Pradesh   |
|        36 | M/s Multi State Cooperative Pharmaceuticals &Research, Lane No. 1, MangalParao, Haldwani, Nainital -263139, Uttarakhand | Uttarakhand      |
|        37 | Co-operative Drug Factory Udyog Nagar, Ganiadeoli, Ranikhet, Almora, Uttarakhand- 263645                                | Uttarakhand      |
|        38 | M/s Baijnath Pharmaceuticals Pvt Ltd., P.O. Paprola, Tehsil Baijnath, Distt. Kangra, Himachal Pradesh-176115            | Himachal Pradesh |
|        39 | M/ s Rajasthan Herbal International Pvt Ltd., F- 143, IInd Phase, Riico Industrial Area, Jhunjhunu, Rajasthan- 333001   | Rajasthan        |
|        40 | M/ s Nagarjun Pharmaceuticals Pvt Ltd. Sherisa, Kalol-Khatraj Road, Kalol, Gandhinagar, Ahmedabad, Gujarat- 382721      | Gujarat          |
|        41 | M/s Hamdard Laboratories (India)- Medicine Division, Hamdard Building, 2A/3 Asaf Ali Road, New Delhi-110002             | New Delhi        |
|        42 | M/s Royal Bee Natural Products Pvt. Ltd., S-16Loni Road, Site-2, Mohan Nagar, Ghaziabad- 206002 U.P.                    | Ghaziabad        |
|        43 | Aayukart Private Ltd., H1-2213, RIICO Industrial Area, Ramchandrapura, Sitapura Extension, Jaipur, Rajasthan- 302022    | Jaipur           |
|        44 | M/s Goa Antibiotics &Pharmaceuticals Ltd., Tuem Industrial Area, Tuem, Pernem, Goa-403512                               | Goa              |
|        45 | M/s Zeon Life Sciences Ltd., Village Kunja, Rampur Road, Paonta Sahib, Himachal Pradesh- 173025                         | Himachal Pradesh |
|        46 | M/s Haritha Pharmaceuticals, Building No. 332, Vadakkumuri, Varandarappilly, Thrissur, Kerala- 680303                   | Kerala           |

## 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. Ltd, Plot No.21, KIDAB Industrial Area, Shirwad, Karwar- 581301                              | 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 Krishna Ayurvedic 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. Ltd. Door No. MP 46/3578, Adappilly road, Vennala, P.O. Ernakulam District-682028, Kerala         | AYUSH-64          |
|       3 | Kerala           | ii. M/s The Pharmaceutical Corporation (IM) Kerala Ltd (Oushadhi), Door No. IX/590 to 599,Kuttanellur, Thrissur District.      | AYUSH-64          |
|       3 | Kerala           | iii.M/s. Bipha Drug Laboratories Pvt. Ltd., Door No. B1, B2, B3, B4, Industrial Estate, Ettumanoor, Kottayam District, Kerala. | AYUSH-64          |
|       4 | Himachal Pradesh | i. M/s Tirupati Medicare Ltd., Nahan Road, Poanta Sahib, Distt. Sirmour, H.P.                                                  | 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 Pvt. Ltd. PO Paprola, Tehsil- Baijnath, Distt. Kangara, H.P.                                 | AYUSH-64 Tablet   |

|   S.No. | State/UT    | Company Name                                                                                                          | Brand Name                   |
|---------|-------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------|
|       5 | Uttarakhand | i. M/s Indian Medicine Pharmaceuticals Corporation Ltd. (IMPCL), Unit-II, Khasra No. 673, Imlikhera, Roorke, Haridwar | AYUSH-64 Tablet              |
|       5 | Uttarakhand | ii. M/s SrivedaSattvaPvt. Ltd. Plot no. 13 & 14, Sigaddi Growth Centre, Kotdwar, Pori Garhwal                         | AYUSH-64 Tablet              |
|       5 | Uttarakhand | iii. M/s Indian Medicine Pharmaceuticals Corporation Ltd. (IMPCL), Mohan Almora                                       | AYUSH-64 Tablet              |
|       5 | Uttarakhand | iv. M/s Multani Pharmaceuticals Ltd., Khasra No. 37, Village- Makkanpur, Bhagwanpur, Roorkee, Haridwar                | AYUSH-64 Tablet              |
|       5 | Uttarakhand | v. M/s DeshrakshakAushdhalaya Ltd., BhagwantKuti, Kankhal, Haridwar                                                   | AYUSH-64 Tablet              |
|       5 | Uttarakhand | vi. M/s HLL Lifecare Ltd. Khata No. 98. Khasra No. 37, Village- Makkanpur, Bhagwanpur, Roorkee, Haridwar              | AYUSH-64 Tablet              |
|       5 | Uttarakhand | vii. M/s Maheswari Pharmaceuticals(India) Ltd., Plot no.7, Sector- 6B, IIE, Haridwar                                  | AYUSH-64 Tablet              |
|       5 | Uttarakhand | 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. Ltd., F-67 Industrial area Bhiwadi, Rajasthan-301019                                  | CORO-STOP (AYUSH- 64) TABLET |

## 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.

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