Lok Sabha Question No. 31 (UNSTARRED), answered on 2024-02-02
Subject: Indigenous Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Sanjay Haribhau Jadhav, Vinayak Bhaurao Raut

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 31 TO BE ANSWERED ON 02 nd  February, 2024

## 'Indigenous Medicines'

## 31.   SHRI SANJAY JADHAV: SHRI VINAYAK RAUT:

- (a) the details of the indigenous medicines pending approval during the last five years and the current  year  along  with  the  names  of  said  medicines  and  the  diseases  for  which  the  said medicines are effective;
- (b) whether the applications regarding several medicines are pending with the Government for a long time;
- (c) if so, the details thereof along with the reasons therefor;
- (d)  the  list  of  AYUSH  medicines approved, disapproved and pending approval during the last five years and the current year;
- (e) the details of the researches/experiments conducted to invent new medicines; and
- (f)  the  details  of  the  AYUSH  drug  testing  centres  in  the  country,  State/UT-wise  and  locationwise?

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

(a)  to    (c)  As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made  thereunder, enforcement of the legal provisions pertaining to Quality Control and issuance of drug license of Ayurveda, Siddha,  Unani and Homoeopathy drugs, is vested with the State Drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines and Rule 85 (A to I) in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Homoeopathy  medicines.  It  is  mandatory  for  the  manufacturers  to  adhere  to  the  prescribed requirements  for  licensing  of  manufacturing  units  &  medicines  including  proof  of  safety  & effectiveness, compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

As per the information received from State/UT government, the details of the indigenous medicines pending for approval during the last five years and the current year are at Annexure I.

(d)  Central  Council  for  Research  in  Homoeopathy  (CCRH)  under  Ministry  of  Ayush  has approved 03 new indigenous drugs i.e. Coleus forskohlii, Catharanthus roseus and Adansonia digitata during the last five years.

As  per  the  information  received  from  State/UT  government,  the  details  of  medicines approved, disapproved and pending approval during the last five years and the current year are at Annexure-II.

(e) Central Council for Research in Ayurvedic Sciences (CCRAS) under Ministry of Ayush has undertaken  research  for  development  of  Ayurvedic  drugs  through  systematic  process  of  Drug Development  viz.  standardization,  quality  control,  safety/  toxicity  studies  and  clinical  studies adopting prevalent guidelines in vogue as per requirement. Details are at Annexure III.

Central Council for Research in Unani Medicines (CCRUM) under Ministry of Ayush has conducted various researches to invent new medicine/ technique. Based on the innovations, CCRUM has got 18 patents from the Indian Patent Office.

Central  Council  for  Research  in  Homoeopathy  (CCRH)  under  Ministry  of  Ayush  has conducted homoeopathic pathogenetic trials/ Drug proving trials to determine the pathogenetic effects of 03 new drugs i.e. Coleus forskohlii, Catharanthus roseus and Adansonia digitata.

(f) Pharmacopoeia Commission of Indian Medicine & Homoeopathy (PCIM&H), Ghaziabad, a sub-ordinate  office  under  Ministry  of  Ayush,  acts  as  Central  Drug  Testing  cum  Appellate Laboratory for testing of Ayurveda, Siddha, Unania and Homoeopathy drugs.

Rule  160  A  to  J  of  the  Drugs  and  Cosmetics  Rules,  1945  provides  the  regulatory guidelines for approval of Drug Testing Laboratory for carrying out such tests of identity, purity, quality  and  strength  of  Ayurvedic,  Siddha  and  Unani  drugs  as  may  be  required  under  the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs.  As  on  date,  34  State  Drug  Testing  Laboratories  have  been  supported  for  strengthening their infrastructural and functional capacity.  Further, 106 laboratories are approved or licensed under  the  provisions  of  Drugs  and  Cosmetics  Rules,  1945  for  quality  testing  of  Ayurvedic, Siddha and Unani drugs and raw materials. Details of the State Drug Testing Laboratories and Private Drug testing laboratories licensed   under the provisions of Drugs and Cosmetics Rules, 1945 are available at https://ayush.gov.in/images/domains/quality\_standards/StateDrugTestingLaboratoryASUHEng. and https://ayush.gov.in/images/domains/quality\_standards/ListofAyurvedaSiddhaUnani.pdf.

*******

## Annexure-I

Details of the indigenous medicines pending approval during the last five years and the current year are as follows -

|   S.no. | Name of the State/ UT   | Details of the indigenous medicines pending approval during the last five years and the current                  | Details of the indigenous medicines pending approval during the last five years and the current                  | Details of the indigenous medicines pending approval during the last five years and the current                  | Details of the indigenous medicines pending approval during the last five years and the current                  | Reasons                                                                                                          |
|---------|-------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
|       1 | Karnataka               | year Following 12 applications for product approval are pending since 02 years -                                 | year Following 12 applications for product approval are pending since 02 years -                                 | year Following 12 applications for product approval are pending since 02 years -                                 | year Following 12 applications for product approval are pending since 02 years -                                 | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | Sl. No.                                                                                                          | Name of the Medicine                                                                                             | Name of the Disease                                                                                              | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 1                                                                                                                | Charma Kleshari taila                                                                                            | Tvakroga                                                                                                         | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 2                                                                                                                | Kesha samruddini taila                                                                                           | keshiya                                                                                                          | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 3                                                                                                                | Madhu nivaran choorna                                                                                            | madhumeha                                                                                                        | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 4                                                                                                                | Tridosaha nivarana choorna                                                                                       | Tridosha prakopa                                                                                                 | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 5                                                                                                                | Vedana kleshari taila                                                                                            | Vedanahara                                                                                                       | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 6                                                                                                                | Swastharakshak lep                                                                                               | Tvaksnehi                                                                                                        | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 7                                                                                                                | Varam Herbals Hand Sanitizer liquid                                                                              | Krimihara                                                                                                        | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 8                                                                                                                | Varam Herbals disinfectant spray                                                                                 | Krimihara                                                                                                        | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 9                                                                                                                | Rise and Shine                                                                                                   | Madathyaa                                                                                                        | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 10                                                                                                               | Medohar tablet                                                                                                   | Medoroga                                                                                                         | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       1 | Karnataka               |                                                                                                                  | 11                                                                                                               | Immune Prime tablet                                                                                              | Rasayana                                                                                                         | 12 applications are pending due to non- submission of documents as per Rule 158B, 161B &169.                     |
|       2 | Maharashtra             | 35 applications are pending for more than one year. (as per information from fdamfg.maharashta.gov. in software) | 35 applications are pending for more than one year. (as per information from fdamfg.maharashta.gov. in software) | 35 applications are pending for more than one year. (as per information from fdamfg.maharashta.gov. in software) | 35 applications are pending for more than one year. (as per information from fdamfg.maharashta.gov. in software) | 35 applications are pending for more than one year. (as per information from fdamfg.maharashta.gov. in software) |
|       3 | Odisha                  |                                                                                                                  |                                                                                                                  |                                                                                                                  | NIL                                                                                                              |                                                                                                                  |
|       4 | Mizoram                 |                                                                                                                  |                                                                                                                  |                                                                                                                  | NIL                                                                                                              |                                                                                                                  |
|       5 | Delhi                   |                                                                                                                  |                                                                                                                  |                                                                                                                  | NIL                                                                                                              |                                                                                                                  |
|       6 | Tripura                 |                                                                                                                  |                                                                                                                  |                                                                                                                  | NIL                                                                                                              |                                                                                                                  |
|       7 | Arunachal               | Pradesh                                                                                                          | Pradesh                                                                                                          | Pradesh                                                                                                          | NIL                                                                                                              | Pradesh                                                                                                          |
|       8 | Uttarakhand             |                                                                                                                  |                                                                                                                  |                                                                                                                  | NIL                                                                                                              |                                                                                                                  |

|   9. | Jammu & Kashmir   | NIL   |
|------|-------------------|-------|
|   10 | Puducherry        | NIL   |
|   11 | Gujarat           | NIL   |
|   12 | Goa               | NIL   |
|   13 | Ladakh            | NIL   |
|   14 | Meghalaya         | NIL   |
|   15 | Uttar Pradesh     | NIL   |
|   16 | Himachal Pradesh  | NIL   |
|   17 | Andaman & Nicobar | NIL   |

Annexure-II State/UT-wise details of medicines approved, disapproved and pending for approval   -

|   S.no. | Name of the State/UT   | Details of medicines approved, disapproved and pending for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Details of medicines approved, disapproved and pending for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Details of medicines approved, disapproved and pending for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Details of medicines approved, disapproved and pending for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | Details of medicines approved, disapproved and pending for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|---------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Karnataka              | 4650 medicines has been approved, 88 medicines disapproved and 12 applications are pending.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 4650 medicines has been approved, 88 medicines disapproved and 12 applications are pending.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 4650 medicines has been approved, 88 medicines disapproved and 12 applications are pending.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 4650 medicines has been approved, 88 medicines disapproved and 12 applications are pending.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | 4650 medicines has been approved, 88 medicines disapproved and 12 applications are pending.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|       2 | Odisha                 | Year                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Ayurvedic medicines approved                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       | AYUSH medicines rejected/ disapproved                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | AYUSH medicines rejected/ disapproved                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | AYUSH medicines pending for approval                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|       2 | Odisha                 | 2020                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 152                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 10                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | 10                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       2 | Odisha                 | 2021                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 231                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 8                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 8                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       2 | Odisha                 | 2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 381                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | 1                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       2 | Odisha                 | 2023                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | 189                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       2 | Odisha                 | 2024                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       3 | Uttarakhand            |  In year 2018-19, approximately 2000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2019-20, approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In the year 2022-23 approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending. |  In year 2018-19, approximately 2000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2019-20, approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In the year 2022-23 approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending. |  In year 2018-19, approximately 2000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2019-20, approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In the year 2022-23 approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending. |  In year 2018-19, approximately 2000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2019-20, approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In the year 2022-23 approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending. |  In year 2018-19, approximately 2000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2019-20, approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2020-21, approximately 3000 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In year 2021-22, approximately 2500 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending.  In the year 2022-23 approximately 2700 Ayurvedic Patent & Proprietary Products approved, no medicine is disapproved and pending. |
|       4 | Uttar Pradesh          | No medicine is disapproved and pending for approval during the last five year and current year.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | No medicine is disapproved and pending for approval during the last five year and current year.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | No medicine is disapproved and pending for approval during the last five year and current year.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | No medicine is disapproved and pending for approval during the last five year and current year.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | No medicine is disapproved and pending for approval during the last five year and current year.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |
|       5 | Maharashtra            | From 2018 to till date, 36425 Ayush medicines approved, 4025 Ayush medicines disapproved/ rejected and 502 are pending. (as per information from fdamfg.maharashta.gov.in software)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | From 2018 to till date, 36425 Ayush medicines approved, 4025 Ayush medicines disapproved/ rejected and 502 are pending. (as per information from fdamfg.maharashta.gov.in software)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | From 2018 to till date, 36425 Ayush medicines approved, 4025 Ayush medicines disapproved/ rejected and 502 are pending. (as per information from fdamfg.maharashta.gov.in software)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | From 2018 to till date, 36425 Ayush medicines approved, 4025 Ayush medicines disapproved/ rejected and 502 are pending. (as per information from fdamfg.maharashta.gov.in software)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | From 2018 to till date, 36425 Ayush medicines approved, 4025 Ayush medicines disapproved/ rejected and 502 are pending. (as per information from fdamfg.maharashta.gov.in software)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       6 | Goa                    | Year                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Year                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               | Approved                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           | Disapproved                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Pending                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|       6 | Goa                    | 2018-19                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 2018-19                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 9                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       6 | Goa                    | 2019-20                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 2019-20                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 57                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       6 | Goa                    | 2020-21                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 2020-21                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | 45                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       6 | Goa                    | 2021-2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 2021-2022                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 36                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       6 | Goa                    | 2022-2023                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 2022-2023                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          | 16                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       6 | Goa                    | 2023-24 (till July)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 2023-24 (till July)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | 06                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       7 | Ladakh                 | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|       8 | Jammu &                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | NIL                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |

|    | Kashmir           |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |
|----|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|  9 | Arunachal Pradesh | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |
| 10 | Puducherry        | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |
| 11 | Tripura           | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |
| 12 | Delhi             | System                                                                                                                                                               | No. of classical medicine                                                                                                                                            | No. of classical medicine                                                                                                                                            | No. of classical medicine                                                                                                                                            | No. of Proprietary Medicine                                                                                                                                          | No. of Proprietary Medicine                                                                                                                                          | No. of Proprietary Medicine                                                                                                                                          |                                                                                                                                                                      |
| 12 | Delhi             | of                                                                                                                                                                   | Approved                                                                                                                                                             | Disapproved                                                                                                                                                          | Pending                                                                                                                                                              | Approved                                                                                                                                                             | Disapproved                                                                                                                                                          | Pending                                                                                                                                                              |                                                                                                                                                                      |
| 12 | Delhi             | Ayurveda                                                                                                                                                             | 1695                                                                                                                                                                 | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | 1862                                                                                                                                                                 | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |                                                                                                                                                                      |
| 12 | Delhi             | Unani                                                                                                                                                                | 2053                                                                                                                                                                 | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | 615                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |                                                                                                                                                                      |
| 13 | Himachal Pradesh  | Year Approved Disapproved/Rejected Pending 2021 755 80 NIL 2022 451 80 NIL 2023 886 108 NIL                                                                          |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |                                                                                                                                                                      |
| 14 | Mizoram           | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |
| 15 | Meghalaya         | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      | No manufacturing unit in the state of Meghalaya                                                                                                                      |
| 16 | Gujarat           | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. | No. of Ayurveda medicine applications approved from 1 st jan 2022 to till date are 7113, no. applications disapproved are 141 and no. of applications pending is 38. |
| 17 | Andaman & Nicobar | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  | NIL                                                                                                                                                                  |

## Details the researchers / experiments conducted by CCRAS to invent new medicines are as follows -

A. List of some important drugs developed by CCRAS since inception:

|   S. No. | Name of the Drug           | Indication                                                |
|----------|----------------------------|-----------------------------------------------------------|
|        1 | AYUSH -64                  | (i) Malaria (ii) Mild to moderate Covid-19                |
|        2 | AYUSH-56                   | Epilepsy                                                  |
|        3 | AYUSH-82                   | Diabetes Mellitus                                         |
|        4 | NIMBATIKTAM                | Psoriasis and Duodenal ulcer                              |
|        5 | AYUSH POSHAK YOGA AND PEYA | Immunomodulatory, Antistress and General Health Promotion |
|        6 | SHUNTHI GUGGULU            | Rheumatoid Arthritis (Amavata)                            |
|        7 | KSHARASUTRA                | Ano Rectal Disorders                                      |
|        8 | AYUSH BALARASAYANA         | Promotion of Health in Children                           |
|        9 | AYUSH GHUTTI               | Prevention of Diarrhoea and Fever in Children             |
|       10 | AYURVEDIC FORMULATIONS     | Antenatal Care                                            |

## B. Drugs under development by CCRAS

| Name of the Drugs under Drug Standardization   | Name of the drugs in under pre-clinical safety toxicity study   | Name of the drugs in under clinical study   | Name of the drug with completed Clinical study      |
|------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------|-----------------------------------------------------|
| 1. Ayush-Manas AYUSH-AG AYUSH - PG             | 1. Ayush-HR                                                     | 1. Ayush - M3 - Migraine and Hypertension   | 1. AyushPJ-7 - Dengue                               |
| 2. AYUSH - 56                                  | 2. Ayush-SDM tablet                                             | 2. Ayush - A - Asthma                       | 2. AyushQOL-2C - Quality of life in Cancer patients |
| 3. AYUSH-HR                                    | 3. Ayush-PK Avaleha                                             | 3. Ayush - SR - Occupational                | 3. Ayush Rasayan A&B - Geriatric Health             |

|                       |                      | Stress                                               |                                                                          |
|-----------------------|----------------------|------------------------------------------------------|--------------------------------------------------------------------------|
| 4. AYUSH-64           |                      | 4. Ayush - PTK - ATT induced Hepatotoxicity          | 4. Ayush - PE Eye Drops - Conjunctivitis                                 |
| 5. AYUSH-SG           | 4. Ayush-SS granules | 5. Ayush - GMH - Non alcoholic fatty liver diseases  | 5. C-1 oil for Wound healing                                             |
| 6. AYUSH Ghutti       | 5. Ayush-LND         | 6. Ayush - HR - Pre Hypertension                     | 6. Ayush - D - Pre Diabetes and Diabetes                                 |
| 7. AYUSH KVM Syrup    | 6. AYUSH-64          | 7. Ayush BR Leham in moderate malnutrition           | 7. Ayush - SL - Filariasis                                               |
| 8. AYUSH - M3         | 7. AYUSH SG-5        | 8. Ayush RP-Sickle Cell Anemia                       | 8. Ayush - 64 (Repurposing) -(i) Malaria (ii)Mild to Moderate Covid - 19 |
| 8. AYUSH - M3         | 7. AYUSH SG-5        | 9. Carctol S - Serologically relapsed Ovarian Cancer | 8. Ayush - 64 (Repurposing) -(i) Malaria (ii)Mild to Moderate Covid - 19 |
| 9. AYUSH-SS Granules  | 8. AYUSH-V13         | 9. Carctol S - Serologically relapsed Ovarian Cancer | 9. Ayush - AGT - Dandruff                                                |
| 10. AYUSH-SC3         | 9. AYUSH V-24        | 9. Carctol S - Serologically relapsed Ovarian Cancer | 9. Ayush - AGT - Dandruff                                                |
| 11. AYUSH-SR          | 10. Padmakanta Yoga  | 10. Ayush Manas- Cognitive Deficit                   | 10. Ayush - AGT - Wound healing                                          |
| 12. AYUSH-PTK         | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 11.Ayush CCT - postoperative cardiac care                                |
| 13. AYUSH-GMH         | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 11.Ayush CCT - postoperative cardiac care                                |
| 14. AYUSH-PVK Gel     | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 12. AyushSS granules - Lacatation insufficiency                          |
| 15. AYUSH- NT Capsule | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 13.Ayush LND - Abnormal Uterine Bleeding (AUB)                           |
| 16. AYUSH - LK Gel    | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   |                                                                          |
| 17. AYUSH - SL        | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   |                                                                          |
| 18. AYUSH-D           | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 14.Ayush PVK gel -Shweta Pradara (Leucorrhoea)                           |
| 19. AYUSH- Carctols   | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 14.Ayush PVK gel -Shweta Pradara (Leucorrhoea)                           |
| 20. AYUSH-CCT         | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 14.Ayush PVK gel -Shweta Pradara (Leucorrhoea)                           |
| 21. AYUSH-82          | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | 15.Ayush NT Capsule-                                                     |
| 22. AYUSH-AGT         | 11. Ayush-PTK        | 10. Ayush Manas- Cognitive Deficit                   | Psoriasis                                                                |