Lok Sabha Question No. 2241 (UNSTARRED), answered on 2023-12-15
Subject: Research on Ayurvedic Medicines and Clinical Trials
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Rajan Baburao  Vichare

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA

## UNSTARRED QUESTION NO. 2241 TO BE ANSWERED ON 15 th  December, 2023

"Research on Ayurvedic Medicines and Clinical Trials"

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## 2241. SHRI RAJAN VICHARE:

Will the Minister of AYUSH be pleased to state:

- a) whether the Government has initiated adequate measures for conducting research on the development of new Ayurvedic Medicines and Clinical Trials through Government controlled laboratories for critical ailments;
- b) if  so,  the  details  thereof  along with the diseases  for which effective medicines have been developed during the last three years and the current year;
- c) whether  such  clinical  trials  have  confirmed  the  effectiveness  of  these  medicines before their introduction in the market;
- d) if so, the details thereof; and
- e) if not, the steps taken/proposed to be taken by the Government in this regard?

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

(a) Yes, Sir. The Ministry of Ayush, has setup Central Council for Research in Ayurvedic Sciences (CCRAS) for undertaking coordinating formulating, developing and promoting research  on  scientific  lines  in  Ayurveda.  The  activities  are  carried  out  through  30 institute/Centres/Units located all over India and also through collaborative studies with various universities, hospitals and institutes. The research activities of the Council include medicinal  plant  research  (Medico-ethno  botanical  survey,  pharmacognosy  and  tissue culture),  Drug  Standardization,  Pharmacological  Research,  Clinical  Research,  Literary Research & Documentation and other outreach activities.

The Central Council for Research in Ayurvedic Sciences is conducting Clinical trials for validation of Classical  Ayurvedic  formulations  and  also  for  new  Ayurvedic  drug development adopting prevalent guidelines such as Good Clinical Practices Guidelines for ASU  drugs  (GCP-ASU),  Ministry  of  Ayush  and  Ethical  guidelines  for  Bio-Medical Research (ICMR), WHO guidelines for traditional medicines etc. as per requirement.

Since inception the Council has developed various Ayurvedic drugs through Drug Development process. Drug development is a continues process and takes around 5-7 years through  various  stages  like  standardization  of  ingredients  /  formulations,  safety/  toxicity studies followed by clinical studies. Compilation of data and commercialization of the newly developed drug. The details are at Annexure 1

(b) In  the  past  three  years  CCRAS  is  in  process  of  developing  various  Ayurvedic formulations  for  diseases  like:      Dengue,  Migraine,  improving  quality  of  life  in  Cancer patients, Mental Retardation in Children, Geriatric Health, Conjunctivitis, Cancer, Diabetes, Asthma, Filariasis, Occupational Stress, Anti Tubercular Treatment (ATT) induced Hepatotoxicity, Non-alcoholic fatty liver diseases, Antenatal Care (Anemia), Antenatal Care (Oedema), Malaria / Mild to Moderate Covid - 19. Details are at Annexure-2

(c)  to  (e)  Yes,  Sir.  Central  Council  for  Research  in  Ayurvedic  Sciences  (CCRAS)   is conducting Clinical trials for validation of Classical Ayurvedic formulations and also for new Ayurvedic  drug  development  adopting  prevalent  guidelines  such    as  Good  Collection, Processing  and  Storage  Practices  for  collection  of  medicinal  plants  (raw  drugs),  Good Manufacturing Practices (GMP), Standard Operating Procedures for Formulation of quality drugs,  Carrying  out  preclinical  studies  as  per  Organisation  for  Economic  Cooperation  & Development (OECD) for raw drugs, Registration of clinical trials in Clinical Trial Registry of India (CTRI) of ICMR,  Good Clinical Practices Guidelines for Ayurveda, Siddha, Unani drugs  (GCP-ASU),  Ministry  of  Ayush  and  Ethical  guidelines  for  Bio-Medical  Research (ICMR) and WHO guidelines for traditional medicines etc. as per requirement

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## Annexure -1

## 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                                            |

## Annexure-2

## Drugs under development by CCRAS during last three years

| 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. Ayush PJ-7 - Dengue                                                    |
| 2. AYUSH - 56                                  | 2. Ayush-SDM tablet                                             | 2. Ayush - A - Asthma                               | 2. Ayush QOL-2C - Quality of life in Cancer patients                      |
| 3. AYUSH-HR                                    | 3. Ayush-PK Avaleha                                             | 3. Ayush - SR - Occupational Stress                 | 3. Ayush Rasayan A&B - Geriatric Health                                   |
| 4. AYUSH-64                                    | 3. Ayush-PK Avaleha                                             | 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       | 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       | 9. Ayush - AGT - Dandruff                                                 |
| 10. AYUSH-SC3                                  | 9. AYUSH V-24                                                   | Cancer                                              | 9. Ayush - AGT - Dandruff                                                 |
| 11. AYUSH-SR                                   | 10. Padmakanta Yoga                                             | 10. Ayush Manas- Cognitive Deficit                  | 10. Ayush - AGT - Wound healing                                           |
| 12. AYUSH-PTK 13. AYUSH-GMH                    | 11. Ayush-PTK                                                   | 10. Ayush Manas- Cognitive Deficit                  | 11.Ayush CCT - postoperative cardiac care                                 |
| 14. AYUSH-PVK Gel                              | 10. Padmakanta Yoga                                             | 10. Ayush Manas- Cognitive Deficit                  | 12. Ayush SS granules - Lacatation insufficiency                          |
| 15. AYUSH- NT                                  | 10. Padmakanta Yoga                                             | 10. Ayush Manas- Cognitive Deficit                  | 12. Ayush SS granules - Lacatation insufficiency                          |

| Capsule             | 13.Ayush LND - Abnormal Uterine Bleeding (AUB)   |
|---------------------|--------------------------------------------------|
| 16. AYUSH - LK Gel  |                                                  |
| 17. AYUSH - SL      |                                                  |
| 18. AYUSH-D         |                                                  |
| 15. AYUSH- Carctols | 14. Ayush PVK gel - Shweta Pradara(Leucorrh      |
| 16. AYUSH-CCT       | oea)                                             |
| 17. AYUSH-82        |                                                  |
|                     | Capsule-Psoriasis                                |
| 18. AYUSH-AGT       |                                                  |

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