Lok Sabha Question No. 52 (STARRED), answered on 2022-12-09
Subject: Research on New Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Bholanath (B.P. Saroj)

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA STARRED QUESTION NO. *52 TO BE ANSWERED ON 09.12.2022

## RESEARCH ON NEW AYURVEDIC MEDICINES

## * 52.     SHRI  BHOLANATH (B.P. SAROJ)

Will the Minister of Ayush be pleased to state:

- (a) whether the Government has initiated adequate measures for conduct of research on the development of new Ayurvedic Medicines and Clinical Trials through Government controlled laboratories for critical ailments;
- (b) if so, the details thereof including the diseases for which effective medicines have been developed during the last three years;
- (c) whether clinical trials have confirmed the effectiveness of these medicines before their introduction in the market; and
- (d) if so, the detail thereof including the steps taken by the Government?

## ANSWER

THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

- (a) to (d):   A statement is laid on the Table of the  House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 52 FOR 9 TH  DECEMBER, 2022

*****

(a) Yes, Sir.

(b) The Central  Council  for  Research  in  Ayurvedic  Sciences  (CCRAS),  an  Autonomous Body  under  Ministry of Ayush  has developed various Ayurvedic drugs through  Drug Development  process.  Drug  development  is  a  continuous  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. 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, ATT induced Hepatotoxicity, Non-alcoholic fatty liver diseases, Antenatal Care (Anemia), Antenatal Care (Oedema), Malaria / Mild to Moderate COVID - 19. The details of  some important drugs developed by CCRAS and drugs under development by CCRAS are given at Annexure -I & II.

(c)&(d) Yes,  Sir.  The  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 pre-clinical 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  ASU  drugs (GCP-ASU), Ministry of AYUSH and Ethical guidelines for Bio-Medical Research (ICMR) and WHO guidelines for traditional medicines etc. as per requirement and introduced in the market after ascertaining the effectiveness and safety.

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## Annexure-I

## List of some important drugs developed by CCRAS since inception

|   S. No. | Name of the Drug           | Indication                                                |
|----------|----------------------------|-----------------------------------------------------------|
|        1 | AYUSH -64                  | Malaria / 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                                            |

## Drugs under development by CCRAS during last three years

| Name of the Drugs under Drug Standardization   | Name of the drugs under pre clinical safety toxicity study   | Name of the drugs 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                                    | 4. AYUSH-SC-3                                                | 4. Ayush - PTK - ATT induced Hepatotoxicity         | 4. Ayush - PE Eye Drops - Conjunctivitis                            |
| 5. AYUSH-SG                                    | 5. AYUSH-SS granules ,                                       | 5. Ayush - GMH - Non alcoholic fatty liver diseases | 5. Ayush - Carctol - Cancer(completed phase 1)                      |
| 6. AYUSH Ghutti                                | 6. AYUSH-LND ,                                               | 6. Ayush - HR - Pre Hypertension                    | 6. Ayush - D - Pre Diabetes and Diabetes                            |
| 7. AYUSH KVM Syrup                             | 7. AYUSH-64                                                  | 7. Ayush - AGT - Wound healing                      | 7. Ayush - SL - Filariasis                                          |
| 8. AYUSH - M3                                  | 8. AYUSH SG-5                                                | 8. C-1 oil for Wound healing                        | 8. Ayush - 64 (Repurposing) - Malaria / Mild to Moderate Covid - 19 |
| 9. AYUSH-SS Granules                           | 9. AYUSH-V13                                                 | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 10. AYUSH-SC3                                  | 10. AYUSH V-24                                               | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 11. AYUSH-SR                                   | 11. Padmakanta Yoga,                                         | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 12. AYUSH-PTK                                  | 12. AYUSH-PTK & AYUSH-GMH                                    | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 13. AYUSH-GMH                                  | 13. Carctol-S                                                | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 14. AYUSH-PVK Gel                              | 14. CARAF & CAGHE                                            | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 15. AYUSH- NT Capsule                          | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 16. AYUSH - LK Gel                             | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 17. AYUSH - SL                                 | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 18. AYUSH-D                                    | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 19. AYUSH-Carctols                             | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 20. AYUSH-CCT                                  | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 21. AYUSH-82                                   | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |
| 22. AYUSH-AGT                                  | 15. Ayush Manas                                              | 8. C-1 oil for Wound healing                        | 9. Ayush - AGT - Dandruff                                           |

## Annexure-II