Lok Sabha Question No. 4524 (UNSTARRED), answered on 2016-08-12
Subject: Clinical Trials of Traditional Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: CHARANJEET SINGH RORI, RENUKA BUTTA

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

LOK  SABHA UNST ARRED QUESTION NO.4524 TO BE ANSWERED ON 12 TH AUGUST, 2016

## CLINICAL TRIALS OF T RADITIONAL MEDICINES

## 4524. SHRI CHARANJEET SINGH RORI:

## SHRIMATI BUTTA RENUKA:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a) whether the Government has permitted clinical trials of traditional medicines and i so, the details thereof;
- (b) whether the Government proposes to revise the guidelines on clinical trials for new drugs including Ayurveda and if so, the details thereof; and
- c) the time by which the revised guidelines on clinical trials for new AYUSH drugs are lik be implemented?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO NAIK)

- ( a) : Drugs & Cosmetics Act, 1940 and Rules thereunder do not have any provisions fo clinical  trials  on  traditional  medicines.  However,  on  receipt  of  clinical  trial  pro Ayurvedic  and  herbal  medicines,  the  then  Department  of  AYUSH  granted  permission  to ten institutes for conducting clinical trials during the period April, 2008 to September, details of these clinical trials are annexed.
- ( b) & ( c) : New AYUSH drugs including Ayurveda are not defined in the provisions of the Drugs & Cosmetics Act, 1940 and Rules thereunder. The Government published 'Good Clinical Practice Guidelines for Clinical Trials in Ayurveda, Siddha and Unani Medicine (GCP -ASU)' in the year 2013 with the objective that the studies are scientifically and ethical ly sound and the clinical  properties  of  the  ASU  medicines  under  investigation  are  properly  documented. guidelines do not have any legal binding to conduct the clinical trials and no proposal consideration to revise them.

………………

Permission granted to the Institutes for conducting Clinical Trials

|   S No. | Name of the Institution                                                                                                                                        | Subject of Clinical Trial                                                                                                                                                                   |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Indian Institute of Integrative (IIIM), Jammu:                                                                                                                 | Medicine Proof of Safety and Efficacy Trials on Health Promoter Formulations based on Plants.                                                                                               |
|       2 | M/s Arvind Remedies and Ramachandra University, Chennai:                                                                                                       | Sri Porur, Multicentric Clinical Trial of Herbal for Management of Cardiovascul ar and Neurologic Disorders.                                                                                |
|       3 | Institute of Medical Sciences, Hindu University and SASTRA University, Thanjavur:                                                                              | Banaras Multicentric Clinical Trial for Management of Metabolic Syndrome - an Ayurvedic Intervention.                                                                                       |
|       4 | Institute of Medical Sciences, Hindu University and SASTRA University, Thanjavur                                                                               | Banaras Prevention and Management of and Cardiovascular Complications Menopausal Women.                                                                                                     |
|       5 | St. Johns Medical College Bangalore.                                                                                                                           | Hospital, Clinical Trial of Coded Ayurvedic Drug QOL - 2C.                                                                                                                                  |
|       6 | Institute of Medical Sciences, Hindu University & M/s Baijnath Pharmaceuticals, Paprola, Distt. Himachal Pradesh.                                              | Banaras Kangra, Multicentric Clinical Trial in Management of Type -II Diabetes mellitus associated vascular complications by a - herbal formulation.                                        |
|       7 | National Iinstitute of Mental Neuro Sciences, Bangalore; Dr. Hospital, New Delhi and BHU, Varanasi                                                             | Health and RML Clinical trial for effect of Ayurvedic - Ayushmanas in the management of Manasmandata (Mental Retardation).                                                                  |
|       8 | Interdisciplinary School of System of Medicine, SRM University, Kancheepuram, Tamil Nadu & Institute of Medical Sciences, Banaras Hindu University, Varanasi   | Indian Clinical trial on a Herbal formulation Prevention and Management of Coronary Disease.                                                                                                |
|       9 | Interdisciplinary School of System of Medicine, SRM University, Tamil Nadu & Institute of Sciences Banaras Hindu University, Varanasi                          | Indian Medical Multicentric Clinical Trial on Herbal in the Prevention and Management of Age - related Neurodegenerative Disorders with special Senile Dementia of Alzheimer's Type (SDAT). |
|      10 | Interdisciplinary School of System of Medicine, SRM University, K ancheepuram, Tamil Nadu & Institute of Medical Sciences, Banaras Hindu University, Varanasi. | Indian Management of Neuropsychitric Cardiovascular Complications among Women.                                                                                                              |

## Annexure

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