Lok Sabha Question No. 3117 (UNSTARRED), answered on 2015-08-07
Subject: Research and Clinical Trial of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: ANTO  ANTONY

**GOVERNMENT OF INDIA**

**MINISTRY OF AYURVEDA, YOGA & NATUROPATHY,**

**UNANI, SIDDHA AND HOMOEOPATHY**

**(AYUSH)**

**LOK  SABHA**

**UNSTARRED QUESTION NO. 3117**

**TO BE ANSWERED ON 7** **TH** **AUGUST, 2015**

**Research and Clinical Trial of AYUSH Medicines**

**3117. SHRI ANTO ANTONY:**

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

(a) whether the Drug Controller General of India (DCGI) is the overall authority to oversee research and clinical trial of different system of medical sciences including AYUSH in the country;

(b) if so, the details thereof;

(c) whether there has been any proposal to establish an independent statutory authority to oversee research and clinical trial in AYUSH including homoeopathy in the country; and

(d) if so, the details thereof and the action taken by the Government thereon?

Illegal vaccine trials

214. SHRI MOHD. ALI KHAN: Will

the Minister of HEALTH AND FAMILY

WELFARE be pleased to state:

(a) whether illegal vaccine trials are

taking place in the country; and

(b) if so, the details thereof and the action

taken against such trials and persons

responsible for such acts?

**ANSWER**

**THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,**

**YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY**

**(SHRI SHRIPAD YESSO NAIK)**

(a) & (b):   As per inputs received from the Drugs Division of the Ministry of Health & Family Welfare,  clinical trials as defined under Rule 122DAA of the Drugs and Cosmetics Rules, 1945 are regulated by the Drugs Controller General (India). The regulatory guidelines for issue of license based on the evidence of effectiveness and safety of various categories of Ayurveda, Siddha and Unani medicines are prescribed under Rule 158-B of the Drugs and Cosmetics Rules, 1945, which are enforced by the State Licensing Authorities. Ministry of AYUSH has also published Good Clinical Practice Guidelines for Clinical Trials in Ayurveda, Siddha and Unani Medicine.  In as far as research is concerned; AYUSH Research Councils have been established by the Government to oversee research activities including the clinical trials related to Ayurveda, Siddha, Unani, Yoga, Naturopathy and Homoeopathy.

(c) & (d): The Government has considered setting up a central regulatory regime for AYUSH medicines. In this regard, the current proposal is to have a vertical structure for AYUSH in the Central Drugs Standard Control Organization (CDSCO). Government has initiated procedural steps required for setting up the vertical structure of AYUSH in the CDSCO. As an interim arrangement Government has set up an Expert Committee headed by Deputy Drugs Controller to consider the clinical trial proposals of AYUSH for grant of permission.  For the purpose of research five Research Councils viz Central Council for Research in Ayurveda Sciences(CCRAS), Central Council for Research in Unani Medicines (CCRUM), Central Council for Research in Siddha (CCRS), Central Council for Research in Homoeopathy(CCRH) and Central Council for Research in Yoga and Naturopathy(CCRYN) are established by the Government to oversee research in AYUSH. These Research Councils have 81 units spread across the country, details given in the A nnexure.

**ANNEXURE**

1. **CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES**

| **S.No.**   | **Name of Institute**                                                                  |
|-------------|----------------------------------------------------------------------------------------|
|             | Ayurveda Central Research Institute, New Delhi                                         |
|             | National Research Institute  for  Panchakarma,  Cheruthuruthy                          |
|             | National Research Institute of Ayurvedic Drug Development, Bhubaneswar                 |
|             | National Research Institute of Ayurveda for Drug Development, Kolkata                  |
|             | National Institute of Ayurveda Pharmaceutical Research (NIAPR), Patiala                |
|             | National Veterinary – Ayurveda Research Institute and Hospital, Lucknow                |
|             | Raja RamdeoAnandilalPodar  Ayurveda Cancer Research Institute, Mumbai                  |
|             | Ayurveda Central Research Institute, Jaipur                                            |
|             | National Research Institute for Ayurveda- Siddha Human Resource Development, Gwalior   |
|             | National Ayurveda Research Institute for Vector Borne Diseases, Vijayawada             |
|             | Ayurveda Mental Health Research Institute, Nagpur                                      |
|             | National Ayurveda Dietetics Research Institute, Bengaluru                              |
|             | Ayurveda Research Institute for Mother and Child Health Care, Thiruvananthapuram       |
|             | Ayurveda Regional Research Institute, Patna                                            |
|             | North Eastern India  Ayurveda Research Institute, Guwahati                             |
|             | Ayurveda Regional Research Institute, Gangtok                                          |
|             | Ayurveda Regional Research Institute New Itanagar                                      |
|             | Ayurveda Regional Research Institute, Jammu                                            |
|             | Ayurveda Regional Research Institute, Mandi                                            |
|             | Ayurveda Contraceptive Drug Research Institute, Ahmedabad                              |
|             | Regional Research Institute of Himalayan Flora,  Tarikhet                              |
|             | National Vriksha Ayurveda Research Institute, Jhansi                                   |
|             | National  Research Institute of Basic Ayurvedic Sciences, Pune                         |
|             | National  Institute of Indian Medical Heritage, Hyderabad                              |
|             | Capt. Srinivasa Murthy Research Institute for Ay. and Siddha Drug Development, Chennai |
|             | Advanced Centre for Ayurveda in Mental Health and Neuro Sciences, Bengaluru            |
|             | Dr. AchantaLakshmipati Research Centre for Ayurveda, Chennai                           |
|             | Ayurveda Tribal Health Care Research Project, Port Blair                               |
|             | National Research Institute for Sowa Rigpa, Leh                                        |
|             | Herbal Ayurveda Research Centre, Nagaland                                              |

1. **CENTRAL COUNCIL FOR RESEARCH IN UNANI MEDICINE**

| **S. No.**   | **Name of Institute**                                                                                                                                                                                              |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|              | Central Research Institute of Unani Medicine, Hyderabad                                                                                                                                                            |
|              | Clinical Research Unit , Kurnool                                                                                                                                                                                   |
|              | Regional Research Centre (RRC), Silchar  Extension Centre of RRC, Silchar, Karimganj                                                                                                                               |
|              | Regional Research Institute of Unani Medicine,  Patna                                                                                                                                                              |
|              | Regional Research Institute of Unani Medicine,  New Delhi  Unani Medical Centre*, Dr. Ram ManoharLohia Hospital  Unani Speciality Centre*  Dr.DeenDayalUpadhaya Hospital  *(Extension centres of RRIUM, New Delhi) |
|              | Literary Research Institute of Unani Medicine, New Delhi                                                                                                                                                           |
|              | Drug Standardisation Research Unit, New Delhi                                                                                                                                                                      |
|              | Regional Research Institute of Unani Medicine, Srinagar                                                                                                                                                            |
|              | Clinical Research Unit (Unani), Edathala                                                                                                                                                                           |
|              | Clinical Research Unit (Unani), National Institute of Unani Medicine, Bangaluru                                                                                                                                    |
|              | Clinical Research Unit (Unani), Bhopal                                                                                                                                                                             |
|              | Clinical Research Unit (Unani), Burhanpur                                                                                                                                                                          |
|              | Clinical Pilot Project (Unani), Imphal East                                                                                                                                                                        |
|              | Regional Research Institute of Unani Medicine,  Mumbai                                                                                                                                                             |
|              | Regional Research Institute  of Unani Medicine, Bhadrak, Odisha                                                                                                                                                    |
|              | Regional Research Institute of Unani Medicine,  Chennai                                                                                                                                                            |
|              | Central Research Institute of Unani Medicine, Lucknow                                                                                                                                                              |
|              | Regional Research Institute of Unani Medicine, Aligarh                                                                                                                                                             |
|              | Drug Standardisation Research Institute (PLIM), Ghaziabad                                                                                                                                                          |
|              | Regional Research Centre (RRC), Allahabad                                                                                                                                                                          |
|              | Clinical Research Unit (Unani), Meerut                                                                                                                                                                             |
|              | Chemical Research Unit (Grant- in- aid), Aligarh                                                                                                                                                                   |
|              | Regional Research Institute of Unani Medicine, Kolkata                                                                                                                                                             |

1. **CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY**
| **S No.**   | **Name of Institute**                                                                    |
|-------------|------------------------------------------------------------------------------------------|
|             | Central Research Institute(H),Kottayam, Kerala                                           |
|             | Central Research Institute(H),Noida.(U.P.).                                              |
|             | Regional Research Inst. (H),   Navi Mumbai – 400614                                      |
|             | Regional Research Inst. (H), Gudivada(A.P.)-521301.                                      |
|             | Regional Research Inst. (H) New Shimla (H.P) 171009.                                     |
|             | Regional Research Inst. (H), Puri (Orissa)-752001.                                       |
|             | Regional Research Inst. (H), Jaipur (Rajasthan)-302006.                                  |
|             | Regional Research Institute (H), Guwahati (Assam)                                        |
|             | Homoeopathic Drug Research Institute, Lucknow-226010                                     |
|             | Regional Research Inst. (H),  Imphal (Manipur)795001                                     |
|             | Drug Standardization Unit(H), Hyderabad (A.P.)                                           |
|             | Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy, Kolkata 700035 (W.B.) |
|             | Survey of Medicinal Plants and Collection Unit, Ooty                                     |
|             | Clinical Research Unit(H),   Tirupati  - 517507. (A.P.)                                  |
|             | Clinical Research Unit(H), Chennai 600041.                                               |
|             | Clinical Research Unit (T), Ranchi (Jharkhand) 835240                                    |
|             | Clinical Research Unit (H), Port-Blair (A&N) - 744101.                                   |
|             | Clinical Research Unit(T)  Siliguri – 734006.                                            |
|             | Clinical Research Unit(T) Gangtok (Sikkim)737101.                                        |
|             | Clinical Research Unit(T) Agartala, Tripura (West)                                       |
|             | Clinical Research Unit(T) Puducherry-605013.                                             |
|             | Clinical Verification Unit (H)  Patna – 800008 (Bihar)                                   |

1. **CENTRAL COUNCIL FOR RESEARCH IN SIDDHA**
| **S.No.**   | **Name of Institute**                                                      |
|-------------|----------------------------------------------------------------------------|
|             | Siddha Central Research Institute, Chennai, Tamilnadu                      |
|             | Siddha Regional Research Institute, Puducherry                             |
|             | Siddha Regional Research Institute, Poojappura, Thiruvananthapuram, Kerala |
|             | Siddha Clinical Research Unit, Tirunelveli, Tamilnadu                      |
|             | Siddha Medicinal Plants Garden, Mettur Dam, Tamilnadu                      |

1. **CENTRAL COUNCIL FOR RESEARCH IN YOGA & NATUROPATHY**

| **S.No.**   | **Name of Institute**                                        |
|-------------|--------------------------------------------------------------|
|             | Central Research Institute for Yoga & Naturopathy, New Delhi |