Question : Central Regulatory Agency

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

(a) whether the Government has set up/proposed to set up a Central Regulatory Agency for medicines based on AYUSH in the country;

(b) if so, the details thereof and the time by which such an agency is likely to be set up in the country;

(c) whether the Central Council for Research in Ayurvedic Sciences (CCRAS) regulates the research institutions across the country;

(d) if so, the details of the location of these institutes in the country, State/UTwise; and

(e) whether the Government has reviewed the performance of these institutions and if so, the details of the achievements made by these institutions so far?

ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a) & (b): Ministry of AYUSH in the Central Government has a Drug Control Cell to deal with regulatory matters of Ayurvedic, Siddha, Unani and Homoeopathy drugs and to coordinate with State regulatory authorities. Recently, a vertical structure of AYUSH has been created within Central Drugs Standard Control Organization vide order dated 05.02.2018 to oversee the regulation of Ayurvedic, Siddha, Unani and Homeopathy (ASU&H) drugs from central level.
(c) & (d): The Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Ministry of AYUSH, Government of India for undertaking, coordinating, formulating, developing and promoting research on scientific lines in Ayurvedic sciences. CCRAS has a network of 30 peripheral centers located all over India to carry out research activities in the field of Ayurveda and also undertakes collaborative studies with various universities, hospitals and scientific institutes. List of Council’s peripheral centres is annexed.

(e): The Ministry of AYUSH has constituted Review Committees from time to time to assess the functioning and performance of CCRAS and its peripheral centres. Major achievements of CCRAS centres include the following-
i. Carried out 65 clinical research projects in intramural mode on 37 diseases/conditions and 6 collaborative projects during the last ten years. Completed 657 medico-ethno-botanical surveys and 10 intramural projects under medicinal plants research programme.

ii. Drug research studies and intramural projects carried out for standardization of 480 single drugs and 300 compound formulations of Ayurveda.

iii. 10 literary research projects and 51 projects for evaluation of safety, toxicity and pharmacological activities of Ayurvedic drugs have been carried out.

iv. Published 142 books, monographs, select research papers etc. and launched web-based portal for research outcomes of AYUSH systems.

v. Published 1152 research papers; signed 62 MoUs with national and international institutions out of which 20 MoUs are presently operational; filed 18 patent applications; transferred technology to industry for 10 Ayurvedic products; and developed standard Ayurvedic terminology, morbidity codes, integrated research protocols and integrated clinical decision support system.

vi. Undertaken activities in the areas of Clinical Research, Medicinal Plant Research (Medico-ethnobotanical Survey, Pharmacognosy and Cultivation), Drug Standardization, Pharmacological Research, Literary Research & Documentation, Tribal Health Care Programme, Geriatric Health Care and delivery of health care services through out–patient departments (OPDs) and in-patient departments (IPDs).


vii. Performed outreach activities viz. Swasthya Rakshan Programme, Ayurveda Mobile Health Care Programme under Scheduled Castes Sub Plan (SCSP) and integration of Ayurveda in National Programme for Prevention and Control of Cancer, Diabetes, Cardio-vascular Disease and Stroke (NPCDCS), Tribal Health Care Research Programme (THCRP) and initiation of the process for setting up 20 Ayurvedic Health Centres in the states of Assam, Arunachal Pradesh and Sikkim under North East Plan.

viii. Exploratory studies conducted for the feasibility of integration of Ayurveda with the conventional medical system through pilot projects on osteoarthritis and Reproductive & Child Health care.

ix. Formulated of research policy for scientific development of Ayurveda through intramural and collaborative modes.