I.              Introduction

The AYUSH Systems include Ayurveda, Yoga & Naturopathy, Unani, Siddha,  Homoeopathy and include therapies documented and used in these Systems for the prevention and cure of various disorders and diseases.  India has a large infrastructure for teaching and clinical care under these Systems.  The scientific validation of the treatment however still remains to be done on a wide scale.

The Department of AYUSH has introduced a Scheme for extra-mural research in addition to the intra-mural research undertaken by four Research Councils for Ayurveda & Siddha, Unani, Homoeopathy, Yoga & Naturopathy set up by the Ministry of  Health & Family Welfare three decades ago.  The off take and output from this scheme has so far been limited and has not been able to meet the standards for scientific enquiry and outcome effectively.  The Department has taken up a series of programs/interventions wherein evidence based support for the efficacy claims is needed.  Safety, quality control and consistency of products are also very much required.

In the present era of globalization and development of a world market for traditional and herbal medicine, research & development is needed to promote the production and export of quality products in the form of drugs, food supplements, toiletries and cosmetics.  There is an intense competition from other countries in the trade of herbal products.  India’s share in the world market is negligible.  The revised extra-mural research project has, therefore, been designed to encourage R&D in priority areas so that the research findings lead to validation of claims and acceptability of the AYUSH approach and drugs.

II.            Name of scheme(s)

1.             Extra-mural Research (EMR) project Scheme of AYUSH Systems of medicine and Accreditation of Organizations for Research & Development in the fields of AYUSH.

2.             Golden Triangle Partnership (GTP) Scheme for validation of traditional Ayurvedic Drugs and development of new drugs.

1I.1         Extra-mural Research (EMR) project Scheme of AYUSH Systems of medicine and Accreditation of Organizations for Research & Development in the fields of AYUSH.

Objective(s)

·         To develop evidence based support on the efficacy of AYUSH drugs and therapies.

·         To generate data on safety, standardization and quality control of AYUSH products and practices.

·         To facilitate the validation of relevant and promising practices and skills of traditional health practitioners and to further develop their utility for public benefit.

·         To retrieve and revive the rare classical literature and historical aspects of AYUSH.

·         To investigate the fundamental principles of Indian Systems of Medicine.

·         To generate a data base on various aspects of AYUSH practices.

·         To generate data on Heavy metals, Pesticide residues, Microbial load, Safety/Toxicity etc., in the raw drugs & finished ASU & H drugs.

·         To utilize appropriate technologies for development of single and Ply-herbal/herbo-mineral products to make it globally acceptable.

·         To develop the products those have IPR potentials to attract national/multinational pharmaceutical companies.

·         Human Resource Development especially to inculcate Scientific aptitude and expertise relating to AYUSH systems.

III.           Who can submit a proposal

The institutions/investigators seeking a project from the Department of AYUSH should have adequate infrastructure to pursue the research project.  In  case of clinical research, the hospital, laboratory facilities for bio-chemical, pathological, radiological and electro-physiological investigations supported with necessary equipment relevant to the project should be available.  In case of studies for safety and standardization adequate laboratory facilities and animal house should be in place.

The Principal Investigator should have previous experience in the field of the proposed study.  Importance will be given to projects where preliminary work has been done on the topic substantiated by publications.

IV.           When and how to submit a proposal

Any time during the year in the prescribed format and Annexures which can be downloaded from the website.

V.            Areas of research support

(a)       Clinical trials, pharmacology, toxicology, standardization and study of Pharmacology kinetics with respect to the drugs studied under following priority areas/diseases:

First priority:

(i)                   Diabetes mellitus including neuropathy

(ii)                 Peptic ulcer

(iii)                Psoriasis

(iv)               Malnutrition

(v)                 Reproductive Child Health (CH) including infertility & contraceptives

(vi)               Benigh prostate enlargement

(vii)              Preventive cardiology-hypertension, obesity

(viii)            Urolithisis

(ix)                General Health Promotion Rasayana/Medhya Rasayana

(x)                  Mental Health/memory relating disorders

(xi)                Sports Medicine

(xii)               Liver Disorders (Hepatitis B)

(xiii)             Primary health care relating issues

(xiv)             Malaria

(xv)              Filaria

(xvi)             Rheumatoid arthritis

(xvii)           Menstrual disorder

(xviii)          Reproductive tract infection.

Second priority:

i)              Bronchial asthma

ii)             Common ailments affecting children

iii)            Improvement of quality of life in end of life conditions like cancer, HIV, AIDS

iv)           Fever

v)                  Upper respiratory tract infection

vi)           Diarrhoea (including dystentery)

vii)          Indigestion and anorexia

viii)         Skin Diseases

ix)            Cancer, HIV infection

x)             Secondary/tertiary health care relating issues.

(b)           Research on fundamental principles of AYUSH

(i)                   Pancha Mahabhuts – Tridosa

(ii)                 Prakriti, Agni, Srotas, Saptadhalu, Ojas, Ama

(iii)                Rasa, Guna, Virga, Vipaka and Prabhana

(iv)               Similar areas of Siddha, Unani, Homoeopathy, Yoga & Naturopathy.

(c)           Identification and evaluation of promising and widely accepted practices and skills of  traditional healers in rural and tribal areas

(d)           Research on the preventive and promotive aspects AYUSH practices and therapies

(e)           Revival of ancient literature-Survey, collection, transcription/translation, editing and publication of classical literature and text books

(f)            Medico-historical investigations of AYUSH

(g)           Sample survey of contemporary requirements of AYUSH

(h)           Issues relating to the use of Modern Technology to develop the Drugs of AYUSH & Efficacy, Safety, Standards etc.

VI.           Components of grant

Financial support for staff and contingencies – recurring and non-recurring for the project over a period 1-3 years up to a maximum of Rs. 30.00 lakhs.

VII.         Items not allowed out of grant

Buildings, International travel.

VIII.        Mechanism of implementation and monitoring

Ten copies of the detailed research project proposal as per the prescribed proforma may be submitted.  The extramural projects may be of two types to be received through the indirect route and direct route.

a)             The Indirect Route

The indirect route will be initiated on receipt of a letter of intent to conduct research on a specific research area.  The brief outline sent by an applicant would be discussed by a core group of the Research Advisory Group consisting of clinicians, clinical pharmacologists and a statistician and a protocol with focused research methodology will be finalized if the project concept and outline are found to be relevant and worth pursuing.  The investigators and location would be decided and the trials taken up after the protocols are finalized in consultation with the promoters of the project.  In this approach, the onus for getting the approval of the Research Advisory Group to be designated in each case will be of the promoter of the research idea.  Research  Advisory  group   for priority areas other than clinical research could also be constituted if any specific proposals are received.

b)            The Direct Method

The Department of AYUSH through the Central Council for Research in Ayurveda & Siddha (CCRAS), Central Council for Research in Unani Medicine (CCRUM), Central Council for Research in Yoga & Naturopathy (CCRYN) and Central Council for Research in Homeopathy (CCRH) will invite applications with a closing date, from accredited institutions.  Projects may also be awarded to eminent scholars and practitioners, who could route their applications through the heads of accredited organizations.  The grants will be released to concerned organizations who would be responsible for expenditure and utilization of funds.  The proposals would be scrutinized and screened by experts from a panel maintained by the Department.  A  committee chaired by the Secretary of the Department of AYUSH would then consider the proposals recommended for acceptance by the Technical Screening Committee.

c)             The Department may identify suitable investigators as per the requirements of a particular situation and also assign the projects to them.

Project Evaluation Committee:

A Project Evaluation Committee consisting of Adviser (Ayurveda/Unani/Homoeo), Director (CCRAS/CCRUM/CCRYN/CCRH) as the case may be, two subject experts from concerned system of medicine, two representatives of CSIR/ICMR/DST/DBT will evaluate the project allocation, periodically evaluate the work done by the investigators and recommend the grant.  Third party technical experts shall also monitor the quality of research and implementation of the project by spot visits.

Report of work done

Reports on the progress of work done under the research scheme will be submitted to the Department of AYUSH as and when called for.  If a report is not submitted within the prescribed time, the scheme is liable to be discontinued immediately without giving any notice.

Monitoring

The execution of the project will be monitored by a Committee chaired by the Director of the Central Research Council concerned with expert members identified by the Department of AYUSH, every six months.  The Principal Investigator will  make a presentation before the experts or a site visit may be arranged.  The final outcome of the Project will be evaluated by the expert group who will give their recommendation to the Department of AYUSH.

II.2          Golden Triangle Partnership (GTP) Scheme for validation of traditional Ayurvedic Drugs and development of new drugs.

Objective(s)

Recently a component of Golden Triangle Partnership (GTP) has been introduced in the existing EMR Scheme. Under this scheme, three major Partners viz. Department of Ayush, ICMR and CSIR will work together to achieve the following objectives:

·         to bring safe, effective and standardized Ayurvedic products for the identified disease conditions.

·         to develop new Ayurvedic and plant based products effective in the disease conditions of national/global importance.  Products should be better than the available products in the market for such disease conditions.

·         the criteria will be to have best quality, safe and effective products.  Mechanism will be evolved to make products affordable for the domestic market.  Detailed information is available at the website www.indianmedicine.nic.in.

·         to utilize appropriate technologies for development of single and poly-herbal products to make it globally acceptable.

·         the product should have IPR potential to attract national/multi national pharmaceutical companies.

·         all the objectives will be achieved in a mission mode in a period of five years.

For more detailed information about GTP, the website may please be seen.

IX.           Contact Address