GUIDELINES FOR CENTRAL SECTOR SCHEME OF MINISTRY OF AYUSH

FOR AYURGYAN

1. Background of the Scheme

Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy (AYUSH), offer
a wide range of holistic treatments covering preventive, promotive, curative, rehabilitative and
rejuvenatory needs. These systems of medicine are generally cost effective and valuable and
attracting increasing attention globally. AYUSH systems of medicine are being used for centuries
and have continuous traditions of acceptance and practice. There is a need for spreading the
knowledge; benefits of AYUSH system of medicines to the large section of the peoples across the
globe. The Ministry has two separate schemes for the promotion of AYUSH education and
Research. Now, it is proposed to merge both schemes under one umbrella scheme namely
“AYURGYAN Scheme” to support Education, Research & Innovation in AYUSH by providing
academic activities., training, Capacity Building etc.

Capacity Building and Continuing Medical Education (CME) in AYUSH

Capacity-building is the "process of developing and strengthening the skills, instincts, abilities,
processes and resources that organizations and communities need to survive, adapt, and thrive
in a fast-changing world. The essential ingredient in capacity-building is transformation that is
generated and sustained over time.

The scheme of Continuing Medical Education (CME) was implemented in 11th Plan and has
continued since then, the scheme covered maximum number of AYUSH teachers, doctors,
paramedical and other personnel. However, in the current scenario, there is still a need for
continuing the training for upgrading their professional competence & skills and their capacity
building. Emerging trends of healthcare and scientific outcomes necessitate time to time
enhancement of professional knowledge of teachers, practitioners, researchers and other
professionals. The overall structure of the Scheme is aimed at encouraging AYUSH personnel to
undergo need-based professional training and bridge the knowledge gaps.
Furthermore, it is pertinent to mention here that the Sectoral Group of Secretaries in the
recommendation has suggested for Capacity building of AYUSH workforce.

Research and Innovation in AYUSH Component

AYUSH is the acronym for Ayurveda, Yoga and Naturopathy, Unani, Siddha and
Homoeopathy and includes 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 these therapies, however, still remains to be
done on a wider scale. The then Department of AYUSH has introduced a Scheme for Extra-Mural
Research in addition to the Intra-Mural Research undertaken by the Research Councils for
Ayurveda and Siddha, Unani, Homoeopathy and Yoga and Naturopathy set up by the Ministry of
Health and Family Welfare three decades ago. The off take and output from this scheme has so far
been limited and has yet 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 and development is needed to promote the production
and export of quality products in the form of drugs, neutraceuticals, toiletries and cosmetics.

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 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 and D in priority areas so that the research findings lead to
validation of claims and acceptability of the AYUSH approach and drugs.

2. Objective of the Scheme

2.A. Capacity Building and Continuing Medical Education (CME) in AYUSH
i. To create, enhance and develop constituent’s capacity at country level in the AYUSH
health care sector.
ii. To improve health practices through AYUSH which are sustainable.
iii. To encourage AYUSH professionals to undergo need-based professional orientation
and professional skill development in an organized manner.
iv. To update the professional knowledge of teachers and doctors to adopt good
teaching practices and good clinical practices respectively.
v. To encourage the use of Information technology and web-based education
programmes for widespread dissemination of AYUSH developments and updates.
vi. To train doctors in emerging trends of healthcare and scientific outcomes for keeping
up the standards to health care delivery.
vii. To provide information to doctors on professional journals to keep them
professionally updated. AYUSH-CME Guidelines.
viii. To encourage AYUSH paramedics and health workers to undergo periodical training
for improving healthcare services in hospitals and dispensaries.
ix. To arrange need-based management training programmes to administrators of
AYUSH institutions and hospitals on health aspects for delivering quality services.
x. To update regarding current trends in R & D activities for development of AYUSH
systems and highlight the areas of research and avenues for collaborative activates.
xi. To apprise regarding new Acts/Notifications and other information addressing
regulatory issues in AYUSH systems etc.
xii. To Standardize/validate and develop scientific evidence for AYUSH’ s research and
Education;
xiii. To make scientific exploration of AYUSH system with interdisciplinary approaches; to
achieve need based outcome in priority areas;

2.B. Research and Innovation in AYUSH Component

i. Development of Research and Development (R & D) based AYUSH Drugs for
prioritized diseases;
ii. To generate data on safety, standardization and quality control for AYUSH products
and practices;
iii. To develop evidence based support on the efficacy of AYUSH drugs and therapies;
iv. To encourage research on classical texts and investigate fundamental principles of
AYUSH Systems;
v. To generate data on heavy metals, pesticide residues, microbial load, safety/toxicity
etc. in the raw drugs and finished Ayurveda, Siddha, Unani and Homoeopathy drugs;
vi. To develop AYUSH products having Intellectual Property Rights (IPR) potential for
increasing AYUSH exports
vii. To develop the potential Human Resource in AYUSH systems, especially to inculcate
scientific aptitude and expertise relating to AYUSH systems;
viii. To develop joint research venture among the AYUSH Department and other
Organizations/Institutes.

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3. Components of AYURGYAN Scheme

A. Capacity Building and Continuing Medical Education (CME) in

AYUSH; and

B. Research and Innovation in AYUSH

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3.B. THE SCOPE OF RESEARCH AND INNOVATION IN AYUSH COMPONENT:

The scheme is aimed at developing the opportunity for scientific scrutiny of AYUSH systems
for the benefit of users, researchers, practitioners, industries & common people at large. The
outcomes of the scheme are expected to harness the potential of AYUSH in the interest of public
health delivery. The evidences thus generated will help in propagating rational use, clinical
application & mainstreaming of AYUSH. The scheme would widen the scope for clinical,
fundamental, pharmaceutical, literary and medicinal plant research in Extra Mural mode.

4. PRIORITY AREAS OF RESEARCH:

The scheme will support primarily on the following priority areas: -
I. Fundamental Concepts, Basic Principles & Theories of AYUSH Systems
II. Standardization / Validation of Safety, Efficacy & Quality different AYUSH classical drugs,
Therapies, Intervention & approaches / Treatment modalities
III. AYUSH Pharmaceutical Research (New Drug development)
• Pharmacological studies, safety & toxicity evaluation of ASU&H drugs as per
standard guidelines
• Pharmacokinetics Studies
• Pharmacodynamics Studies
• Development of new dosage forms for classical ASU&H formulation
• Stability & Shelf life studies of ASU&H medicines
• Clinical Trials
IV. Scientific exploration & operational research of metallic compounds, Bhashmas, Kushtas,
Chunduram& other herbomineral preparations
V. The study of integrated approach of treatment involving AYUSH systems
VI. Drug interaction, bioavailability & dose determination studies
VII. AYUSH intervention in public health care in following areas: -
• Epidemics diseases & Genus Epidemicus
• Geriatric Health Care
• Neglected Tropical Diseases (NTD)
• Mental Health & cognitive disorders
• Immunological Disorders
• Anemia & nutritional disorders
• Maternal & Child health
• Study on constitution, temperament and miasms
• Role of AYUSH system as alone or add on treatment in prevention & control of non-
communicable diseases
• Role of AYUSH systems as standalone or adjuvant treatment in National Health
Programme
• Disease prevention / Health promotion
• Vector borne diseases
VIII. Systemic review and meta-Analysis of AYUSH research studies
IX. Literary research & scientific documentation and development of data-base
X. Health Economics related to AYUSH
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XI. Role of ASU & H Intervention in Veterinary Health
XII. Development of software & Bio instrumentation related to AYUSH.

The focus of the AYURGYAN Scheme for Research and Innovation in (AYUSH) will be on the
following:
1. Integrated Health Research
2. Experimental Research/Literary research
3. Epidemiological research
4. Clinical research
a) Disease oriented drug development
b) Development of equipment/ procedure/ clinical tool /Diagnostic
tools/Biomarkers etc
5. Translational Research
6. Policy Research
7. Development of Research Infrastructure- Research Institutes, Labs for Ayurveda as
well as Integrated Health Research
a) Building Academia-Industry co-development partnerships -Establishment of
Business Incubators.
b) Moving technology from lab to commercial scale through AYURTECH
The central government may consider supporting important research proposals in other
areas of National interest depending upon the credential of the institution & investigator.
8. AYUSH Research Programme Young Scholar: - for
➢ Under Graduate; &
➢ Post Graduate students

5. ELIGIBILITY CRITERIA:

5.1Who are eligible

▪ Medical, scientific and Research & Development institution, university/ institutional
department in Govt. & Pvt. Sector with adequate infrastructure & technical expertise
▪ GMP compliant Industries of ASU&H drugs both in public & private sector with R&D
facilities.
▪ Principal Investigator (regular employees in the institution) having minimum five-year
research experience in the concerned field.
▪ Investigator who is the member of Project Appraisal Committee (PAC)/Project
Sanctioning Committee (PSC) would recuse themselves from the decision of those
projects in which they are associated in any capacity.

▪ For AYUSH Research Programe for Young Scholar: -

Under Graduate: - Students who are pursuing their 3rd & final year degree course
Post Graduate: - Students who are in 1st, 2nd year and 3rd year of PG course

5.2Verification of credentials of the Principal Investigator /Institutions

5.2.1 Verification of credentials of the Principal Investigator /Institution, etc. shall be made
by the Ministry of AYUSH /respective Research Councils through predefined guidelines to
assess whether requisite infrastructure to carry out the research project applied for is
available.

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5.2.2 Institutions exempted from verification of credentials
Following are the Institutions exempted from verification of their credentials:
• Statutory/Autonomous Institutions under the Ministry of Health and Family Welfare,
Govt. of India
• CSIR and its Institutions,
• ICMR and its Institutions,
• Accredited Institutions of DST, DRDO
• Central and State Universities/ Institutions
• Deemed Universities declared by the Ministry of HRD, Govt. of India, under the UGC
Act 1956.

5.3 Infrastructure required

The institutions/investigators seeking a project under EMR Scheme should have

adequate infrastructure to pursue the research project. For Example, In case of clinical
research, clinical facilities including OPD and IPD (wherever required) and laboratory facilities
for physiological, bio-chemical, pathological & radiological investigations supported with
necessary equipment relevant to the project should be available. In case of studies for drugs
standardization, safety & toxicity study of the drugs adequate laboratory facilities and animal
house should be in place.

5.4 Investigators:

5.4.1 There will be one Principal Investigator (PI) and not more than two Co-Investigator(s)
[Co-I] but in exceptional cases number of Co-Is may be increased with the approval of PAC/
PSC. The Principal Investigator should have previous experience in the field of the proposed
study. Importance will be given to projects where preliminary work has already been done on
the topic, substantiated by publications. A PI can apply for the project under EMR scheme at
least before 3 ½ years of attaining the age of superannuation in case of project of duration of
3 years. Similar restriction may be imposed for projects of different duration and it may be
ensured that PI must complete the project before superannuation.

The PI or one of the Co-Is should have experience for working in the AYUSH field along
with sufficient research background. In exceptional cases, where PI & Co-Is have no
experience working in AYUSH field, the PSC would decide if the study requires an AYUSH
expert to be engaged as a consultant.

5.4.2 Normally, if the PI and Co-I are having two ongoing research projects from EMR
scheme, further research proposal from them shall not be entertained. Fresh research
proposals may be considered if Committee finds that previous project is on verge of
completion.

5.4.3Change of PI

▪ PIs are encouraged to have a Co-Investigator (Co-I) in the project. However, in one
study there should not be more than two Co-Is but in exceptional cases number of
Co-Is may be increased with the approval of PSC.

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 ▪ If for any reason the PI leaves the project, an eligible Co-investigator could be
considered as the PI subject to recommendation of the PI, the Head of the
Institution, and the approval of the Ministry of AYUSH, as the case may be. Such
request should be sent well in advance.
▪ In case the PI is shifting to any other Institution, the Co-investigator could be made
the new PI, or the project could be transferred to the new Institution with the
mutual agreement of both Institutions and the approval of the Ministry of AYUSH.
▪ If for any reason the Co-I is required to be changed, Prior approval of the institution
and Ministry of AYUSH is mandatory.
▪ The host Institution has an important role to play in the above contract. The
Institution/Principal Investigator will have to inform the Ministry of AYUSH, as the
case may be, of any change, and in consultation with the Ministry of AYUSH take
steps to ensure successful completion of the project before relieving of the
Principal Investigator.

5.4.4 Age of PI

A PI can apply for the project under EMR scheme at least before 3 ½ years of attaining
the age of superannuation for projects of 3 years duration. Similar restriction may be imposed
for projects of different duration and it may be ensured that PI may complete the project
before superannuation. There is no minimum age for PI however he should have experience
of minimum 2 years of work in AYUSH or allied field. The PSC can waive the 2 years experience
condition in case of exceptionally good project.

6. MODE OF APPLICATION FOR GRANT-IN-AID:

6.1 Ministry of AYUSH, shall invite proposals from the individuals, Institutions (both
Government and Private), Universities/Educational Institutions, GMP compliant
Industries of ASU&H drugs both in public & private sector with R&D facilities etc. for
grants-in-aid, under Extra-Mural scheme and also through open advertisement placed
in the National dailies, twice a year (First in the month of January and Second in the
month of July). The advertisement would also be placed on the website of the Ministry
of AYUSH/ websites of the Research Councils and also published in the research
Journal and Newsletter of the Ministry of AYUSH and Research Councils.

6.2 Application shall be submitted both in hard and soft version (in PDF / word files). The
soft copy should be emailed at the designated Email ID of EMR, Ministry of AYUSH on
the following address:-
emr_ayush@yahoo.com,emr-ayush@gov.in

6.3 Scheme details and Application Format shall be available on following sources:
• Website of the Ministry of AYUSH: www.ayush.gov.in
• Website of the Research Councils:

o CCRAS: www.ccras.nic.in
o CCRS: www.siddhacouncil.com, www.siddharesearchcouncil.org
o CCRH: www.ccrhindia.org
o CCRUM: www.ccrum.net
o CCRYN: www.ccryn.org

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 The website of the AYUSH Ministry shall also provide details of the status of the
applications (received, under consideration, approved and rejected).

6.4. The Individuals/Institutions, interested for the grants-in-aid in connection with their
proposed project may apply in the prescribed format (Annexure -1), along with all the
required documents, to the Ministry of AYUSH.

The Ministry of AYUSH and Director Generals/Director of the concerned Research

Councils can also approach reputed Institutions, GMP compliant Industries of ASU&H drugs
both in public & private sector or eminent scientistfor submitting proposals on specified
areas. The Councils will identify top institutions (academic, research, universities etc.) /GMP
compliant Industries of ASU&H drugs both in public & private sector in the country for inviting
good quality proposals. Ministry of AYUSH and Councils may also guide and help them in
formulating the proposals.

6.5 Time line for Receipt of Application

The applications would be received and processed in four quarters:

Quarter Processing by the PAC Processing by PSC

I March. First week March. last week
II June first week June last week
III Sep. first week Sep. last week
IV Dec. First week Dec. last week

6.6 In case of Institutions/GMP compliant Industries of ASU&H drugs both in public & private
sector the PIs have to submit their applications through their Controlling authorities/Head of
the Institutions who will be designated authority responsible for quality work and utilization
of the grant and are accountable in the event of any default. In case of individuals, the PIs
should apply through the Heads of the Institutions with which they want to collaborate.

6.7 Formulation of the Project:

6.7.1 The project proposal should be prepared in the format for application, as given at
Annexure-1. Section A of the Application format requires General Information of the project.
A description of all the projects taken up by the Institutions under EMR Scheme and other
Grant in aid scheme of the Govt. of India is to be given. This would include the Title of the
Study, Objectives, Date of inception of the project, Date of completion, Name and Designation
of the Principal Investigator and Co-Investigators of the study and grant-in-aid received for
the study. Section-B of the Application format requires Bio-Data of PI, Co-I(s) and the
Consultants proposed in the research study. Section-C of the Application is the ‘Brief
Summary of the Project’. Section-D of the application relates to the detailed ‘Protocol’ of the
study.

4 Hard copies and two soft copies (PdF / word files) may be provided by the PIs to the Ministry
of AYUSH.

6.7.2 Preparation of the Protocol and the Research Plan shall be in accordance with the
Guidelines for Methodology and Research and Evaluation of Traditional Medicine (WHO

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2001). Annexure-2 and Annexure-3 indicate broad guidelines on preparation of protocol and
research plan. GCP guidelines for ASU drugs published by Ministry of AYUSH and the‘ Good
Clinical Practices for Clinical Research in India’ provided by Central Drug Standard Control
Organization, Directorate General of Health Services, Ministry of Health and Family Welfare,
GOI may also be referred to.

6.7.3 Ethical clearance from the Institutional Ethics Committee (in case of human trials) or
Institutional Animal Ethics Committee (for animal studies) of the Institutions applying for the
Research Proposal is mandatory. A certificate of clearance from the Institutional Ethics
Committee (IEC) or Institutional Animal ethics Committee (IAEC) is to be enclosed along
with the application form. For Ethical Guidelines and constitution of the Ethics Committee
the Institution may refer to the ICMR Guidelines available at ICMR Website at www.icmr.nic.in
(Hyperlink to ‘About us’ and then ‘Ethical Guidelines for Biomedical research on Human
Subjects’)

6.7.4 Other Documents to be enclosed along with the Application Form

The Institutions (other than those mentioned under 5.2.2) seeking assistance for Research
projects under EMR Grant are required to submit the following documents along with the
Application:
1. A copy of the Memorandum of Association, Rules and Regulations of the Institutions
under which it has been established.
2. A copy of certificate issued to them under the relevant Act wherein it has been
registered (duly attested by a Gazette officer of the Central or State Government)
3. Annual Report along with the Audited Statement of Accounts for the last year.
4. In case, Annual Report of the Institutions is not published, a note on activities during
last year in brief may be enclosed.
5. Ethical clearance certificate from IEC/IAEC (Also to be submitted by Institutions
mentioned under 5.2.2)

7. PROJECT APPROVAL

7.1 Screening and Appraisal of the project

• Once the proposal is received the proposal shall be reviewed by concerned Adviser of
the Ministry and Director General/ Director of the respective Research councils. They
shall submit their opinion/ comments to EMR Cell Ministry of AYUSH within 30 days
of time after receiving of soft copy of proposal. The proposal may also be send for the
comments/ opinion of the eminent subject experts if required by the concerned
Adviser of Ministry of AYUSH.
• EMR cell of the Ministry will facilitate communication with the PI, concerned Adviser
of the Ministry, Research Councils & subject experts.
• The credential of the institutions/PIs will be verified by the respective Councils as
indicated below:-

Name of Research Council for credential verification AYUSH discipline

• Central Council for Research in Ayurvedic Science, (C.C.R.A.S.) Ayurveda

61-65, Institutional Area,Opposite ‘D’ Block, JanakPuri
New Delhi-110058

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 Email: ccras_dir1@nic.inFax: 011-28520748, 011-28525959

• Central Council for Research in Yoga and Naturopathy Yoga &

(C.C.R.Y.N.) Naturopathy
61-65, Institutional Area, Opposite ‘D’ Block, JanakPuri
New Delhi-110058
Email: ccryn@vsnl.net
Fax: 011-28520435, Phone:28520430, 31,32
• Central Council for Research in Unani Medicine, (C.C.R.U.M.) Unani
61-65, Institutional Area, Opposite ‘D’ Block, JanakPuri
New Delhi-110058
Email: ccrum@rediffmail.com, unanimedicine@gmail.com
Fax:011-28522965

• Central Council for Research in Siddha, (C.C.R.S.) Siddha

(SCRI) Building, Arumbakkam,
Chennai-600 106
Email-dgccrs@hotmail.com

• Central Council for Research in Homoeopathy, (C.C.R.H.) Homoeopathy

61-65, Institutional Area, Opposite ‘D’ Block, JanakPuri
New Delhi-110058
Email:ccrh@del3.vsnl.net.in
Fax: 011-28521060

On the basis of the comments received from the concerned Adviser and Director General
of the respective Research councils, the proposal if found suitable shall be placed before the
PSC for further evaluation. PI shall be asked to make a presentation before the Committee.

7.1.1 Project Appraisal Committee (PAC)

The Research proposals of Extra Mural Research (EMR) shall be screened by the PAC
which shall be common for all AYUSH systems constituted by the Ministry of AYUSH and
would comprise of following:
1. JS (AYUSH) or equivalent officer of MoA Chairperson
2. Two experts from the concerned discipline having Member
published research work(to be nominated by
Concerned Adviser of Ministry of AYUSH
3. One Allopathy expert from AIIMS/ICMR like Member
institution(to be nominated by the Secretary
(AYUSH)
4. One science expert from CSIR/DST/DBT(to be Member
nominated by the Secretary (AYUSH)
5. Director Generals /Directors of the Concerned Member
Council or his nominee (not below the rank of DD)
6. Director(IFD) or his nominee ( not below the rank Member
of US)
7. Adv./Jt. Adv./Dy. Adv. of all disciplines of AYUSH Member

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 8. Two co-opted member from scientific background Member
(to be co-opted by Chairperson)
9. Representative of Ministry of AYUSH dealing with Member Secretary
the EMR Scheme

7.1.2 The function of Project Appraisal Committee (PAC)

• Shall call for the Principal Investigator/Co-Investigator to explain their proposals in
person.
• May invite comments from the expert(s) in the concerned field.
• May ask the applicants to modify their proposals (as per observations of the
Committee)
• Return back the proposal to the PI/ Institution highlighting their deficiencies, with
instructions to re-submit the proposals after fulfilling the shortcoming.
• Reject the proposal
• Recommend the proposal to PAC for consideration and approval.
• Give extension of ongoing project for one year without any financial assistance.

7.1.3 The PAC, after thorough evaluation of the technical as well as financial aspects of the
Research Proposals will forward the recommended proposals to the PSC for consideration,
approval and sanction of funds.

7.1.4The work done by the Investigators will also be periodically reviewed by PSC. The PSC
will also approve the subsequent installments.

7.2 Project Sanctioning Committee (PSC)

Project Approval Committee chaired by the Secretary, Ministry of AYUSH, would

consider the proposals recommended by the PSC for acceptance. The PSC would comprise
of:-

1 Secretary (AYUSH) Chairperson

2 Chairperson of PAC Member
3 Financial Adviser or his/her representative (not below the rank of DS) Member
4 Adviser/Joint Adviser/Deputy Adviser of all disciplines of AYUSH Member
5 Representative of DG, ICMR/DGs, CSIR/DST/DBT Member
Not below DDG/Scientist-F level
6 All D.G’s /Director of the Research Councils Member
7 Two co-opted member from scientific background (to be nominated Member
by Secretary (AYUSH))
8 Representative of Ministry of AYUSH dealing with the EMR Scheme Member
Secretary

7.2.1 The Chairperson of the PSC may invite other specialist(s) to attend the meeting of the
PSC to give their expert views on the project proposals. The decision of the PSC in respect of
approval of the research project (s) and sanction/release of funds shall be final.

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7.2.2 An honorarium of Rs. 3,000/- would be paid to co-opted and expert member in PSC and
PSC, it can further be revised by Project Approval Committee with the concurrence of IFD if
required.

7.2.3 An honorarium of Rs. 2,000/- would be paid to reviewer/external expert, it can further
be revised by PSC with the concurrence of IFD if required.

8. OUTCOME OF THE PROJECT:

The final technical and financial reports of each completed study will be examined and
reviewed by the PAC, who will convey their views to the PSC for consideration. PAC will also give
their comments on publication of the results of the studies and the patents claimed by the Ministry
of AYUSH and PI/Grantee institutions jointly. The decision of the PSC in this respect will be final and
binding. Deliverables will be assessed through various outcomes of the project like publication in
reputed journals, product development, patents, technology developed, SOPs, presentations on
International platform etc.

9. FINANCIAL SUPPORT:

9.1 The Ministry of AYUSH will provide financial support for staff, equipment and contingencies
(recurring and non-recurring) for the Research project up to an amount not exceeding Rs.70.00
Lakh.
9.2 One-time financial assistance for an amount of Rs.0.50 lakhs for UG Student and Rs.1.00
lakhs for PG Student.
9.3 The Institution/ GMP compliant Industry of ASU&H drugs both in public & private
sector/individual applying for the grants-in -aid should have adequate staff, equipment and
laboratory/other facilities to conduct the particular research. Financial support will be given only for
the minimum required staff, equipment, books and contingent items.
9.4 Institutional Support not exceeding 10% of the total cost (excluding the cost of equipment)of
the project after successful completion of the project may be provided to the Institution.
9.5 In case of Private Industry the share of grant by the Ministry may not exceed 50 % of the
total cost proposed. The matching share of industry should be made available with each installment
of the fund released by the Ministry.

10. EXPENDITURE:
All recurring and non-recurring items required for work of the project should be purchased
in accordance with the procedures and guidelines of the State Government (for State Government,
Private and Non-Governmental Institutions) or those of the Central Government (in case of Central
Government Institutions). For permanent and semi-permanent assets acquired solely or mainly out
of the grant, the Institutions shall maintain a separate audited record in the form of register such as
cash book, asset register, paid bills, bank statements and bank accounts, etc. The term "assets"
means moveable property where the value exceeds Rs.1000/-. Separate assets registers may be
maintained.

10.1 Non-Recurring Expenditure:

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 Essential scientific equipment including computer and software, if needed, may be
permitted as non-recurring expenditure. However, the quantum of such expenditure will not be
more than 10% of the total cost of salary. The equipment will become the property of the host
institution(s) after successful completion of the project. Books purchased out of the contingencies
may be retained by the Principal Investigator after successful completion of the project.

It shall be ensured that the estimate of expenditure under equipment, books, software, etc
of the required project is sought in the first year itself.
10.2 Recurring Expenditure:

The expenditure of recurring nature such as medicines, chemicals, glassware, cost of

investigations, animals, stationeries, postage, printing, photocopying, etc. may be allowed to
be purchased as a part of the recurring contingencies. However, the quantum of such
expenditure will not be more than 20% of the total cost of salary

10.3 Guidelines for incurring expenditure (both recurring and non-recurring):

The grant can be utilized for purposes like, but not limited to:

1. Acquisition of books, in case these are not available in the library.

2. Chemicals/Consumable items required solely for research project.
3. Charges for specialized investigations for which facilities do not exist in the grantee
institutions.
4. Data entry charges.
5. Printing of questionnaires, case report forms, consent forms, etc. for the research
project.
6. Computer utilities, charges for analysis of data.
7. Typing and printing of research reports.
8. Communication charges

The grant cannot be used for purchase of furniture items, office equipment’s such as
telephone, fax machine, photocopiers, etc.

10.4 Utilization of Travel grant:

The funds earmarked under TA/DA can be utilized, for travel within the country, by the
PI, Co-Investigator or Research staff working on the scheme for the following purposes:
• Attending seminars/symposia/conferences within the country provided the PI
himself/herself or the project staff is presenting a research paper (Related to the
subject of the study), which has been accepted. Copy of the acceptance letter
should be sent to the Ministry of AYUSH.
• Taking up field work/travel connected with the research work.

• Visiting the Ministry of AYUSH for meetings related to the project.

• Attending a training course/seminar/conference/workshop related to the project

The travel grant cannot be used for foreign travel.

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 In utilization of Travel Grant, TA/DA should be as per the rules and guidelines for
entitlement as prescribed by the State Government (for State Government, Private and Non-
Governmental Organisations/Institutions) or those of the Central Government (in case of
Central Government Organisations).

11. PERSONNEL/STAFF:

11.1Scientific Staff

The pre requisite for selection of the scientific staff and their remuneration shall be as
per following table:

S. Staff Qualifications and Experience Amount of

No assistance as per
revised rates of
ICMR*

1. Research Ph.D. in the concerned subject Rs 47,000/- per

Associate OR month + HRA for 1st
(RA): (One or Post-Graduation in Ayurveda/ Siddha/ Unani/ year.
Two) Homoeopathy/ Yoga/Yoga and Rs 49,000/- per
Naturopathy/Sanskrit/Arabic/Persian/Philosophy; month + HRA for 2nd
OR Degree qualification in the respective AYUSH year.
System/ Allopathy; M.Pharma/ M.E./M.Tech./ MVSc. Rs 54,000/- per
with minimum 3 years research experience i.e. month + HRA for 3rd
having worked for any research project funded by year.
the Ministry of AYUSH, ICMR, CSIR, DST or
equivalent organisation.
2. Senior Degree qualification in the related AYUSH system/
Research Allopathy/ Pharmacy/ Pharmacology/ Engineering/ 1st, 2nd and 3rd Year –
Fellow (SRF): Biotechnology/ Agriculture/ Veterinary Science/Bio- Rs.35,000/- per
(One or Two) Statistics/Physiotherapy/ Occupational therapy, etc. month + HRA

Preference will be given to those who possess higher

qualification or who have previous research
experience i.e. having worked for any research
project funded by the Ministry of AYUSH, ICMR, CSIR,
DST or equivalent organisation.
3. Junior • Bachelor Degree in the required discipline 1st, 2nd and 3rd year–
Research Rs 31,000/- per
Fellow (JRF): • Graduate degree in Yoga/Yoga and month + HRA
(One or Two) Naturopathy/Graduate Degree with one year full
time regular PG Diploma/Diploma in Yoga from a
recognized University/Institute with one year
experience (For yoga therapist/yoga instructor)

38
*Revised rates are as per ICMR office order 16/139/2014-ADMN II dt.11-6-2019

Note:1. The qualifications must be recognized by the concerned regulatory Council’s

/Universities/Faculties/Boards.

2. Number of RA/SRF/JRF should be claimed as per actual need of the project and the
decision of the PSC is final in this respect.

3. The amount of assistance for RA/SRF/JRF may be revised by Ministry of AYUSH to

keep at par with the Indian Council of Medical Research (ICMR).
11.2 Supporting Scientific Staff (Consultants):Engagement of minimum number of
supporting staff (Consultants), having expertise in the concerned research study and clearly
identified role in the proposed study, may be proposed with fixed monthly remuneration
which, if approved, may be paid from the head ‘Salary’. In such cases less number of
RA/SRF/JRF may be proposed.

11.3 Non-Scientific Staff: The other supporting staff will be considered on the basis of the
requirement relevant to the study and would be time bound on consolidated emoluments.
Permissible manpower will depend upon the proposal.

11.4Fee to the PIs and Co-Is: as per the details given in the table below may be admissible. In
case of 2 Co-Is or more, this amount shall be shared between them. This fee would be released
only after successful completion of the project and acceptance of the final report of the study
by the PAC /PSC.

Projects having a Projects Projects having a

period of one year having a period of three
period of two years or more
years
Fee of PI Rs. 30,000/- Rs. 60,000/- Rs. 90,000/-

Fee of Co-Is Rs. 15,000/- Rs. 30,000/- Rs. 45,000/-

11.5 General terms and conditions of man-power engagement:

• The appointment of all categories of staff would be made initially for one year and
extended by specific orders for such period as may be necessary, but not exceeding
one year at a time.
• Appointment will be of temporary and contractual nature for a maximum period of
the duration of the study.
• The personnel will have no claim for regular/permanent appointment under the
Research Councils / Ministry of AYUSH or the Grantee Institution on completion of the
period of appointment.
• Dearness Allowance (DA) and City Compensatory Allowance (CCA) are not admissible
to any category of staff employed under EMR projects.
• HRA will be allowed to all categories of JRFs/SRFs and Research Associates as per the
rules of the Institutions where they are working. For this purpose, the fellowship
amounts for JRFs/SRFs and Research Associates will be taken as basic pay.

39
 • Leave, salary and other service benefits: RAs, JRFs, SRFs will continue to be eligible for
the Casual Leave. However, Maternity Leave will be given to female staff as per rule
of Govt.of India.
• Bonus, L.T.C and Retirement benefits are not admissible to RA/SRF/JRF/non-scientific
staff employed for the study.

12. RELEASE OF FUNDS:

The approved grant will be released in the name of the Head of the Institution as yearly
installments. The first installment will be released along with the sanction letter, which would
include the entire grant for purchase of equipment and books, and recurring grant for first year.
The subsequent installment can be claimed on having utilization of 75% the previous installment
subject to special permission of Ministry of Finance. The 2nd/3rd installment(s) would be released
subject to the satisfactory progress of the study, report of monitoring committee and timely
receipt of the following documents in the prescribed proforma:-
• Annual Progress Report (as per Annexure 4)
• No Financial Assistance Certificate (as per Annexure-8)
• Statement of expenditure and Utilization Certificate (Annexure 5,6,7) in original, duly
signed by the PI, Head of the Institution and the Auditor; and
• Mid-term appraisal by monitoring committee or expert(s) after presentation by the
Principal Investigator/Co-I.
• 20% of the approved project cost of the study will be held back till the receipt and
acceptance of final Report & the manuscript.
• This 20% will be released in 2 parts i.e. 10% after acceptance of final report & remaining
10% after publication of the article and receipt of the UC along with audited statement of
accounts.

13. INCEPTION OF PROJECT:

13.1. Date of inception of the project:

The sanction letter shall specify a prospective date from which the project is to be
commenced. If, however, no date is mentioned in the sanction letter, the project shall be deemed
to have become operative from the day the grant is received by the Investigator. This date shall be
communicated by the host Institution to the Ministry within one month from the receipt of the
grant. The date of inception of a project can be changed on the request of the PI, duly forwarded
by the sponsoring institution, provided no expenditure has been incurred by the PI/Institution at
the time of making such request.

14. MAINTENANCE OF ACCOUNT:

The Grantee institution shall maintain a separate account for the grant received and
expenditure incurred. Statement of bank transaction should be submitted at the time of
submission of Utilization Certificate. The account shall be subject to audit by the authorized

40
auditors. An audit certificate from the auditors to the effect that the account has been audited and
the money was actually spent on the objects for which it was sanctioned shall be submitted to the
Ministry of AYUSH. Any unspent balance must be refunded to the Ministry. Further grants will be
released on receipt of audited statement of accounts and utilization certificates along with
detailed expenditure statement (head wise and item wise) in original, duly signed by the PI, Head
of the Institution and the Auditor, within a period of one month after the end of the financial year
for which grant was sanctioned. Voluntary organisations/NGOs will follow other additional
instructions given at Annexure 11.

14.1 Auditors:
The Ministry may normally accept audited reports from statutory auditors. The Ministry may
also accept statement of accounts audited by Chartered Accountants approved by or registered with
CAG and/or Ministry of Health and Family Welfare. The necessary registration number should be
provided for record.

14.2 Expenditure should, on no account, exceed the amount sanctioned (head wise) for the
research project.

14.3 No re-appropriation of funds shall be allowed for over-expenditure in any of the heads or
sub-heads. However, in exceptional cases, re-appropriation of funds, from one head/sub head to
another may be permitted with the prior approval of the PSC.

14.4 All expenditure is to be made as per the norms and guidelines of the Financial Rules as
applicable to the grantee institution.

15. SUBMISSION OF REPORTS:

The following reports on the progress of work done under the research scheme will be
submitted to the Ministry of AYUSH:

15.1. Progress Report

▪ The Progress Report for the first and second year shall be submitted within one month of
completion of reporting year as in the prescribed format at Annexure-4.
▪ The progress of the project shall be evaluated by the Concerned Adviser Ministry of AYUSH
in consultation with peer reviewer/experts if required.
▪ The project may not be continued in the next financial year unless the Ministry receives
the progress report in time.
▪ The PI shall be asked to present the progress at the meeting of the PAC /PSC, if considered
necessary.
▪ The suggestion and views of the PAC/PSC and mid-course correction, if any, conveyed to
the PI, shall be binding on the PI/grantee institution.

Two hard copies and one soft copy (in CD) of the progress report shall be submitted.

15.2. Annual utilization certificate

A statement of accounts indicating the funds received and expenditure incurred thereof by 31 st
March, needs to be submitted along with utilization certificate, duly signed, dated and stamped by
the authorized Auditor, the Principal Investigator and the Head of the Institution (Annexure 5,6,7).

41
 The PI shall also provide a certificate indicating that the grant has not been accepted from any
other institution against expenditure on project concerned.

Unspent balance must be refunded to the Ministry. An audited statement shall be mandatorily
submitted to enable release of the second installment of the annual grant from second year
onwards.

15.3 Only on receipt of the Annual progress Report and Annual Utilization Certificate (at least 75%
if approved by Finance Ministry) previous sanction installment, the release of subsequent
installment (s) of the grant shall be considered subject to special permission of Ministry of Finance.
15.4 The study is liable to be discontinued without any notice to the PI/institution, if a report is
not submitted within the prescribed time.

15.5 Final Project Completion Report

The final report should be sent by the PI/Institution in the prescribed format (Annexure-9)
within three months from the date of completion. Two hard copies and one soft copy (in CD) of
the Final project Completion report shall be submitted. 10% of the amount of the total cost of the
project shall be released after successful completion of the project, duly approved by PSC and
remaining 10% released after publication of the report. The PIs shall ensure that all financial
documents related to earlier grants have been submitted to the Ministry of AYUSH.

16. FINAL SETTLEMENT OF ACCOUNTS

The final settlement of the accounts will be done only after the receipt of the following:

a. Final audited statement of expenditure (Annexure-10).

b. Final utilization certificate (UC) (Annexure -6, 7).
c. List of equipment procured for the project along with their cost and date of purchase and
suggestions for future use.
d. Final Project Completion Report (See Sr. no. 15.5).

17. MONITORING:

Local institutes of concerned councils will monitor the project. If required as special case
Director/ In charge of the institute will co-opted the subject expert for monitoring the project.
PI/Institution shall provide all information and records to the members of the monitoring
committee.

18. AWARD:

PIs and Co-Is who have Completed their projects under EMR during the financial year, may
be considered for AYUSH Award for excellence in Research as per table given below:
Award PIs Co-Is
AYUSH award for excellence in Rs. 50,000/- Rs.25,000/-
Research under EMR scheme
18.1. Extension of the Project: Extension beyond the approved duration normally may not be
entertained except for specific reasons, viz. interesting/important leads emerging which need to

42
be followed-up etc. Duration of project, however, in any case should not go beyond maximum 5
years. One year extension given by Project Screening Committee and if required another year can
be extended by the prior permission of Project Approval Committee. For extension, PI may apply
in the format at Annexure-12.
19. PRE-MATURE TERMINATION OF PROJECT:

19.1. Prior permission of the Ministry of AYUSH shall have to be obtained if the Principal
Investigator desires to discontinue the projects before the expiry of the approved duration. A final
report of the work done is required to be submitted within one month from the date of
termination of the projects. Normally pre-mature termination of the Project may not be allowed
without the refund of entire funds with interest. However, in exceptional circumstances, the PSC
may waive off the return of funds or return of interest or both, decided on case to case basis. In
all such cases, the matter shall be referred to the Ministry of Finance for final decision.
19.2 During the course of the study, the PAC may recommend to the PSC for termination of the
study on ground of Technical/Financial/Ethical irregularities or that the project is not in
accordance with the approval of PSC. The final decision of the PSC shall be binding on the PI and
the grantee Institution. In such case, the Ministry of AYUSH with the prior approval of PSC may
revoke the funds given to the Grantee Institution, partially or fully.

20. INTELLECTUAL PROPERTY RIGHTS AND PATENTS:

20.1 The patent will be jointly applied by the Ministry of AYUSH and the Principal Investigator.
The Ministry of AYUSH/PI will make joint efforts to commercialize the product as applicable.

20.2 The investigator or the staff employed on the research project shall not obtain patents for
any invention/discovery made by them without prior approval of the Ministry of AYUSH.

20.3Ministry of AYUSH will convey such approvals for patent within 3 months from receipt of
application.

21. PUBLICATIONS:
The PI shall submit the final consolidated report (as per Annexure-9) to the Ministry,
after the completion of the project. Outcome of the project shall be mandatorily published in
a reputed peer reviewed (preferably high impact) journal or in the form of book or in the journal
of the Council etc once the projected is approved as completed.
A manuscript of the paper may also be sent by the PI to the Ministry for record. Funding
by the Ministry of AYUSH should be acknowledged in the publication. Any violation of this will
be viewed seriously and may invite penal action. Publications of the study in part or full are not
permissible before acceptance of the final report by the PAC. Expenditure on publication of the
research findings in the journals of repute shall be met from the Scheme.

22. CONFLICT OF INTEREST

In order to maintain the objectivity in the conduct and reporting of research, it is
imperative that the investigators should not have any interests that undermine scientific
integrity while recording and reporting their data. Any research or other links of the
investigators with industry are discouraged as such a link would compromise or likely to
compromise unbiased reporting of research data. In addition, such a financial conflict of
interest could lead to loss of public faith on the credibility of data being reported. All

43
investigators, desirous of the EMR Scheme support should declare financial conflict of interest,
if any, before submitting the project for support. They should also ensure that during the
conduct of the project, they would also observe the same code of conduct. If the Ministry of
AYUSH /Research Council come to know of any unethical conduct on the part of Investigator(s)
including improper/incomplete declaration, the project shall be liable to be terminated,
immediately along with action taken for recovery of funds.

23. IN THE EVENT OF DEFAULT:

1. In the event, the grantee Institution fails to perform its activities, duties, obligations, acts
and deeds as per the scheme and the Annexures appended thereto, the terms of this
agreement, instructions, orders issued from time to time, will amount to default and in such
circumstances, the Ministry of AYUSH can recall the entire funds provided and stop further
release of installments.
2. Designated authority of the Institution shall be held responsible in case the project is not
completed at all or partially completed or not completed in time as agreed. Penal interest -@
18% p.a shall be levied in the case of grantee not complying with the terms and conditions.
However, in exceptional cases, where extension of project timelines becomes necessary, time
period for completion of the projects may be extended without any additional financial
implications. Extension up to maximum of two year period may be given after evaluating the
progress of the project. One year extension given by Project Screening Committee and if
required another year can be extended by the prior permission of Project Approval
Committee.The extension may be given only with the condition that if the project is not
completed within the extended period of two year, the PI and the Institution may be
blacklisted. The Government will transfer the project along with the assets created under the
project to other suitable institutions.

3. All the Officer bearers, Principal Investigators, Co-Investigators, President, Chairperson,

Secretary, or any other person or person(s) functioning to the grant-in-aid Institution shall be
generally and severally responsible and liable to refund the amount with the interest and can
also be prosecuted both under the Civil and Criminal Law for breach or default as stated
above.

4. Jurisdiction: All disputes or differences between the Ministry of AYUSH and the grantee
Institutions shall be decided by referring to arbitration in which the Secretary, Ministry of
AYUSH shall be the arbitrator, whose decision shall be final and binding.

5. PI/Institution not complying with provisions of scheme will be debarred from further
grants.

6. The Courts at Delhi shall have the only and exclusive jurisdiction for all matters connected
to such disputes / differences.

Staff for the Scheme (Research and Innovation).

S. No Name of the post Eligibility Criteria
1. Sr. Consultant – 01 Post-graduate in AYUSH system of medicine 10 year
experience

44
 Remuneration of Rs.75,000/- p.m. OR
(The remuneration as per Ministry of AYUSH guidelines for
engagement of consultant).
2. Consultant – 01 Post-graduate in AYUSH system of medicine 05 year
experience
Remuneration of Rs.55,000/- p.m. OR
(The remuneration as per Ministry of AYUSH guidelines for
engagement of consultant).
3. Data Entry Operator Graduate Degree with 03 year experience
(DEO)/ Office Assistant – preferably in Govt. Sector
02 Remuneration of Rs.20000/- p.m
Note*-Annual Increment at @ 5%.or as per Ministry of AYUSH guidelines, will be applicable
to all the above posts.

ANNEXURE-1

MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY

APPLICATION FOR GRANT-IN-AID OF EXTRA MURAL RESEARCH PROJECTS IN AYUSH
Section-A
1. Title of the Research Project:

2. Details of the Institution submitting the research project

Name: Postal address:
Telephone: Fax: E-mail:
3. In case of Individuals submitting the Research project:
(Name of the collaborating institute may be cited in S. No. 2 above)
Name of the individual: Postal address:
Telephone: Fax: E-mail:
4. Name and Designation of
Principal investigator: Co-Investigator(s): Consultant (s):
5. Duration of Research Project:
i) Period required for pre-trial preparations:
ii) Period which may be needed for collecting the data:
iii) Period that may be required for analyzing the data:

6. Amount of Grant-in-aid asked for:

Total 1st 2nd 3rd Remaining Withheld

Installment Installment Installment Amount amount
(10%) (10%)
Salary
Equipment
Books
Other Non-Recurring
Expenditure
Recurring
Expenditure

45
 TA/DA
Institutional Support
Fee of PI and CoI
Miscellaneous
expenses
Total

7. DECLARATION AND ATTESTATION

Certified that:
I/We have read the provisions, terms and conditions, mentioned in the Extra-mural Scheme
along with its Annexure, Guidelines formulated by the Ministry of AYUSH and I/we shall abide
by the relevant provisions contained under EMR Scheme and General Financial Rules of Govt.
of India.
Name and Signature of the:
a) Principal Investigator
b) Co-Investigator(s)
c) Head of the Department

Signature of the Head of the Institution

Place: Date:
LIST OF DOCUMENTS TO BE ENCLOSED :( As per para 6.7.4 of the scheme and as uploaded on
the website)

46
 Section –B
FORMAT FOR BIO-DATA OF THE INVESTIGATORS (PI, Co-I(s), Consultants)

1. Name (Dr./Mr./Ms.): ____________________________________

First name(s) Surname
2. Designation:

3. Complete Postal Addresses and PIN:

Telephone Number(s), Fax, E-mail

4. Date of birth:

5. Educational Qualification: Degrees obtained (Begin with Bachelor’s Degree)

Degree Institution Field(s) Year

6. Research Experience
Duration (From-To) Institution Particulars of work done

7. Other Experience (Apart from Research)

Duration (From-To) Institution Particulars of work done

8. Research specialization
(Major scientific fields of interest)

9. Financial support received

a) From the Ministry of Health and Family Welfare
Past
Present
Pending

a) From the Ministry of AYUSH

Past
Present
Pending

b) From other Institutions

Past
Present
Pending

10. Research projects in hand under EMR Scheme of Ministry of AYUSH

11. Research Projects in hand under any other Grant-in-aid scheme of Government of India

12. Other research projects, if any:

13. Recent publications (last 5 years, with titles and references), also papers in press

14. Other information, if any:

47
Signature
Date

48
 Section – C
BRIEF SUMMARY OF THE RESEARCH PROPOSAL

[Adequate information must be furnished in a brief but self-contained manner to enable the
Ministry to assess the project.]

1. Title of the Research Project:

2. Objectives

3. Methodology

4. Anticipated Outcome

5. Summary of the proposed research (up to 150 words) indicating overall aims of the
research, importance of the objectives and their application in the context of the priority
areas set out in the application form.

6. Relevance and usefulness of the study with particular reference to concerned AYUSH
system.

7. IPR values

8. Translational Value

9. Utilization of outcomes of project

SECTION-D
Detailed Research Protocol

Give here the design of study as per guidelines for clinical trial protocol including
toxicity investigators, indicating the total number of the cases/samples to be studied, as well
as the mode of selection of subjects specially in experiments involving human subjects,
equipment and other materials to be used, the techniques to be employed for evaluating the
results including statistical methods etc. Also detail the Standard operational procedures
(SOPs) for preparation of trial drugs and method of selection of ingredients should also be
specified. Facilities in terms of equipment, etc., available at the institution for the proposed
investigation are to be specified.

(Also, the Investigator is required to go through the GCP guidelines for ASU drugs published
by Ministry of AYUSH, Good Clinical Practices (GCP) for Clinical Research in India provided by
Central Drug Standard Control Organisation (CDSCO), Directorate General of Health Services,
Ministry of Health and Family Welfare, Govt. of India.)

See Annexure – 2 and 3 for preparation of detailed research protocol.

49
 SECTION-E

Agency Details
Type of Registration
Agency Name
Act/Registration No.
Date of Registration (DD/MM/YYYYYY)
Registering Authority
State of Registration
TIN/TAN No.
Address Line 1
Address Line 2
Address Line 3
City
State
District
Pin Code
Contract Person
Phone
Email

Unique Agency Code

Unique Agency code is like short code of agency, it will accept only alphanumeric value
no special character or space (e.g. if agency name is ABC limited than unique code will
be ABCL or ABCLTD)

Scheme/Bank Details
Scheme
Bank
Address
Branch
Account No.
Agency Name as per bank

50
 REQUISITION FORM FOR THE ELECTRONIC TRANSFER OF FUNDS

(To be submitted in duplicate)

Name of Grantee Institute/ other
organisation

Name of the Bank

Address of the Bank

Account No.
RTGS Code of the Bank (Real Time Gross (IFSC Code)
Settlement Code)

MICR Code No.

Amount to be transferred

()
Under Secretary to the Govt.of India

(FOR THE USE OF PAO(S) ONLY)

Name of the D.D.O

Bill No.

D.V. No.

Cheque No. and Cheque date

Cheque amount

(Sr. Accounts Officer)

Pay &Accounts Office (Sectt.)

51
 ANNEXURE-2

GUIDELINES FOR PREPARATION OF CLINICAL TRIAL PROTOCOL

General information

1. Protocol title, protocol identifying number, and date. Any amendment(s) should also
bear the amendment number(s) and date(s).
2. Name and address of the institute where the study would be conducted
3. Name and Address of the head of the Institute, where the study would be conducted
4. Name and title of the person(s) authorized to sign the protocol and the protocol
amendment(s).
5. Name and title of the investigator(s) who is (are) responsible for conducting the trials,
and the address and telephone numbers(s) of the trial site(s).
6. Name title, address, and telephone number(s) of the qualified physician (or dentist, if
applicable), who is responsible for all trial-site related medical (or dental) decisions (if
other than investigator).
7. Name(s) and address (es) of the clinical laboratory (ies) and other medical and/or
technical department(s) and /or other institutions involved in the trial.
8. Name of the chairman & member Secretary of Institutional Ethics committee.

Background information

1. Previous knowledge of about the subject

2. Name and description of the investigational product(s).
3. A summary of findings from non-clinical studies that potentially have clinical
significance and from clinical trials that are relevant to the trial.
4. References to literature and data that are relevant to the trial, and that provide
background for the trial.
5. Description of the population to be studied
6. Summary of the known and potential risks and benefits, if any, to human subjects.
7. Description of, and justification for, the route of administration, dosage, dosage
regimen, and treatment period(s).
8. A statement that the trial will be conducted in compliance with the protocol, GCP and
the applicable regulatory requirement(s).

Trial objectives and purpose

A detailed description of the objectives and the purpose of the trial.

Trial design:

1. The scientific integrity of the trial and the credibility of the data from the trial depend
substantially on the trial design. A description of the trial design, should include a
specific statement of the primary endpoints and the secondary endpoints, if any, to
be measured during the trial.
2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo-
controlled, parallel design) and a schematic diagram of trial design, procedures and
stages.

52
 3. A description of the measures taken to minimize/avoid bias, including:
(a) randomization
(b) blinding
4. A description of the trial treatment(s) and the dosage and dosage regimen of the
investigational product(s). Also include a description of the dosage form, packaging
and labeling of the investigational product(s).
5. The expected duration of subject participation, and a description of the sequence and
duration of all trial periods, including follow-up, if any.
6. A description of the “stopping rules” or “discontinuation criteria” for individual
subjects, parts of trial and entire trial.
7. Accountability procedures for the investigational product(s), including the placebo(s)
and comparator(s), if any.
8. Maintenance of trial treatment randomization codes and procedures for breaking
codes.
9. The identification of any data to be recorded directly on the case report forms (i.e. no
prior written or electronic record of data), and to be considered to be source data.

Selection and withdrawal of subjects

1. Subject inclusion criteria

2. Subject exclusion criteria
3. Subject withdrawal criteria (i.e. terminating investigational product treatment/trial
treatment) and procedures specifying:
(a) when and how to withdraw subjects from the trial/investigational product treatment;
(b) The type and timing of the data to be collected for withdrawn subjects;
(c) Whether and how subjects are to be replaced;
(d) The follow-up for subjects withdrawn from investigational product treatment/trial
treatment.

Treatment of subjects
1. The treatment(s) to be administered, including the name(s) of all the product(s), the
dose(s), the dosing schedule(s), the route/mode(s) of administration, and the
treatment period(s), including the follow-up period(s) for subjects for each
investigational product treatment/trial treatment group/arm of the trial.
2. Medication(s)/treatment(s) permitted (including rescue medication) and not
permitted before and/or during the trial.
3. Procedures for monitoring subject compliance.

Assessment of efficacy
1. Specification of the efficacy parameters.
2. Methods and timing for assessing, recording, and analyzing of efficacy parameters.

Assessment of safety of trial subjects/research participants

1. Specification of safety parameters.
2. The methods and timing for assessing, recording, and analyzing safety parameters.
3. Procedures for eliciting report of and for recording and reporting adverse event and
intercurrent illnesses.
4. The type and duration of the follow-up of subjects after adverse events.

53
Statistics
1. A description of the statistical methods to be employed, including timing of any planned
interim analysis(ses).
2. The number of subjects planned to be enrolled. In multi-centre trials, the numbers of enrolled
subjects projected for each trial site should be specified. Reason for choice of sample size,
including reflections on (or calculations of) the power of the trial and clinical justification.
3. The level of significance to be used.
4. Criteria for the termination of the trial.
5. Procedure for accounting for missing, unused, and spurious data.
6. Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s)
from the original statistical plan should be described and justified in protocol and/or in the final
report, as appropriate).
7. The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed
subjects, all eligible subjects, evaluable subjects).

Direct access to source data/documents

It should be specified in the protocol that the investigator(s)/institution(s) will permit
trial-related monitoring, audits, institutional review board/independent ethics committee
review, and regulatory inspection(s), by the Research Council/Ministry of AYUSH providing
direct access to source data/documents.
Also the privacy policy to be followed by the Institutions /PI mentioning the persons who would
have an access to the source data and documents related to the research study, is to be
elaborated.

Quality control and quality assurance

The medicine used in the study shall comply the pharmacopoeial and quality standards.

Ethics
Description of ethical considerations relating to the trial.

Data handling and record keeping

The policy to be followed for handling of data, source documents and record is to be mentioned.
If the Institutions does not have any such policy for its research projects, guidelines for data
handling are to be incorporated keeping in view the Confidentiality concerns that will dictate
how data is collected, retained and shared. The data handling and record keeping requirements
can include:
How the Source documents, Case Report Forms, assessment forms, etc would be completed,
checked for inaccuracies?
How long data would be kept?
With whom data can be shared?
Who has rights to the data?
Where and how the data is to be stored
Where and How to Store Research Records?
What computer practices would be followed, i.e. who will enter the data, who would have an
access to the data and how data loss would be prevented?

Financing and insurance

Financing and insurance is to be detailed.

54
 ANNEXURE–3

GUIDELINES FOR TOXICITY INVESTIGATION OF HERBAL MEDICINE

These guidelines are intended to indicate the standard methods of non-clinical

toxicological studies related to assessing the safety of herbal medicines. Not all tests are
necessarily required for each herbal medicine intended for human study.

SHORT TERM TOXICITY TEST

Animal species

Some regulatory agencies require that at least two species be used, one of them to be
selected from rodents and the other from non-rodents.

Sex
In at least one of the species, males and females should be used.

Number of animals

In the case of rodents, each group should consist of at least five animals per sex. In the
case of non-rodents, each group should consist of at least two animals per sex.

Route of administration

Ordinarily, the oral route is sufficient, as this is the normal route of clinical
administration.
However, some regulatory agencies suggest in addition a parenteral route of administration.
In case where it is proposed to administer the herbal preparation to a human subject by the
parenteral route, it may be sufficient to use this route alone for animal testing.

Dose levels

A sufficient number of dose levels should be used in rodents to determine the

approximate lethal dose. In non-rodents, sufficient dose levels should be used for the
observation of overt toxic signs.

Frequency of administration

The test substance should be administered in one or more doses during a 24 hours period.

Observation

Toxic signs and the severity, onset, progression and reversibility of the signs should be
observed and recorded in relation to dose and time. As a general rule, the animals should be
observed for at least seven to fourteen days.
Animals dying during the observation period, as well as rodents surviving to the end
of the observation period should be autopsied.
If necessary, a histopathological examination should be conducted on any organ or
tissue showing macroscopic changes at autopsy.

55
 LONG-TERM TOXICITY TEST
Animal species

Many regulatory agencies require that at least two species be used, one a rodent and
the other a non-rodent.

Sex
Normally, the same number of male and female animals should be used.

Number of animals

In cases of rodents, each group should consist of at least ten males and ten females.
In the case of non-rodents, each group should consist of at least three males and three
females.

When interim examinations are scheduled, the number of animals should be

increased accordingly.

Route of administration

Normally, the expected clinical route of administration should be used.

Administration period

The period of administration of the test substance to animals will depend on the
expected period of clinical use. The period of administration of the toxicity study may vary
from country to country, according to its individual regulations.

The following table reflects commonly used ranges of administration periods:

Expected period of clinical use Administration period for the

toxicity study
Single administration or repeated administrationfor 2 weeks to 1 month
less than one week
Repeated administration, between one week tofour 4 weeks to 3 months
weeks
Repeated administration, between one to sixmonths 3 to 6 months

Long-term repeated administration for more thansix 9 to 12 months

months

As a rule, the test substance should be administered seven days a week.

Administration periods for the toxicity study must be recorded in each result.

Dose levels

Groups receiving at least three different dose levels should be used.

56
 One dose level should not cause toxic changes (no-effect dose) and one dose level that
produces overt toxic effects should be included. Within this range the addition of at least one
more dose may enhance the possibility of observing a dose-response relationship for toxic
manifestations. All studies should include a vehicle control group of test animals.

Observations and examinations

Observations and examinations should be performed on the following items

(from 1 to 6):

1.General signs, body weight and food and water intake

For all experimental animals, the general signs should be observed daily and body
weight and food intake should be measured periodically. If useful, water intake should also
be determined.
The frequency of measurements should normally be as follows:
Body weight: before the start of drug administration, at least once a week for the first three
months of administration and at least once every four weeks thereafter.
Food intake: before the start of drug administration, at least once a week for the first three
months of administration and at least once every four weeks thereafter. If the test substance
is administered mixed in the food, the intake should be measured once a week.

2.Haematological examination

For rodents, blood samples should be taken before autopsy. For non-rodents, blood
samples should be taken before the start of drug administration, at least once during the
administration period (for studies of longer than one month), and before autopsy.

For both haematological and blood chemistry examination, it is desirable to include as

many parameters as possible.

3. Renal and hepatic function tests

Since the liver and kidneys are the usual organs of metabolism and excretion,
potentially toxic agents easily affect them; their functions should be monitored in long-term
toxicity studies. For rodents, a fixed number of animals from each group should be selected
and urinalysis should be performed before the start of drug administration, and at least once
during the administration period.

4. Other function tests

If appropriate, ECG and visual, auditory tests should be performed. For rodents,
ophthalmological examination should be performed on a fixed number of animals from each
group at least once during the administration period; for non-rodents, examination should be
performed on all animals before the start of drug administration and at least once during the
period of administration.

5. Animals found dead during the examination should be autopsied as soon as possible. A
macroscopic examination should be made of organs and tissues. In addition, where possible,

57
organ weight measurements and histopathological examinations should be performed in an
attempt to identify the cause of death and the nature (severity or degree) of the toxic changes
present.

6. In order to maximize the amount of useful information that can be obtained during the
administration period, all moribund animals should be sacrificed rather than allowed to die.
Prior to sacrifice, clinical observations should be recorded and blood samples collected for
haematological and blood chemical analysis. At autopsy a macroscopic examination of organs
and tissues and measurement of organ weights should be recorded. A full histopathological
examination should be performed in an attempt to characterize the nature (severity of
degree) of all toxic changes.

All survivors should be autopsied at the end of the administration period or of the
recovery period after taking blood samples for haematological (including blood chemistry)
examinations; organs and tissues should be examined macroscopically and organ weights
measured. Histopathological examinations of the organs and tissues of animals receiving
lower dosage should also be performed, if changes are found on gross or macroscopic
examination of their organs and tissues of these animals, or if the highest dose group reveal
significant changes. On the other hand, histopathological examination of all rodents will
further improve the chances of detecting toxicity.

Recovery from toxicity

In order to investigate the recovery from toxic changes, animals that are allowed to
live for varying lengths of time after cessation of the period of administration of the test
substance, should be examined.

58
 ANNEXURE- 4

FORMAT FOR PROGRESS REPORT

1. Project title

2. PI (name and address)

3. Co-I (name and address)

4. Other Scientific Staff engaged in the study

5. Non-Scientific Staff engaged in the study

6. Date of start

7. Duration

8. Objectives of the proposal

9. Methodology followed till end of period of reporting

10. Interim modification of objectives/methodology, if any (with

justifications)

11. Summary on progress (during the period of report)

12. Milestones with deliverables achieved during the reporting period as

proposed in the scheme

13. Applied value of the project

14. Research work which remains to be done under the project

15. If additional budget or staff is required for the remaining part of the
research work, please give justifications and details.

Signature of PI:
Date:

Signature of Head of the Institutions:

59
 ANNEXURE- 5

Format for Annual Statement of Accounts to accompany request for release of next
installment

(Year means Financial Year i.e. 1st April to 31st March of next year)

1. Sanction letter No. : ....................... ……………

2. Total Project Cost : Rs…………………………

3. Sanction /Revised Project cost(if applicable) : Rs………….......................

4. Date of Commencement of Project :…………….......................

5. Statement of Expenditure :.………….…......................

S.No. Sanctioned/Head Funds Expenditure Balance Requiremen Remarks

s Allocated Incurred as on t of Funds
(Date) up to 31st
March
1st 2nd 3rd
year Year Year
1 Salary
2 Equipments
3 Books
4 Other Non-
Recurring
Expenditure
5 Recurring
Expenditure
6 TA/DA
7 Institutional
Support
8 Appropriate fee
of PI and CoI
9 Miscellaneous
expenses
10 Total

Signature of Principal Signature of Head of Signature of Authorized

Investigator Institution Auditor
with date & Seal with date& Seal with date& Seal

60
 ANNEXURE-6

Check list for covering note to accompany Utilization Certificate of grant for the project for
the period ending 31st March, 20 __)

1) Title of the project

2) Name of the Institutions

3) Principal Investigator

4) Ministry of AYUSH letter No. and date sanctioning the project.

5) Head of account as given in the original sanction letter

6) Amount received during the financial year (Please give No. and date of Ministry’s
sanction letter for the amount)

7) Total amount that was available for expenditure (excluding commitments) during the
financial year (including amount remaining from earlier installment)

8) Actual expenditure (excluding commitments) incurred during the financial year (upto
31st March).

9) Balance amount available at the end of the financial year.

10) Amount already committed, if any.

61
 ANNEXURE -7
GFR 19-A
FORMAT FOR UTILIZATION CERTIFICATE
(ANNUAL/FINAL)
(To be submitted in original)

S.No. Sanction Amount Certificate

No. & Sanctioned
date
Certified that out of Rs................... of grants-in-aid
sanctioned during the year ………............ in favour of
............................………. under Ministry of AYUSH Letter
No……….............................................. and Rs .
......................................................... on account of
unspent balance of the previous year, a sum of Rs
...................................... has been utilized for the purpose
of …………........................... for which it was sanctioned
and that the balance of Rs . ................................remaining
unutilized at the end of the year has been surrendered to
Ministry of AYUSH letter No. ...........................
Dated…............ /will be adjusted towards the grants-in-
aid payable during the next year
i.e............................................

Total:-

2. Certified that I have satisfied myself that the conditions on which the grant-in-aid was
sanctioned have been duly fulfilled/are being fulfilled and that I have exercised the following
checks to see that the money was actually utilized for the purpose for which it was sanctioned.

Kinds of checks exercised:-

1. Sanction order copy of Government of India.

2. Statement of Expenditure.
3.
4.

Signature of Signature of Head Signature of Authorized

Principal Investigator of the Institution with Auditor
with date& Seal date& Seal of the Institute with date&
Seal

62
 ANNEXURE-8

NO FINANCIAL ASSISTANCE CERTIFICATE

(To be submitted on Institution letter head)

This is certify that no financial assistance has been received from any other Department of
central or state Government/Organisation/Institutions /DBT/DST/CSIR/AIIMS/ICMR etc. for
the project entitled …..(Name of the Project)…. to …. (Name of the PI and Co-I) ….. of (Name
of the Institute).

Signature of Signature of Head Signature of Co-Investigator

Principal Investigator of the Institution with with date & Seal
with date& Seal date& Seal

63
 ANNEXURE-9
FORMAT FOR FINAL REPORT

1. Title of the Project:

2. PI (name and address)

3. Co-I (name and address)

4. Other Scientific Staff engaged in the study

5. Non-Scientific Staff engaged in the study

6. Implementing Institution and other collaborating Institutions

7. Date of commencement

8. Duration

9. Date of completion

10. Objectives as approved

11. Deviation made from original objectives if any, while implementing the project and
reasons thereof.

12. Experimental work giving full details of experimental set up, methods adopted, data
collected supported by necessary tables, charts, diagrams and photographs.

13. Detailed analysis of results indicating contributions made towards increasing the
state of knowledge in the subject.

14. Conclusions summarizing the achievements and indication of scope for future work.

15. Procurement/usage of Equipment

S. Name of Make Cost Date of Utilization Remarks regarding

No. Equipment / FE/Rs Installation rate % maintenance/break
Mode down
l

16. Manuscript for Publication (300 words for possible publication in Council’s Bulletin).

Name and signature with date

64
1. __________________________
(Principal Investigator)
2. __________________________
(Co-Investigator)

65
 ANNEXURE -10

FORMAT FOR FINAL STATEMENT OF EXPENDITURE

(to accompany the Final Report)
(to be submitted in original)

1) Sanction letter No.

2) Total project cost
(Sanctioned/revised project cost, if applicable)
3) Date of commencement of project:
4) Date of completion of project:
5) Grant received in each year (financial):
1st Installment : Date of release of grant……………… grant received
Rs………….
2nd Installment: Date of release of grant……………… grant received
Rs…………..
3rd Installment : Date of release of grant……………… grant received
Rs………….
6) Statement of Expenditure:

S.N Sanctioned/Hea Funds Expenditure Incurred: Financial Year wise Balance Remark
o ds Allocate as on s
(Mention all d (Date)
items under
each head)
1st 2nd 3rd Remainin Withhel
Instt. Instt. Instt. g amount d
(10%) Amount
(10%)
1 Salary
2 Equipment
3 Books
4 Other Non-
Recurring
Expenditure
5 Recurring
Expenditure
6 TA/DA
7 Institutional
Support Charges
8 Appropriate fee
of PI and Co I
9 Miscellaneous
expenses
10 Total

Amount to be refunded/reimbursed (whichever is appropriate): Rs.

66
Signature of Principal Signature of Head of Signature of Authorized
Investigator Institution Auditor
with date& Seal with date& Seal with date& Seal

67
 ANNEXURE-11

GENERAL CONDITIONS FOR THE RELEASE OF GRANT-IN-AID TO NON-GOVERNMENTAL

VOLUNTARY ORGANISATIONS.

1. The Institutions should maintain separate account exclusively with a bank in the name
of the organisation and not of an individual whether by name or by designation. The
accounts should be operated jointly by two office bearers;
2. The entire amount of the grant should be utilized within the period specified in the
sanction letter and only for the purpose for which it is sanctioned;
3. If the grant or any part thereof is proposed to be utilized for a purpose other than that
for which it is sanctioned, prior approval of the Government of India should be
obtained;
4. The accounts of the Institutions should be audited by a Chartered Accountant or a
Government Auditor immediately after the end of financial year. The accounts of the
grant shall be maintained properly and separately from its normal activities and
submitted as and when required. They shall always be open to inspection by any
person authorized on this behalf by this Ministry. They shall also be open to a test
check by the Comptroller and Auditor General of India at his discretion.
5.(i) The grantee Institutions (in not individual) will execute a bond in the prescribed
proforma on a non-judicial stamp paper only with two sureties to the effect that the
organisation will abide by all the conditions of the grants. In the event of any failure
to comply with these conditions or committing any breach of bond the grantee with
sureties individually and jointly will be liable to refund to the Government of India the
entire amount of the grant together with interest thereon;
(ii) The requirement of furnishing two sureties will not be necessary if the grantee
Institutions is a society registered under the Societies’ Registration Act, 1860 or is a
cooperative society; and
(iii) When the bond is also signed by two sureties, both of them should be solvent and
owner of such assets worth not less the amount of the bond as can be attached and
sold in execution by the District magistrate or other equivalent on the body of the
bond;
6. The Institutions should furnish the certificate to the effect that the grantee has not
been sanctioned for the same purpose by any other Department of the Central or
State Government during the period to which the grant relates;
7. When the Central or State Government have reasons to believe that the sanctioned
money is not being utilized for approved purpose, the payment of further grants may
be stopped and the earlier grants recovered;
8. Any portion of the grant, which is not utilized for expenditure upon the objects for
which it was sanctioned, will be refunded in case to the Government of India in this
Ministry;
9. No portion of the grant will be utilized for furtherance of a political movement
prejudicial to the security of the nation;
10. Essential scientific equipment including computer and software if needed may be
permitted as non-recurring expenditure. However, the quantum of such expenditure
will not be more than 25% of the total project cost. The equipment will become
property of the host Institutions after completion of the project. The purchases are to
be made as per rules and the procedures of the hostInstitution. Books purchased out
of the contingencies may be retained by the principal Investigator.

68
11. The grantee will not indulge in corrupt practices;
12. The grantee Institutions should give an undertaking in writing that the grantee agrees
to be governed by the conditions of the grant mentioned in this Annexure and the
sanction letter;
13. The grantee should forward the following documents duly certified as correct by a
Chartered Accountant/Auditor to this Ministry by the Institutions after the grant is
fully utilized: -
(i) A utilization Certificate to the effect that the grant has been utilized for the purpose
for which it was sanctioned; and
(ii) Audited Statement of Accounts reflecting there in the grant and the items of
expenditure incurred there-from.

69
 ANNEXURE-12
REQUEST FOR EXTENSION

(4 Copies to be sent six months prior to the Date of Expiry of the Project)

1. Reference No:

2. Name of the Investigator:

3. Title of the Project:

4. Approved duration of the project from ______________ to _______________.

5. Requested extension from _______________ to ________________.

6. Original objectives (quoted from project proposal)

a.
b.
c.

7. Results achieved so far (in relation to attainment of objectives)

8. Clear statement of objectives that have not been achieved so far but will be achieved
during the extended period:

9. Financial implications:

A. Total Sanctioned Amount:

B. Total expected expenditure till the end of present sanctioned duration:
C. Expected expenditure during extended period:

C.1 Manpower costs (at the existing level)

Existing level means average of last 6-12 months expenditure
C.2 Consumables (at existing level)
C.3 Travel (if absolutely necessary)
C.4 Contingencies

D. Expected amount to be refunded to Ministry of AYUSH

or
Expected amount in addition to the sanctioned amount.

Name and Signature of PI Name and Signature of the Head of the Institution

Seal Seal

70
71
Illustration for financial assistance for different types of projects under EMR Components are
as below: -
Illustration-I
Cost norms for Literary Research/ Policy Research/ Epidemiological Research
Heads 1st year 2nd Year 3rd year Total
Junior Research Rs.31,000/- + Rs.31,000/- + (HRA Rs.31,000/- + -
Fellow (01) (HRA @ 8, 16 & @ 8, 16 & 24%) for (HRA @ 8, 16 &
24%) for 12 12 months 24%) for 12
months months
Rates as per ICMR office Order No. 16/139/2014-ADMN. II dated 11.06.2019 and Department of
Science & Technology OM No. SR/S9/Z-08/2018 dated 30th Jan., 2019
Data entry Rs.20,000/- per Rs.21,000/- per Rs.22,050/- per -
operator (01) month month (including month (including
5% Annual 5% Annual
Increment) Increment)
Field Worker (02) Rs.20,000/- per Rs.21,000/- per Rs.22,050/- per Rs.20,000/-
month month (including month (including per month
5% Annual 5% Annual
Increment) Increment)
Recurring
Expenditure
(20 % of salary)
Equipments Appropriation for
(5 % of salary) Budget for
equipments to be
sought in the 1st
year
Contingency
(5 % of salary)
Fee for PI* - - Rs.90,000/-
(One Time
payment to be
made after
successful
completion of
the Project).
Fee for Co-I* - - Rs.45,000/-
(One Time
payment to be
made after
successful
completion of
the Project).
Institutional - - -
support
(5 % excluding
the cost of
equipment)
(* Fees of PI & Co-I is not application to Investigator in Govt. Service)

72
 Illustration-II
Cost norms for Clinical Research
Heads 1st year 2nd Year 3rd year Total
Salary Rs.47,000/- + Rs.49,000/- + (HRA Rs.54,000/- + -
Research (HRA @ 8, 16 & @ 8, 16 & 24%) for (HRA @ 8, 16 &
Associate (01) 24%) for 12 12 months 24%) for 12
months months
Junior Rs.31,000/- + Rs.31,000/- + (HRA Rs.31,000/- + -
Research (HRA @ 8, 16 & @ 8, 16 & 24%) for (HRA @ 8, 16 &
Fellow (01) 24%) for 12 12 months 24%) for 12
months months
Rates as per ICMR office Order No. 16/139/2014-ADMN. II dated 11.06.2019 and Department
of Science & Technology OM No. SR/S9/Z-08/2018 dated 30th Jan., 2019
Lab Technician Rs.20,000/- per Rs.21,000/- per Rs.22,050/- per -
month month (including month (including
5% Annual 5% Annual
Increment) Increment)
Recurring
Expenditure
(20 % of
salary)
Equipments Appropriation for
(10 % of Budget for
salary) equipments to be
sought in the 1st
year
Contingency
(5 % of salary)
Fee for PI* - - Rs.90,000/-
(One Time
payment to be
made after
successful
completion of
the Project).
Fee for Co-I* - - Rs.45,000/-
(One Time
payment to be
made after
successful
completion of
the Project).
Institutional - - -
support
(5 % excluding
the cost of
equipment)
(* Fees of PI & Co-I is not application to Investigator in Govt. Service)

73
 Illustration-III

Cost norms for Research for new Drug Development/Drug Delivery System Development of
equipment/Clinical Tools/ Diagnostic Tools/ Biomarkers etc.
Heads 1st year 2nd Year 3rd year Total
Salary Rs.47,000/- + Rs.49,000/- + (HRA Rs.54,000/- + -
Research (HRA @ 8, 16 & @ 8, 16 & 24%) for (HRA @ 8, 16 &
Associate (01) 24%) for 12 12 months 24%) for 12
months months
Junior Rs.31,000/- + Rs.31,000/- + (HRA Rs.31,000/- + -
Research (HRA @ 8, 16 & @ 8, 16 & 24%) for (HRA @ 8, 16 &
Fellow (01) 24%) for 12 12 months 24%) for 12
months months
Rates as per ICMR office Order No. 16/139/2014-ADMN. II dated 11.06.2019 and Department
of Science & Technology OM No. SR/S9/Z-08/2018 dated 30th Jan., 2019
Recurring
Expenditure
(20 % of
salary)
Equipments Appropriation for
(10 % of Budget for
salary) equipments to be
sought in the 1st
year

Contingency
(5 % of salary)
Fee for PI* - - Rs.90,000/-
(One Time
payment to be
made after
successful
completion of
the Project).
Fee for Co-I* - - Rs.45,000/-
(One Time
payment to be
made after
successful
completion of
the Project).
Institutional - - -
support
(5 % excluding
the cost of
equipment)
(* Fees of PI & Co-I is not application to Investigator in Govt. Service)

74