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Research Policy

The CCRUM Research Policy 2025 outlines the vision, mission, and objectives of the Central Council for Research in Unani Medicine, emphasizing the need for scientific validation of Unani medicine through comprehensive research. It details the framework for intramural and collaborative research schemes, eligibility criteria, financial support, and guidelines for project implementation. The policy aims to enhance understanding and integration of Unani medicine into mainstream healthcare while promoting quality research and innovation.
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0% found this document useful (0 votes)
10 views132 pages

Research Policy

The CCRUM Research Policy 2025 outlines the vision, mission, and objectives of the Central Council for Research in Unani Medicine, emphasizing the need for scientific validation of Unani medicine through comprehensive research. It details the framework for intramural and collaborative research schemes, eligibility criteria, financial support, and guidelines for project implementation. The policy aims to enhance understanding and integration of Unani medicine into mainstream healthcare while promoting quality research and innovation.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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CCRUM RESEARCH POLICY

2025

CENTRAL COUNCIL FOR RESEARCH IN UNANI MEDICINE


MINISTRY OF AYUSH, GOVERNMENT OF INDIA
CCRUM RESEARCH POLICY 2025
© Central Council for Research in Unani Medicine (CCRUM)
Ministry of Ayush, Government of India, New Delhi - 110058
First Edition – 2013
Second Edition – 2025

Published by:
Central Council for Research in Unani Medicine
Ministry of Ayush, Government of India
61-65, Institutional Area, Janakpuri, New Delhi – 110 058
Telephone: +91-11-28521981, 28525982
Email: [email protected]
Website: https://ccrum.res.in

Printed at:
Santosh Enterprises
1810, Ground Floor, Prasadi Gali,
Kotla Mubarakpur, New Delhi-110003
Contents

Background 1
Vision, Mission, and Objectives of CCRUM 3
Prerequisites for Meeting the Objectives of CCRUM 6
Intra-Mural Research Scheme 7
1. Aims and Objectives 7
2. Priority Areas of Research 8
2.1 Fundamental Research 8
2.2 Literary Research 9
2.3 Drug Research 10
2.4 Clinical Research 11
2.4.1 First Line Priorities 12
2.4.2 Second Line Priorities 15
3. Categories of IMR Schemes for Project 17
Development/Allotment
3.1 Scheme-I 17
3.2 Scheme-II 18
3.3 Scheme-III 19
4. Implementation Guidelines 21
5. Eligibility Criteria 22
5.1 Eligibility 22
5.2 Infrastructure 23
5.3 Investigators of the Project 23
5.4 Age of PI 24
5.5 Role of Principal Investigator (PI) and Co- 24
Investigator (Co-I)
5.6 Change of Principal Investigator (PI) 24
5.7 Number of Projects with the PI 25
6. Methodology and Approach 26
6.1 Statutory, Ethical and Research Guidelines 26
6.2 Quality Assurance & Safety/Toxicity of the Trial 27
Drugs
6.3 Procurement of Trial Drugs 28
6.4 When to Procure the Trial Drug(s) 28
6.5 Laboratory Investigations 29
6.6 Ethical Clearance 30
7. Duration of the Project 30
7.1 Extension of the Project 31
7.2 Premature Termination of the Project 31
8. Financial Support 32
8.1 The Budget 33
8.2 Release of Funds 34
8.3 Operation of Accounts 34
8.4 Re-appropriation of Funds 35
9. Expenditure 35
9.2 Non-Recurring Expenditure 36
9.3 Guidelines for Contingency Grant 36
10. Date of Inception of The Project 36
11. Participating Centres 37
12. Project Staff 37
12.1 Engagement of Project Staff 37
12.2 General Terms and Conditions for Engagement of 38
Project Staff
12.3 Down gradation/Up-gradation of Approved Project 39
Staff
13. Equipment 39
14. Plagiarism 40
15. Selection of Project 40
16. Submission of Reports 40
16.1 Progress Report 44
16.2 Final Project Completion Report 44
17. Monitoring 45
17.1 Local Monitoring 45
17.2 Central Monitoring 45
18. Mode of Application 46
19. Formulation of the Project 46
20. Outcome of the Project 48
21. Intellectual Property Rights and Patents 48
22. Publication 49
Annexures 51
Annexure-1 Application Format for IMR Project
Annexure-2 Budget Justification 57
Annexure-3 Format for Progress Report 58
Annexure-4 Format for Final Report 59
Collaborative Research Scheme at National Level Through 60
Expression of Interest (EoI)
1. Scope of Collaborative Research 60
2. The Priority Areas of Collaborative Research 61
3. Collaborative Research Team 62
4. Eligibility Criteria 63
5. Submission of Project Proposals 63
6. Budget 64
7. Mechanism of Evaluation, Implementation, and 64
Monitoring
8. Financial Support and Duration 66
9. Ethical Considerations 66
10. Project Monitoring, Compliance and Reporting 67
11. Non-Compliance Consequences 67
12. Dissemination of Results 68
13. Certificate Issued by Department of Scientific and 68
Industrial Research (DSIR)
14. Project Shortlisting 68
15. Plagiarism 70
16. Auditors 70
17. Release of Grants 70
18. Re-appropriation of Funds 71
19. Down-gradation/Up-gradation of Approved Posts 71
20. Date of Start 72
21. Utilization of Travel Grant 72
22. Contingency Grant 73
23. Consumable Items Required for Research Work 74
24. Equipment 74
25. Biodata of PI and Co-Investigator 74
26. Annual Progress Report 75
27. Annual Financial Statement 75
28. Final Settlement of the Accounts 76
29. Final Project Completion Report 76
30. Extension of the Project Requests 77
31. Change of PI 77
32. Number of Projects with the PI under Normal 78
Conditions
33. Intellectual Property Rights 78
34. Overhead Expenses 79
35. Publication of Results/Presentation of Papers 79
36. Data Sharing 79
Collaborative Research Scheme at International Level 80
S. Annexures Contents
No
1 Annexure I Format for Submission of Project Proposal 83
2 Annexure II Short Resume Format PI/Co-I 87
3 Annexure Budget Justification 88
III
4 Annexure Declaration & Attestation 90
IV
5 Annexure V Format for Annual Progress Report & 92
Final Year Progress Report
6 Annexure Format for UC & SoE 95
VI
7 Annexure Format for Acceptance with Revised 98
VII Budget/Revised
Proposal, as applicable
8 Annexure MoU Between CCRUM and Collaborating 99
VIII Institute on Non- Judicial Stamp Paper for
Undertaking Collaborative Project
9 Annexure Bond on Non-Judicial Stamp Paper 112
IX (Rs.100/-)
10 Annexure X Undertaking / Certificate 115
11 Annexure Pre-receipt Bill Format 116
XI
12 Annexure Certificate Regarding Availability of 117
XII Relevant Machinery and Equipment with
the Institute
13 Annexure Mandate Form of the Institute for Transfer 118
XIII of Funds
14 Annexure Plagiarism Undertaking for Proposal 119
XIV
BACKGROUND
The Unani System of Medicine is a comprehensive medical system
that offers a wide range of holistic healthcare services to address
the promotive, preventive, curative, rehabilitative and rejuvenatory
needs. The fundamentals, diagnosis and treatment modalities of the
system are based on scientific principles and holistic concepts of
health and healing. Unani medicine is being used for centuries,
with a continuous tradition of acceptance and practice. However,
Unani drugs & therapies need to be validated through an exhaustive
research process based on standard scientific parameters, in order
to spread the knowledge & benefits of Unani system of medicine
to the people nationally and globally.

The Central Council for Research in Unani Medicine (CCRUM) is


an apex autonomous organization functioning under the Ministry
of Ayush, Government of India. Since its establishment in 1978,
the CCRUM has been engaged in conducting scientific research on
the applied as well as fundamental aspects of Unani medicine,
through a network of 24 Research Institutes/Units and four (04)
Co-location centers at reputed tertiary care Hospitals across the
country. Consequently, over the past four decades of its existence,
the Council has made significant strides in preclinical & clinical
research, fundamental research, drug standardization, survey and
cultivation of medicinal plants, and literary research. The Council’s
research programmes, including preclinical safety and
pharmacology, clinical research, fundamental research, cultivation
of Unani medicinal plants, preparation of compound formulations
and their standardization, historical and literary research in Unani
medicine are executed through Intramural and Extramural modes.
The Council undertakes, coordinates, develops, disseminates and
promotes research activities on scientific lines in Unani Medicine.

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The Intramural Research (IMR) Policy was developed in the year
2013 by the CCRUM, in order to encourage its scientists for the
formulation, submission and execution of research projects aimed
at generating quality data for scientific validation of safety and
efficacy of drugs/ therapies and other interventions including
fundamental principles of Unani Medicine. The policy was
approved by the Scientific Advisory Committee (SAC) and
implemented at various Institutes/ Units of the Council. Over the
years, the policy has enabled the scientists engaged in research at
the Council’s centres to carry out and complete their research
projects in an estimated time frame through institutionalised
funding. Research is an ever-changing field and the adoption of the
latest ideas and innovations are integral to the development of any
system. Simultaneously, during the implementation of the IMR
policy at the peripheral centers of the Council, various issues and
suggestions emerged, leading to the development of an updated
version of the policy.
The Collaborative Research Scheme for research in Unani
Medicine aims to promote and support research that enhance
understanding of Unani medicine, its therapeutic potential and its
integration into the mainstream healthcare system. This scheme is
aligned with the broader objectives of promoting health research
and scientific innovation.
The CCRUM has developed operative procedures and guidelines
for the submission and evaluation of Expression of Interest (EoI)
for collaborative research in Unani Medicine. These guidelines
intends to facilitate high-quality research in field of Unani
Medicine and provide a framework for interested researchers and
institutions to submit EoIs for funding consideration.

2
Financial assistance is provided by way of grants to scientists /
professionals who have a regular employment in the Universities,
Unani Medical Colleges, Postgraduate Institutions, recognized
Research and Development Laboratories and Industries, and Non-
Governmental Organizations (NGOs). Proposals exclusively
focusing on Unani Medicine in the form of EoI are considered. The
current policy document will henceforth be referred to as CCRUM
Research policy–2025.
VISION, MISSION, AND OBJECTIVES OF CCRUM
Vision
To strive for excellence and global leadership in the field of Unani
Medicine by comprehensive research for quality assured and cost-
effective products to prevent/ manage/ cure various diseases.
Mission
 To develop CCRUM into a dynamic, vibrant and model
research organization for undertaking, coordinating, aiding
and promoting research in Unani Medicine.
 To bring-up modern scientific knowledge technology to
explore Classical Unani scientific treasure following
prevalent scientific methods through inter disciplinary
approach.
 To attain global leadership in research for treatment and
prevention of emerging diseases of public health
importance.

Objectives
1. To formulate aims and patterns of research on scientific
lines in Unani Medicine.

3
2. To undertake any research or other related programmes in
Unani Medicine including undergraduate, postgraduate and
post-doctoral educational programmes in Unani Medicine.
3. To prosecute and assist in research, propagation of
knowledge and experimental measures generally in
connection with the causation, mode of spread, treatment
and prevention of diseases.
4. To initiate, aid, develop and coordinate scientific research
in different aspects, fundamental and applied aspects of
Unani Medicine and to promote and assist institutions of
research for the study of diseases, their prevention,
causation, treatment, management and other remedial
measures.
5. To provide technical and financial support for research for
the furtherance of objectives of the Central Council.
6. To exchange information with other institutions,
associations and societies interested in the objectives
similar to those of the Central Council and specially in
observation and study of diseases across the globe, East
Asia and in India, in particular.
7. To establish, equip and maintain laboratories, libraries,
institutions and other facilities necessary to fulfill the
objectives of the Central Council
8. To prepare, print, publish and exhibit any papers, posters,
pamphlets, periodicals, standard treatment protocols and
books for furtherance of the objectives of the Central
Council and to contribute to development of such literature.
9. To purchase, construct, maintain and alter any buildings,
including for establishment of research laboratories,
libraries or works necessary or convenient for the purpose
of the Central Council.

4
10. To undertake and accept the management of any
endowment or trust fund for donation, the undertaking or
acceptance whereof may seem desirable.
11. To offer prizes and grant fellowship, scholarships, or
financial assistance including travelling assistance in
furtherance of the objectives of the Central Council.
12. To create administrative, scientific, technical and
ministerial and other posts under the Society and to make
appointments thereto in accordance with the rules and
regulations of the Society.
13. To engage administrative, scientific, technical, ministerial
and other staff under the project on contract basis in
accordance with the procedure laid down by the Executive
Committee.
14. To establish a provident fund and/or pension fund for the
benefit of the Central Council's employees and/or their
family members.
15. To organize and participate in national and international
programmes in Unani Medicine.
16. To undertake R&D consultancy projects and transfer of
patents on drugs and process to industry.
17. To undertake R&D projects sponsored by industries in
Public/Private Sector.
18. To undertake International and Inter-agency collaboration.
19. To utilize results of research conducted and payment of
share of royalties/ consultancy fees to those who have
contributed towards pursuit of such research.
20. To enter into agreement with scientific agencies of other
countries for exchange of scientists, study tours, training in
specialized areas, conducting joint projects etc.

5
21. To provide technical assistance to Govt./Private agencies in
matters consistent with the activities of the Council.
22. To collaborate with, Government of India, in Research and
Scientific Institutions, Academics in achieving its
objectives.
23. To constitute Management Committees consisting of
eminent Scientists/Physicians to monitor the R&D
activities and suggest remedial measures for the
improvement of activities of the Central Council as well as
all Research Institutes of the Council.
24. To do all such other lawful things either alone or in
conjunction with others, as the Central Council, may
consider necessary or as being incidental or conducive to
the attainment of the above objectives.
25. To evolve an integrated system of Indian System of
Medicine (ISM) in coordination with other systems of
medicines.
Prerequisites for Meeting the Objectives of CCRUM
Specialised Skill Development: It is important for the researchers
across all Peripheral Institutes of CCRUM to upgrade the
quantitative and qualitative research method skills periodically.
Capacity building through trainings on knowledge, skills and
attitude of scientists as well as personality development etc so that
the researchers may adopt latest research techniques/tools in their
work.
Upgradation: Efficient and specific basic infrastructure such as
modernization of laboratories, hospitals, up-gradation of existing
facilities, equipment and instruments need to be in place for taking
up the research projects.

6
Collaboration/ Integration: To achieve universally acceptable
outcomes, networking among researchers, National and
International research bodies, academia, industry, policy makers
are essential.
CCRUM has adopted following research schemes for
conducting quality research in Unani Medicine
1. Intra-Mural Research Scheme
2. Collaborative Research Scheme at National Level
3. Collaborative Research Scheme at International Level

INTRA-MURAL RESEARCH SCHEME


1. AIMS AND OBJECTIVES
The aims and objectives of IMR policy are as follows:
(i) Identification, standardization and quality control of single
and compound drugs and development of SOPs for
formulations.
(ii) Survey and cultivation of medicinal plants to ensure
availability of genuine raw Unani drugs.
(iii) Documentation and validation of folk medicinal claims.
(iv) To undertake In-silico/ computational studies on Unani
formulations
(v) To undertake preclinical studies for safety, toxicity and
efficacy evaluation of Unani formulations
(vi) To conduct prevalence studies on priority areas
(vii) To conduct clinical studies especially on new emerging
diseases, where conventional system of medicine has little to
offer.
(viii) To conduct mechanistic preclinical/ clinical studies on Unani
formulations/ therapies

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(ix) To conduct fundamental research studies in the field of
“Omics” to validate the basic concepts of Unani Medicine
(x) Validation of clinical efficacy/safety of Unani classical/
pharmacopoeial formulations including adjuvant therapy and
validation of ‘Ilāj bi’l Tadbīr (Regimenal Therapy).
(xi) Validation of Unani dietary formulations/ recipes (Unani
Aahar/Unani Nutraceuticals)
(xii) To conduct literary and theoretical research in Unani
Medicine including philosophy of medicine, and critical
review, editing and translation of classical texts.
(xiii) To explore new disease indications of existing
pharmacopoeial drugs.
(xiv) To identify areas of promising early-stage research including
analytical review, preclinical research, pilot studies and
observational research.
(xv) To introduce systems for facilitating the replication of
published results and validation of research products.
(xvi) To preserve and validate classical diagnostic methods, such
as Nabḍ (pulse) examination.
(xvii) To conduct systematic review/ meta analysis of various
studies conducted in the field of Unani Medicine.

2. PRIORITY AREAS OF RESEARCH


The primary goal of research at the Council is to develop new drugs
as well as validate traditional Unani therapies and drugs by
adopting appropriate modern research methodology and
technology, without compromising the system’s traditional
essence. To achieve this goal, the Council has identified the
following priority areas of research:
2.1 Fundamental Research

8
Scientific validation of fundamental concepts, basic principles
and theories of Unani Medicine, such as:
i. Studies on theory of Akhlāṭ (Humours), Mizāj
(Temperament) and other Kulliyāt-i Ṭibb (Fundamentals of
Unani Medicine)
ii. Molecular and genetic co-relation studies to understand
Mizāj (temperament) of patients, disease, diet (Unani
Aahar), therapies and drugs
iii. Expression of Mizāj (temperament) and molecular/ genetic/
epigenetic correlation in different individuals, including
healthy volunteers and diseased population, for
understanding biomolecule-temperament relationship,
required for personalized medicine, in order to promote and
preserve health, and to optimize the effectiveness of
treatments by considering the unique genetic factors and
lifestyle modifications that influence an individual’s health
and response to therapy.
iv. Studies on Nabḍ (Pulse)

2.2 Literary Research


Literary and theoretical research in Unani Medicine for
scientific documentation and development of database
i. Survey, collection, collation, editing, elucidation,
digitization, compilation and printing of manuscripts and
rare books of Unani System of Medicine
ii. Critical review, translation, subject-wise compilation and
publication of classical literature of Unani System of
Medicine
iii. Collection, analysis, review and dissemination of research
findings

9
2.3 Drug Research
Ethno-medicinal Research:
i. Survey and documentation of medicinal plants/
cultivation and collection practices, digitization of
herbarium and DNA barcoding for medicinal plants.
ii. Phytochemical and pharmacognostic studies of Unani
drugs
Drug Standardization Research:
i. Establishment of Mizāj (Temperament) of newly
identified drugs and their inclusion into the
Pharmacopoeia after proper verification of therapeutic
claims
ii. Standardization and quality assurance of single and
compound Unani drugs
iii. Development of SOPs for manufacturing of compound
Unani drugs
iv. Development of SOPs on methods of preparation of
Kushtās (Calx) and their standardization
Unani Pharmaceutical Research:
i. Pharmacological studies: preclinical safety, toxicity and
efficacy evaluation, drug interaction, bioavailability and
dose determination studies of Unani drugs as per
standard guidelines
ii. Pharmacokinetics and Pharmacodynamics (PK/PD)
Studies
iii. Reverse Pharmacology:
 Molecular level based mechanisms of action of Unani
drugs
 Demonstrating therapeutic efficacy of Unani drugs by
developing multi-targeted bio-assays system

10
iv. Development of new dosage forms for classical Unani
formulations, as per need and requirement
v. Stability & Shelf-life studies of Unani drugs
vi. Development of experimental (in vivo & in vivo) models
for preclinical research
vii. Developing organ-specific immunomodulators
viii. Co-opting nano techniques for Unani formulations

2.4 Clinical Research


Clinical safety & efficacy studies of Unani drugs, therapies,
interventions & approaches/ treatment modalities for public
healthcare in the following priority areas:
Broad Areas
Clinical validation of Unani Classical/ Pharmacopoeial drugs
New Drug Development:
Clinical research on newer medicinal plants of Indian origin for
various disease conditions
New indications of classical formulations (when indication is
changed with some clinical experience)
Clinical studies with new combinations of a few single drugs
derived from claims of Physicians including traditional healing
practices/folk claims
Modified drug dosage forms/ dosing frequency/ duration of
treatment of the existing classical drugs, e.g. sugar-free
capsules or granules in place of Khamīrās
Clinical validation of various modes of ‘Ilāj bi’l Tadbīr
(Regimenal Therapy)
Development of SOPs and clinical validation of Munḍij-
Mushil (concoctive and purgative) therapy

11
Adjuvant Therapy: Clinical studies of Unani drugs/ therapies
as Add on/ adjuvant therapies to standard conventional
treatments, including cancer chemotherapy, anti-tuberculosis
(ATT) drugs, anti-retroviral drugs, epileptic drugs, etc. to
counter adverse effects of conventional medicines, and to
improve quality of life of patients.
Promotive and Preventive Healthcare
Research & Development in Unani Diagnostics:
Standardization, validation and optimization of Unani
diagnostics, by applying modern scientific tools and
technologies for greater accuracy, without compromising the
unique holistic perspective of Unani System of Medicine
Epidemiological Research: to investigate health patterns,
causes, and outcomes in populations, with the aim of
influencing public health policies, guiding clinical practices,
and informing preventive measures
Geriatrics Care: To conduct clinical research for improving
health & quality of life, reducing disability, and preventing or
delaying age-related disease processes in older individuals
Co-opting artificial intelligence, machine learning for various
diagnostic and treatment, modalities and procedures
Any other areas found to be important from time to time,
including endemics, epidemics, etc.
Prioritized Disease Conditions/Areas
2.4.1 First Line Priorities
i. Skin Diseases
 Baraṣ (Vitiligo)
 Taqashshur al-Jild (Psoriasis)
 Nār Fārsī (Eczema)

12
 Buthūr Labaniyya (Acne vulgaris)
 Qūba (Ringworm) etc.
ii. Musculoskeletal Disorders
 Waja‘ al-Mafāṣil, including rheumatoid arthritis and
osteoarthritis etc.
iii. Clinical Validation of ‘Ilāj bi’l Tadbīr (Regimenal
Therapy)
 Ḥijāma (Cupping Therapy)
 Ta‘līq al-‘Alaq (Leech Therapy)
 Faṣd (Venesection) and
 Other regimens.
iv. Mental Health & Cognitive Disorders (Neurological/
Psychosomatic Disorders):
 Nisyān (Lack of memory/ amnesia)
 Alzheimer's disease)
 (Depression)
 Substance abuse, digital addiction etc.
v. Gastrointestinal Disorders
 Waram al-Kabid (Hepatitis)
 Qarḥa Haḍmiyya (Peptic ulcer)
 Mutalāzima Qūlūn-i-Mutahayyaj/ Ishāl-i-Dimāghī
(Irritable bowel syndrome)
 Iltihāb al-Qūlūn Qurūḥī (Ulcerative colitis)
 Bawāsīr (Haemorrhoids) etc.
vi. Non-Communicable Diseases (NCDs)/ Lifestyle Disorders
 Dhayābīṭus (Diabetes mellitus)
 Ḍaght al-Dam Qawī (Hypertension)
 Ischaemic heart disease
 Dyslipidaemia
 Chronic obstructive pulmonary disease (COPD)

13
 Siman Mufriṭ (Obesity)
 Niqris (Gout) etc.
vii. Respiratory Diseases
 Iltihāb al-Shu‘ab Muzmin (Chronic bronchitis)
 Zeeq un Nafas (Bronchial Asthma)
 Shahīqa (Whooping cough)
 Iltihāb Tajāwīf al-Anf (Sinusitis) etc.
viii. Gynaecological Diseases
 Sayalān al-Raḥim (Leucorrhoea)
 Postmenopausal syndrome etc.
ix. Uro-genital Diseases
 Male Sexual disorders, including Ḍu‘f al-Bāh (Sexual
debility), Sur‘a al-Inzāl (Premature ejaculation), Jarayān
(Semenorrhoea), Qilla al-Manī (Decreased quantity of
semen), etc.
 Qilla al-Nuṭāf (Oligospermia)
 Chronic urinary tract infection
 Ḥaṣā al-Kulya (Nephrolithiasis) and Ḥaṣā al-Mathāna
(Vesical calculus)
 Suqūṭ Kulwī (Renal failure) etc.
x. Maternal & Child Health
 Faqr al-Dam (Anaemia) etc.
 Problems related to pre-natal and post-natal care
xi. Supportive/Adjuvant Therapy
 Supportive/ adjuvant therapy to standard conventional
drugs, including anti-tuberculosis (ATT) drugs/ cancer
chemotherapy/ anti-retroviral (Anti-HIV) drugs,
antiepileptic drugs, etc. for preventing the toxicity of these
allopathic drugs

14
 Adjuvant therapy to improve quality of life (Qol) in
terminal HIV/AIDS and cancer patients
xii. Newly Emerging Disorders
 Dengue fever
 Chikungunya etc.
xiii. Geriatrics Care
 Alzheimer’s disease
 Parkinson’s disease
 Ḍu‘f al-A‘ṣāb (Peripheral neuropathy)
 Sakta/ Ḍarba (Stroke)
 Degenerative joint disease
 Osteoporosis
 Osteomalacia
 Urinary incontinence
 Sexual dysfunction
 Senile purpura
 Anemia in the elderly
 Depression in old age
 Nutritional deficiency in old age
 Preventing diseases and promoting health in old age,
including preventive activities and risk factor management
 Rehabilitation in old age: Rehabilitation of stroke in the
elderly, rehabilitation of specific diseases – parkinsonism,
paraplegia, fracture neck of femur, acute and chronic
arthritis, low back pain
2.4.2 Second Line Priorities
i. Musculoskeletal Disorders
 Osteoporosis
ii. Skin Diseases

15
 Qūba (Ringworm)
 Cosmeto-therapeutics
iii. Neurological Disorders
 Qalaq ‘Uṣābī (Anxiety neurosis)
 Ṣar‘ (Epilepsy)
 Laqwa (Bell’s palsy)
 Fālij (Paralysis)
 Parkinsonism
 Alzheimer’s
iv. Gynaecological and Obstetric Diseases
 Iltihāb ‘Unuq al-Raḥim (Cervicitis)
 Chronic dysfunctional uterine bleeding (DUB)
v. Clinical Validation of Regimenal Therapies in Various
Diseases
 Naṭūl (Douche)
 Takmīd (Fomentation)
 Ḥamām (Baths)
 Dalk (Massage)
 Ābzan (Sitz bath)
 Riyāzat (Exercise)
vi. Dental Problems
 Waram-i-Litha (Gingivitis)
 Dhahāb Mā’ al-Asnān (Teeth hypersensitivity)
vii. Other Diseases
 ‘Iẓam al-Ḥamīd fi’l Gudda-i-Madhī (Benign prostate
hypertrophy)
 Amrāḍ Ghudda-i-Darqiyya (Thyroid disorders)
 ‘Uqr (Infertility)
 Health conditions originating due to radiation,
environmental pollution and climate change

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 Any other disease area of importance

3. CATEGORIES OF IMR SCHEMES FOR PROJECT


DEVELOPMENT/ALLOTMENT
The IMR policy of CCRUM will be operative under the
following schemes:

3.1 SCHEME-I

 IMR projects under Scheme-I will be conceptualized at


CCRUM Headquarters, and these projects will have
centralized funding. The design/protocol of the study
will be formulated at Headquarters level in consultation
with interdisciplinary experts, Principal Investigators
and Co-Investigators. The study design and conduct
should follow the standard research guidelines in the
identified areas of research. These studies may be single-
centric/multi-centric trials and monitoring will be done
through CCRUM headquarters.

 The Study Protocols/ proposals will be approved by DG,


CCRUM after a three tier review process i.e., i) Internal
review by the Internal Multi-disciplinary Research
advisory committee (IMRAC) at the Institute followed
by the Internal Research Committee (IMR-IRC) at
Headquarters ii) External review by concerned subject
experts/ Research Subcommittees iii) Scientific
Advisory Committee (SAC). Once the project is
approved by the SAC, it will be placed before the
Institutional Ethics Committee (IEC), or Animal Ethics
Committee (as applicable). There will be no separate

17
fund allocation for each centre, but the studies will be
funded centrally. Monitoring of the ongoing research
projects shall be conducted on regular basis by internal
monitoring committee as well as committees, e.g. Data
Safety Monitoring Board (DSMB) & Institutional
Review Board (IRB)/Ethical Committee (EC).
Recommendations of the IRB/EC for satisfactory/
unsatisfactory progress of the study shall be placed
before the SAC for the decision. SAC will be having full
authority for discontinuation of any project on the
recommendation of DSMB/IRB/EC. Manuscript of the
study of single-centric/multi-centric trials shall be sent
for publication in peer reviewed journal(s) by the
Principal Investigator(s) after prior approval of DG,
CCRUM.

3.2 SCHEME-II

 IMR projects under Scheme-II will be drafted by the


Scientists of the Peripheral Institute/Unit/Centre and will
be approved by DG, CCRUM after a three tier review
process i.e i) Internal review by the Internal Multi-
disciplinary Research advisory committee (IMRAC) at
the Institute followed by a the Internal Research
Committee (IMR-IRC) at Headquarters, ii) External
review by concerned subject experts/ Research
Subcommittees, iii) Scientific Advisory Committee
(SAC). Once the project is approved by the SAC, it will
be placed before the Institutional Ethics Committee
(IEC), or Animal Ethics Committee (as applicable) for
conducting the study either single-centric/multi-centric.

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 Scientists from the Institute and Unit who are regular
employees of CCRUM and who are not superannuating
during the proposed study period are eligible to become
the Principal Investigator. The study design and conduct
should follow the standard research guidelines in the
identified areas of research. The Principal Investigator
will be one of the scientists from the study team at the
institute/unit who contributed to drafting the protocol,
and shares responsibility for its successful completion,
including publication and proper utilization of funds.
Funds will be provided to the In-charge of the Regional
Institute/ Unit to which the Principal Investigator
belongs. Monitoring will be done through CCRUM
headquarters.

 The Institutes and units under CCRUM to be considered


for projects under this scheme should have adequate
infrastructure to pursue the research project(s) and in
case, such facilities are not available, the same must be
reflected in the project proposal to develop the required
facilities for upgrading the laboratories of the Institute or
otherwise may be outsourced through accredited
laboratories with justification. The tenure of a project
will be maximum for a period of three years. Extension
of the project may be given subject to approval of SAC,
on the recommendation of Internal Research Committee
(IMR-IRC) at Headquarters.
3.3 SCHEME-III

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 Under IMR scheme-III, the Council’s scientists may
collaborate with reputed institutions for research in the
identified areas (specifically based on the facilities
which are not available in the respective Institutes). The
Study Protocols/ proposals will be approved by DG,
CCRUM after a three tier review process i.e., i) Internal
review by the Internal Multi-disciplinary Research
advisory committee (IMRAC) at the Institute followed
by a the Internal Research Committee (IMR-IRC) at
Headquarters, ii) External review by concerned subject
experts/ Research Subcommittees iii) Scientific
Advisory Committee (SAC). Once the project is
approved by the SAC, it will be placed before the
Institutional Ethics Committee (IEC), or Animal Ethics
Committee (as applicable).

 Funds will be provided to the In-charge of the Institute/


Unit or to the In-charge of Collaborating Institute as per
the requirement of the study. These IMR projects may
be conducted in collaboration with other institutes of
scientific repute to generate data on the safety, toxicity,
heavy metals, pesticide residues, microbial load,
standardization, and quality control of Unani drugs and
raw materials, and to provide evidence-based support for
the efficacy of Unani drugs and therapies. In these
studies, the regular employee of the Council will be one
of the investigators and monitoring will be done through
CCRUM Headquarters. The equipment and instruments
procured through the projects will be the property of the
Council. Interim analysis can be conducted on the
recommendation of IMR-IRC, and if the results as per

20
the objectives of the study showed required statistical
significance, then the study can be concluded pre-
maturely with a credit to the Principal Investigator. The
Director General is authorized to invite any expert(s) as
special invitee(s) besides above as per need of the study.

4. IMPLEMENTATION OF THE GUIDELINES:


The IMR Policy will be implemented at all Peripheral
Institutes/Centres of the Council. The guidelines for
implementation of the policy are as follows:
 Depending upon the core strength and the current manpower,
each centre of the Council should identify areas of priority out
of those mentioned in the policy document.
 The centres should mainly focus on research activities in the
identified areas.
 The Scientists working at the Council’s centres should be
exposed to need-based trainings to undertake clinical research
and experimental activities in these areas. The training and
awareness programmes should cover Research Methodology
(Clinical as well as Experimental), Good Clinical Practices
(GCP), Ethics, etc. Administrative and financial trainings for
its staff for the smooth functioning of the projects shall be
organised whenever required.
 Equipment, infrastructure and manpower can be procured for
the activities in the identified areas.
 The CCRUM Headquarters/ its peripheral institutes & units
will make efforts to develop a well-structured mechanism, so
that quality proposals can be submitted for funding.
 For validation of the fundamental concepts of Unani Medicine,
such as Akhlāṭ, (Humours), Mizāj (Temperament), etc.,
researchers should develop proposals for studies on healthy

21
individuals, on diseased population, and in basic sciences for
understanding biomolecule-temperament relationship. Aspects
of genomics, metabolomics and proteomics, etc in
understanding concepts of Unani Medicine and its role in
maintaining health, prevention of diseases should be explored.
These proposals can be collaborative in nature where more than
one centres of the CCRUM or other institutes engaged in
genomics related studies are involved.
 Joint proposals may also be encouraged at different centres of
the Council, which have specified research facilities, e.g.
preclinical, clinical, etc.
 Emphasis on drug standardization covering all its aspects
should be given in the projects.
 The funds shall be released to the peripheral institutes that has
submitted the proposal. However, the Principal Investigator
(PI) will be given sufficient funds for contingency expenses.
 Scientists should publish research findings as early as possible.
 While formulating projects, efforts should be made to work on
a new idea/ concept/ hypothesis, so that innovation becomes
the ‘hallmark’ of the centre.

5. ELIGIBILITY CRITERIA
5.1 Eligibility
Only Research Officers and higher-level scientific staff who
are regular employees of the CCRUM are eligible to apply for
IMR Projects. However, Council’s Scientists may collaborate
with other Institutes as per project requirement and these
projects will be considered by the CCRUM as per procedure.
In such cases, the Council’s Scientists shall be the PI of the
project.

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5.2 Infrastructure
The Principal Investigators submitting a clinical research
project under IMR scheme must ensure that their institute has
adequate infrastructure in that area of research, including OPD,
IPD (wherever required) and laboratory facilities for bio-
chemical, pathological, radiological and other related
investigations supported with necessary equipment and
instruments relevant to the project, as well as prevalence of the
disease condition to be studied.

In case of non-clinical research, including drugs


standardization, and safety & toxicity studies of the drugs,
adequate laboratory facilities and animal house should be in
place to conduct the study. It may be noted that no major
equipment/instruments will be permissible under IMR project.

In case such facilities are not available, the same requirement


must be reflected in the project proposal or may be outsourced
through accredited laboratories. The investigators may also
carry out projects in collaboration with reputed
academic/research institutions.

5.3 Investigators of the Project


There will be one Principal Investigator (PI) and at least one
Co-Investigator (Co-I) from the participating institute, with a
maximum of three Co-Investigators per project per centre, as
per the requirement of the project. Their roles should also be
well-defined in the project.

For multi-centric studies, a group of Principal Investigators


(PIs) from two or three peripheral institutes of the Council may

23
collaborate to submit the proposal after consulting with each
other, and the nodal centre will be decided by the Council
Headquarters. After approval of the project, the PI(s) of
concerned institutes should obtain a duly signed hard and soft
copy of the approved project proposal, along with CRFs and
formats from the respective institutes.

5.4 Age of PI
 There is no minimum age for PI; to serve as Principal
Investigator or Co- Investigator.
 A Principal Investigator (PI) can apply for a research
project under the IMR scheme at least 3½ years before
attaining the age of superannuation, for projects of 3 years
duration. Similar restriction will be applied to projects of
different durations, and PIs must ensure the completion of
the project prior to their superannuation.
5.5 Role of Principal Investigator (PI) and Co-Investigator
(Co-I)
 The roles of PI and Co-I should be well-defined in the
project.
 The Co-Investigator will be responsible for contributing in
any way necessary as required by the PI.
 A Co-Investigator from outside the Council may also be
included in the project based on the need of the project.
5.6 Change of Principal Investigator (PI)
 Principal Investigators are encouraged to have at least one
Co-Investigator (Co-I) in the project from Institute/Center,
so that the Co-I can handle the responsibilities during
leave/absence of the PI. However, in one study there should
not be more than three Co-Is.

24
 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 and the Head of the Institute.
Such a request should be sent well in advance, for approval
of the Council along with consent of the Co-I that he/she
agrees to carry out the project as per the terms and
conditions of the project.
 In case the PI is shifting to any other institute, the Co-
investigator could be made PI or the project could be
transferred to the new institute with the mutual agreement
of both institutions and prior approval of the Council.
 If for any reason the Co-I is required to be changed, prior
approval of the Institute and the CCRUM Headquarters is
mandatory.
 The host Institution has an important role to play in the
above contract. The Institute/ Principal Investigator will
have to inform the Council, of any change, and in
consultation with the Council, take steps to ensure
successful completion of the project before relieving the
original Principal Investigator. Approval of DG, CCRUM
for this change is required.

5.7 Number of Projects with the PI


 Under normal conditions, a PI should only be implementing
a maximum of five IMR research projects (across all IMR
Schemes ) funded by the Council, at a given time point.

 While submitting a research project, the PI should provide


details of all the research projects (completed and ongoing)
under the IMR Scheme, or any other scheme of
Government of India or any other organization.

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 If a PI has five ongoing research projects under the IMR
scheme, further research proposal from him/ her will not be
considered. A new research proposal can only be
entertained if the IMR-Project Evaluation & Monitoring
Committee (IMR-PEMC) finds that the ongoing research
projects are on the verge of completion.

6. METHODOLOGY AND APPROACH

6.1 Statutory, Ethical and Research Guidelines


 The research in any priority area should be undertaken in
accordance with the existing regulatory guidelines.
 The clinical trials should follow the statutory, GCP, ethical
and research guidelines prevalent in India.
 The clinical trials on new drugs should be undertaken as per
the guidelines prescribed by the Ministry of Ayush,
Government of India.
 Pilot studies may be conducted in initial phase to establish
the baseline data and to ascertain the feasibility of the study.
 Protocols will be developed as per standard guidelines.
Parameters related to the philosophies and theories of
Unani Medicine will be given due importance in
formulating the protocols for the studies. Sample size in
each trial will be decided taking all necessary factors into
consideration, and a biostatistician will be consulted for the
development of the protocols.
 The Study protocols should be discussed with the scientists
of different disciplines engaged in clinical research, and it
should be approved by the Institutional Multi-disciplinary

26
Research Advisory Committee (IMRAC) before submitting
the proposal to the Council for approval.
 After approval by the Council, ethical clearance for
conducting the study should be obtained by the IEC or
IAEC (as applicable).
 The clinical trial should be registered with Clinical Trial
Registry of India (CTRI) prospectively, i.e. before the
recruitment of the first patient in the trial.
 In case of single centre studies, the Principal Investigator
(PI) will be responsible to register the trial with the CTRI
for the study.
 The multi-centric trials will be coordinated by Nodal
Institute, identified by the Council Headquarters, and PI of
the Nodal Institute/ coordinating centre will be responsible
to register the trial with CTRI.
 The CCRUM Headquarters will facilitate all the
prerequisites and requisites before and during execution of
the trial.
 As per the requirement of the CTRI format, the sponsor
may be mentioned as CCRUM Headquarters and the PI
may be the person responsible for answering the
scientific/public queries.

6.2 Quality Assurance & Safety/Toxicity of the Trial Drugs


 The standardized drugs (as per Unani Pharmacopoeial
Standards) should be taken for the trial. The physical
characteristics and passport data of the raw materials, along
with the standard operating procedures (SOPs) for
preparation, and certification of analysis for both the raw
materials and the finished product should be properly
documented.

27
 If Unani Pharmacopoeial Standards are not available for a
particular formulation, then in-house standards may be
developed by the Botany and Chemistry Sections at
NRIUMSD, Hyderabad / RRIUM, Chennai, in
collaboration with the concerned Sections at CCRUM
Headquarters.

 If the trial drug is a new drug combination or new dosage


form or new route of administration, then safety/toxicity
studies should also be conducted at the Council’s
laboratories, or any other GLP/Government certified and
NABL-accredited laboratories.

 In case the trial is double blinded and allocation


concealment is done. Then labelling of the drug should be
done accordingly. This will include Header as “Trial/Study
Medication”; Name, place, date of manufacturing and
expiry; Name, designation, official address and contact
number of the PI; Instruction to use and storage;
Emergency contact etc.
6.3 Procurement of Trial Drugs
The trial drugs for the projects will be manufactured and
supplied by the Pharmacies of CCRUM Institutes of Hyderabad
and Chennai.
6.4 When to Procure the Trial Drug(s)
 Upon receiving the sanction order for a particular project,
the Principal Investigator (PI) or Nodal Officer (in case of
a multi-centric study), through the Head of the Institute,

28
will submit the requirement of the trial drug(s), according
to the authentic classical reference, dosage, packaging
specifications, and the total quantity required, to the Head
of the Institute responsible for supplying drug, under
intimation to the Council Headquarters.

 If the project duration is >2 years, the PI must specify the


batch size of the trial drug, along with the supply date,
taking into account the shelf-life of the drug. However, all
batches must adhere to the established quality standards.
6.5 Laboratory Investigations
 The Council’s institutes and centres should have adequate
facilities for laboratory investigations to execute the
research project(s). If such facilities are not available, this
should be clearly stated in the project proposal. Every effort
should be made to develop the required facilities by
upgrading the institute's laboratories, or the work may be
outsourced, if needed. In such cases, codal formalities must
be followed by inviting quotations from at least three
NABL-accredited laboratories, or through a standard
competitive process if three NABL-accredited laboratories
are not available.

 In case of multi-center studies, the Principal Investigator


(PI) of the nodal institute will be responsible for selecting a
central laboratory, taking into consideration that the
branches of such laboratory exist at the vicinity of all
participating centres.

29
 The selected laboratory should undertake that it will not
subcontract any of the investigations to ensure consistency
and maintain quality control across all participating centers
in this study. The methodology, chemicals/kits, equipment,
and/or reference values for the investigations should be
standardized and uniform across all centers.

6.6 Ethical Clearance


 Once the project is approved by the SAC, it is the
responsibility of the Principal Investigator (PI) and the
Head of the concerned Institute to convene a meeting of the
IEC (Institutional Ethics Committee)/IAEC (Institutional
Animal Ethics Committee) (as applicable) to obtain the
ethical clearance. The IEC/IAEC approval should be
communicated to the Council Headquarters before
initiation of the project.
 Subsequently, if the Ethics Committee recommends any
modifications in any component or modality of the project,
the same will be incorporated under intimation to the
Council Headquarters.

7. DURATION OF THE PROJECT


 The duration of a research project submitted under the IMR
policy will be a minimum of three months and a maximum
of 3 years. However, in exceptional cases, especially
requiring long-term studies the maximum duration may be
up to five years subject to recommendation of IMRAC/IRC
/ External Expert Committee / Research Sub-committee.

30
 An additional period of up to 1 year, including up to 6
months’ each for preparatory & post project activities (with
no additional costs) may be incorporated in the project
proposal.

7.1 Extension of the Project


 Requests for project extension beyond the approved
duration would not be entertained routinely. However, if
interesting/important leads are emerging that require
further follow-up, then a valid justification for an extension
should be submitted by the PI three months before the
expected completion of the project along with progress
report, clearly mentioning the period of extension with
justification and reasons why the project could not be
completed within the stipulated sanctioned period.
 Duration of project, however, in any case should not exceed
a maximum of 5 years, barring duration of logistical delay
or unforeseen circumstances.
 The project duration may be extended with the approval of
the DG, CCRUM, and there will be no need to send the
request to the finance section if the extension is within the
approved budget. If additional budget is required for the
extended period, the PI must provide the relevant details
along with a proper justification in the extension request,
and the request must be approved by the Head of the
concerned Institute before it is submitted for final approval
by the finance section and DG, CCRUM .

7.2 Premature Termination of the Project

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 During the course of the study, the Director General,
CCRUM, may recommend for premature termination of the
project on the grounds of technical/ financial/ ethical issues,
or that the project is not in accordance with the established
guidelines. The final decision will be communicated to
concerned Principal Investigator (PI), Co-Investigator (Co-
I), and the Head of the Institute, and it will be binding upon
them. In such cases, any remaining unspent funds will be
refunded to the CCRUM Headquarters.
 If the PI desires to discontinue the project before the expiry
of the approved duration, he/she will have to obtain prior
permission from the CCRUM Headquarters.
 A final report of the work done must be submitted within
one month from the date of termination of the project.
 If the premature termination of the project is due to
deliberate negligence or misconduct by any involved
Officer(s), they may also be liable for disciplinary
proceedings as per rules.

8. FINANCIAL SUPPORT
 The CCRUM will provide financial support for staff,
equipment and contingencies (recurring and non-recurring)
for the IMR projects.
 The Principal Investigators (PIs) applying for the IMR
projects 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 not available at the concerned institutes.
 The project cost will be met from ‘Research Activities’
Head of the sanctioned budget of CCRUM Headquarters.

32
 Any change in budget head, if required, should be made
with the prior approval of the council’s authorities.
 All the expenditure must be made in accordance with the
General Financial Rules (GFR) of the Government of India.
The operation and utilization of accounts of the projects
will be subject to internal audit.

8.1 The Budget


The budget should be proposed based strictly on the actual
requirements. If manpower, instruments, or equipment are
required, a proper justification should be provided, including
details of their existing availability. Generally, staff, equipment,
etc. will be sanctioned on sharing basis for multiple projects and
not exclusively for a single project. The equipment to be asked in
a project should be relevant to that particular project. The furniture,
laptop, data card, mobile phone, and similar items are not
permissible in the project.
The budget should be submitted in the prescribed format
(Annexure - 2). Justification and breakup of all budget heads as
proposed in the proposal should be provided in detail. The budget
would be sanctioned under broad sub-heads as follows:
i. Essential Staff (Pay and Allowance of the Staff)
ii. Contingency (Recurring and Non-recurring)
iii. Consumables
iv. Travel (if approved)
v. Equipment (if approved)
For contingency grants exceeding Rs. 25,000 per annum, a detailed
breakdown must be provided. Once the project is approved by the

33
competent authority, CCRUM will inform the PI about the
sanctioned budget & duration of the project.
8.2 Release of Funds
Funds will be released to the In-charge of the participating
Institutes / Centers / Units and separate account will be maintained
for each project. The amount approved by the SAC for first year
will be released as the 1st instalment at the time of sanction of the
project. Next instalment(s) will be released after review of interim
progress report and UC/statement of expenditure of the 1st
instalment. The statement of expenditure should correspond with
head-wise breakup of budget mentioned in the sanction order. The
PI and head of the institute should also certify that the expenditure
has been incurred for the purpose for which it was sanctioned. The
PI will keep a record for the expenditure incurred by him from the
contingency of the project. After completion of the project, the
concerned PI should submit the audited utilization certificate (UC)
and statement of expenditure along with the final project report.
Every effort should be made to make payment of the liabilities of
a particular financial year within 31st March. The proposal for re-
validation of any unspent balance as on 31st March should be
submitted to the Headquarters of the Council within one month. If
funds are available, then the expenses for laboratory
investigations/contingencies, etc., incurred up to 3rd or 4th week of
March should also be paid within 31st March.
8.3 Operation of Accounts
The funds will be provided to the participating Institute as a part of
Institute’s budget, as per the mechanism followed by the Council
normally. The Head/ In-charge of the Institute will provide the
funds to the Principal Investigator (PI) as per the requirement from

34
time to time. For the purchase of non-recurring items, codal
formalities must be followed.
8.4 Re-appropriation of Funds
Expenditure should on no account exceed the budget sanctioned
for the project. 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 within the sanctioned budget and for unspent
balance may be permitted. If re-appropriation is up to 20% of
concerned subheads under sanctioned budget for the year, then
Head of the Institute will have the liberty to re-appropriate the
funds, under intimation to the Council Headquarters. If re-
appropriation is exceeding 20%, then it should be done with the
prior approval of CCRUM Headquarters. However, the overall
sanctioned budget should remain the same.

9. EXPENDITURE
All recurring and non-recurring items required for the project must
be purchased in accordance with the General Financial Rules
(GFR) of Govt. of India and the procedures in vogue at the host
institute.
For permanent and semi-permanent assets acquired solely or
mainly out of the grant, the institute will maintain a separate
audited record in the form of register in the prescribed format, such
as cash book, asset register, paid bills, bank statements and bank
accounts, etc. 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.

35
Non-Recurring Expenditure
Essential scientific equipment, 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,
instruments and books purchased out of the contingencies will
become the property of the host institute. After purchase, the books
will be recorded in the accession register of the institute’s library
and may be issued to the concerned section or scientist till they are
needed. 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.
Guidelines for Contingency Grant
The contingency grant is meant for both recurring and non-
recurring expenditure, and it can be utilized for the purposes for
which it was sanctioned by the SAC, including, but not limited to:
a. Printing of questionnaire(s), case report forms, consent forms,
etc. for the research project
b. Computer utilities, charges for data analysis (Computer
charges)
Note: The grant cannot be used for purchase of furniture items,
office equipments, such as telephone, fax machine, photocopiers,
etc.
10. DATE OF INCEPTION OF THE PROJECT
 The date of initiation of the project will be the date when
the institute receives the grant. The institute shall
communicate this date to the Council within one month of
receipt of the grant.

36
 After receiving the grant, the Head of the institute will
immediately inform the Principal Investigator (PI) to
initiate the project.
 The date of inception of a project can be changed on the
request of the PI, duly forwarded by the institute, provided
no expenditure has been incurred by the PI/institute at the
time of making such request.

11. PARTICIPATING CENTRES


IMR projects will be carried out at all peripheral institutes of
CCRUM and/or collaborating centres as per the approved
guidelines. Research projects will be submitted by Research
Officers working at the peripheral institutes of the Council.

12. PROJECT STAFF


12.1 Engagement of Project Staff
 The Principal Investigator (PI) may propose the
engagement of JRF/SRF/RA/Consultant (for medical
disciplines)/JRF/SRF/RA (for non-medical
disciplines)/DEO, etc. only based on the project's
requirements with full justification.
 The number of SRF/JRF/RA should be requested as per
actual need of the project and the decision of the SAC in
this regard will be final.
 The remuneration for project staff will be as adopted by
CCRUM as per the guidelines issued by ICMR from time
to time, which may be revised by the CCRUM to keep at
par with the Indian Council of Medical Research (ICMR).
 The remuneration for each project staff will be uniform for
particular category among all the institutes.

37
 Engagement of Consultant: A consultant if required
having expertise in the relevant research / technical work
and a clearly defined role in the proposed study may be
proposed with a fixed monthly remuneration, which, if
approved may be paid under the head “Salary”.
12.2 General Terms and Conditions for Engagement of
Project Staff
i. For the engagement of project staff, a selection
committee will be constituted at the institute level with
the approval of the Council Headquarters, with the
following composition:
 Head of the Institute (Chairman)
 Subject Expert(s)from outside
 DG nominee
 Principal Investigator (Member secretary)
ii. The appointment of project staff in all categories will
be initially for 12 months and extended by specific
orders for such period as may be necessary, but not
exceeding 12 months at a time and not exceeding 36
months for the whole project.
iii. Appointment will be temporary and contractual for a
maximum period of the duration of the project.
iv. The tenure of these temporary project personnel may
be extended at the Institute level, based on the
performance of the incumbent and the
recommendation of the Principal Investigator (PI) not
exceeding the duration of project.
v. In the selection committee's recommendation, there
will be a panel of candidates, comprising one selected
candidate and at least three waitlisted candidates
(subject to availability). This panel will remain valid

38
for one year from the date of approval of the minutes
of selection committee.
vi. The project staff will have no claim for
regular/permanent appointment under the CCRUM on
completion of the period of appointment. Their
engagement will be co-terminus with the project,
which will be clearly mentioned in the appointment
letter of the selected candidate for the project.
vii. It may be noted that any claims for additional
emoluments, perquisites, privileges, or continuation of
project services in any other ongoing project made by
project staff will not be entertained.
viii. The project personnel will receive training from the
Principal Investigator (PI) before initiation of the
study, as required.
12.3 Down gradation/Up-gradation of Approved Project Staff
If the Principal Investigator (PI) would like to downgrade or
upgrade a project staff or convert its post to an equivalent post
with another designation, the PI will send a request to the DG,
CCRUM with adequate justification through the Head of the
concerned institute. The justification will be carefully
examined at the CCRUM Headquarters, and if approved, Head
of the institute will communicate the same to the PI. However,
the PIs will have to manage such re-designations within the
allocated budget and only after receiving the necessary
approvals.

13. EQUIPMENT
 The equipment(s) required for the study, may be purchased from the
non-recurring head of the sanctioned budget for the project, provided
they have been approved by the SAC.

39
 The PIs must include the estimated cost of equipment in the
budget and submit a documentary proof showing the projected
cost, such as an estimate from GeM/E-commerce
platform/Company website.
 All equipments must be purchased in accordance with the
General Financial Rules (GFR) of Govt. of India and
procedures of the institute where the project is to be carried out.
 For all equipments procured from the project funds, a separate
audited record in the form of a register in the prescribed format,
comprising name of equipment, make/model, cost and date of
installation must be maintained by the institute.

14. PLAGIARISM
The project proposals before submission should be subjected to
plagiarism check by standard software. An undertaking in this
regard should be enclosed as per the prescribed format (Annexure
XIV). Plagiarized proposals are liable to get rejected.

15. SELECTION OF PROJECT


15.1 The projects will be evaluated based on their scientific merit,
novelty, and competitiveness. The study protocols/ proposals will
be approved by DG, CCRUM after a three tier review process i.e.,
i) Internal review by the Internal Multi-disciplinary Research
Advisory committee (IMRAC) at the Institute followed by the
Internal Research Committee (IMR-IRC) at Headquarters, ii),
External review by concerned subject experts/ Research
Subcommittees iii), Scientific Advisory Committee (SAC). Once
the project is approved by the SAC, it will be placed before the
Institutional Ethics Committee (IEC), or Animal Ethics Committee
(as applicable).

40
15.2 The composition of the IMR-IRC is as follows:
DDG / Assistant Director (Unani),
1. Chairperson
CCRUM Headquarters
Research Officers (Unani/ allied
2. discipline), CCRUM Headquarters/ Member
Institute
Administrative/Accounts Officer,
3. Member
CCRUM Headquarters
4. Biostatistician Member
Programme Officer, CCRUM Member
5.
Headquarters Secretary

15.3 Term of Reference of IMR-IRC


The IMR - Internal Research Committee (IMR-IRC) after the
scrutiny of the research proposals may:
 Recommend suitable IMR projects to the experts / research
sub-committee /SAC for evaluation.
 Invite the Principal Investigator (PI)/ Co-Investigator (Co-
I) for discussion, if required.
 Invite comments from the expert(s) in the concerned field,
if necessary.
 Inform the PI/Co-I to modify their proposals, if needed.
 Ask the PI/Co-I to provide the papers and documents
related to the project, if necessary.

15.4 The research projects recommended by the IMR-IRC will be


reviewed by a committee of concerned subject experts for their
comments and suggestions. The comments received from the
experts will be appropriately incorporated in to the project.

41
15.5. The projects shall be monitored by a IMR-PEMC which will
periodically review the progress reports of IMR projects submitted
to the Council Headquarters by the respective PIs.
IMR-PEMC may conduct on-site visits, where in the PI will ensure
their access to all the research facilities and documents related to
the project, if necessary.

15.6 The composition of the IMR-PEMC is as follows:


1. Director General, CCRUM Chairman
Unani Expert in relevant field from reputed
2. Member
Unani institute
2 Subject Experts (Co-opted members,
3. Member
Subject-wise, as needed)
4. Biostatistician Member
5. Programme Officer, CCRUM Headquarters Members
Administrative/Accounts Officer, CCRUM
7. Member
Headquarters
DDG / Assistant Director (Unani), Member
8.
CCRUM Headquarters Secretary

15.7 Term of Reference of IMR-PEMC


The Intramural Research-Project Evaluation & Monitoring
Committee (IMR-PEMC) after the evaluation of the research
proposals may:
 Periodically review the progress reports of IMR projects
submitted to the Council Headquarters by the respective
PIs.
 Conduct on-site visits, where in the PI will ensure their
access to all the research facilities and documents related to
the project, if necessary.

42
 Invite the Principal Investigator (PI)/Co-Investigator (Co-
I) for discussion, if required.
 Invite comments from the expert(s) in the concerned field,
if required.
 Invite the PI/ Co-I to make a presentation before the
experts.
 Inform/ask the PI/Co-I to modify their proposals, if needed.
 Reject the research proposals, if not found suitable, with
reasoning.
Also, the IMR-PEMC may:
 Review the progress of the project periodically, as
appraised by the council.
 Ask the PI/Co-I to provide the papers and documents
related to the project, whenever required.
 Monitor the progress of activities through an online
platform to ensure that the project is progressing according
to its objectives and timelines.
 Conduct on-site visits, where in the PI will ensure their
access to all the research facilities and documents related to
the project, as well as to cross check the quality of the
research work, if necessary.
The online monitoring may involve reviewing reports, and
documents submitted electronically, as well as holding virtual
meetings or discussions to resolve any issues or concerns.
15.8 The IMR-PEMC will evaluate the research projects based on
the presentations made by the PI/Co-I. The PEMC has the
discretion to recommend to the SAC, the continuation/extension
/rejection, or modification of the project, or extend the project to

43
any other identified institute as a multi-centric trial, with the officer
who has submitted the project as one of the Investigators.
16. SUBMISSION OF REPORTS
The following reports on the progress of work done under the
IMR scheme will be submitted to the CCRUM:

16.1 Progress Report


 The progress of the project, in accordance with approved
timeline and deliverables, should be submitted to the nodal
officer at the Council Headquarters on a monthly basis.
 The annual progress report for the first and second year
should be submitted within one month of the completion of
the reporting year, in the prescribed format (Annexure-3).
 The project will not be renewed for the next financial year
unless the CCRUM receives the progress report.
 The progress of the project will be evaluated by the IMR-
PEMC in consultation with peer reviewer/experts, if
required.
 The Principal Investigator (PI) may be asked to present the
progress at the meeting of the IMR-PEMC, if considered
necessary.
 The suggestions and views of the IMR-PEMC and mid-
course rectification, if any, will be communicated to the PI,
for the effective conduct of the project, which will be
binding on the PI.
 Two hard copies and one soft copy of the annual progress
report will be submitted to CCRUM.
16.2 Final Project Completion Report

44
 The final report should be sent to the Council Headquarters
by the PI/institute in the prescribed format (Annexure-4),
within three months from the date of completion of the
project.
 Two hard copies and one soft copy (in a pen drive) of the
Final project completion report will be submitted.
17. MONITORING
17.1 Local Monitoring
The Head of the institute/centre will periodically and randomly
review and monitor the progress of ongoing IMR projects at the
institute/centre level through duly constituted Institutional
Multidisciplinary Research Advisory Committee (IMRAC).
These reviews must be reflected in the periodic
(monthly/quarterly/annual) progress reports of the institute, which
are submitted to the Council Headquarters. If necessary, as a
special case, the Head of the institute may co-opt a subject expert
for monitoring the project. The PI shall provide all necessary
information and records related to the project to the members of the
IMRAC. The expenditure incurred for this purpose may be borne
from the allotted budget of the scheme.
17.2 Central Monitoring
There will be an IMR-Project Evaluation & Monitoring Committee
(IMR-PEMC) at CCRUM Headquarters to monitor the technical
and financial execution of the IMR projects. The PI shall provide
all necessary information, records, papers and documents
pertaining to the research project to the members of the IMR-
PEMC, as and when required.

45
18. MODE OF APPLICATION
18.1 The Principal Investigators have to submit their IMR
proposals in the prescribed format, along with all the required
documents through E-mail to [email protected],
[email protected] or any other email notified on the website.
18.2 The PIs have to submit their applications to the Director
General, CCRUM through their Controlling Authorities/Heads of
the institutes, who will be designated authority responsible for
ensuring the quality work and proper utilization of the grant, and
will be held accountable in case of any default.
18.3 Projects that have already been completed under the IMR
Scheme may also be taken up for further research to reach their
logical conclusion.
18.4 Any IMR proposal (hard or soft copies) received without
forwarding letter from the Head of respective institute will not be
considered.
18.5 The PIs/Head of the concerned research institute can also
approach reputed institutions (academic, research, universities,
etc.), for submitting good quality proposals on prioritized areas, for
IMR projects under Scheme-III.
18.6 Timelines for Receipt of Application
The applications for IMR projects from all the peripheral
institutes/centre/units of the Council would be received half-yearly
in April and October every year.
18.7 The details of the scheme, along with all necessary formats
and the checklist of mandatory requirements for IMR projects are
available on the website of CCRUM (https://ccrum.res.in).
19. FORMULATION OF THE PROJECT
19.1 The project proposal should be prepared in the prescribed
format mentioned in Annexure–1 (Section A, B, C & D).

46
Section A of the application format requires General
Information of the project, including study title, details of the
concerned Institute, Principal Investigator and Co-
Investigator(s), duration & timelines of the project and
budgetary requirement. Also, a description of all the research
projects taken up by the Principal Investigator (PI) in the last
three years (both completed and ongoing) under IMR Scheme
and any other Grant in aid Scheme of the Govt. of India is to be
given as per the format.
Section B of the Application format requires Bio-Data of PI,
Co-I(s) and Consultant proposed in the 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.

(Note: It is mandatory to submit the application in 2 hard copies


and one soft copy on a pen drive)
19.2 Preparation of the protocol and the research plan shall be in
accordance with the “Guidelines for Methodologies on Research
and Evaluation of Traditional Medicine” published by WHO in
2000, and “GCP Guidelines for Clinical Trials in ASU systems
(GCP-ASU)” published by erstwhile Department of AYUSH,
Ministry of Health & Family Welfare, Govt. of India in 2013.
“Good Clinical Practices for Clinical Research in India” published
by Central Drug Standard Control Organization (CDSCO),
Directorate General of Health Services, Ministry of Health &
Family Welfare, Govt. of India and New drug and clinical trial
rules, 2019 published by CDSCO may also be referred.

47
19.3 Ethical Clearance
A certificate of clearance from the Institutional Ethics
Committee (IEC) or Institutional Animal Ethics Committee
(IAEC), as applicable is essential before initiation of the study.

20. OUTCOME OF THE PROJECT


20.1 The final technical and financial reports of each completed
study will be examined and reviewed by the local IMRAC, IMR-
IRC, which will convey its views to the IMR-PEMC for
consideration. The final outcome of the project may also be
evaluated through a PowerPoint presentation by the PI/Co-I before
the IMR-PEMC.
20.2 IMR-ISC will also give its comments on the publication of
study results and the patents claimed by the Principal Investigator
(PI). The decision of the IMR-PEMC in this respect will be final
and binding.
20.3 Deliverables will be assessed through various outcomes of the
project, such as publications in reputed journals, product
development, patents, technology developed, SOPs, and
presentations on National & International platforms which will
belong to CCRUM.
21. INTELLECTUAL PROPERTY RIGHTS AND PATENTS
21.1 The intellectual property rights (IPR) and patents generated
through the research supported by the CCRUM will be exclusively
owned by the Council as an organization. The investigator or the
staff employed on the research project shall not obtain patents for
any invention/discovery made by them. The Council will make
efforts to commercialize the product as and when applicable.

48
21.2 All raw data (in any form) should be made available to
CCRUM on the completion of the project, along with the
submission of the final report.
21.3 The Council reserves the right to undertake further research
on completed IMR projects, either with the same PI/Institute that
completed the project or with a different PI/Institute.
22. PUBLICATION
a. The PI will submit the final consolidated report as per the
format (Annexure-4) to the Council, after the completion of
the project. The CONSORT guidelines shall be referred to
wherever required.
b. Outcome of the project shall be mandatorily published in a
reputed, peer-reviewed, indexed journal (preferably with a
high impact factor), or in the form of a book, or in the
Journal of the Council, etc.
c. If the article is to be submitted to a journal other than
CCRUM, prior approval of the manuscript by the Council
Headquarters is mandatory.
d. In the case of multicentre studies, the PI of the Nodal
Institute or the Nodal Officer at CCRUM Headquarters is
responsible for coordinating with all who contributed to the
study for the planning of the publication.
e. In the case of coded formulations, CCRUM Headquarters
will regulate all patent and publication matters.
f. In the case of non-clinical projects, the decision regarding
publication will be made by the Council Headquarters on a
case-to-case basis.
g. The draft article must be submitted by the PI to the Council
Headquarters within 3 months of the acceptance of the final
report.

49
h. The assistance and funding provided by CCRUM should be
acknowledged in the research papers and publications
based on the results of the research project as and when
published. Any violation of this will be viewed seriously
and may invite penal action.
i. After publication, three copies of the article reprints must
be submitted to CCRUM Headquarters for record.
j. Expenditure on publication of the research findings in the
journals of repute shall be met from the scheme.

50
ANNEXURE – 1

CENTRAL COUNCIL FOR RESEARCH IN UNANI MEDICINE


MINISTRY OF AYUSH, GOVERNMENT OF INDIA

APPLICATION (FORMAT) FOR CCRUM INTRA MURAL


RESEARCH PROJECTS IN UNANI MEDICINE
SECTION-A
GENERAL INFORMATION

1. Title of the Research Project:

2. Institution responsible for the research project


Name:
Postal address:
Telephone:
Telegraphic address:
Fax:
E-mail:

3. In case of Individuals applying for the Research project:


(Name of the collaborating institute may be cited at S. No. 2 above)

Name of the individual:


Postal address:
Telephone:
Telegraphic address:
Fax:
E-mail:

4. Name and Designation of


i) Principal investigator:
ii) Co-Investigator(s):
iii) Consultant (s):

51
5. Duration of Research Project:
i) Period required for pre-trial preparations:
ii) Period which may be needed for generating the data:
iii) Period that may be required for analyzing the data:
6. Details of research project(s) taken up by the Institute in the last three
years (completed and ongoing) Under IMR

S.N Nam Date of Date of Total Names Statu Status of


o. e of incepti completion of Cost and s of the U.C.
the on of the Designati the
Proje project project/expect on of the Proje
ct ed date of PI and the ct
completion of Co-I
the project

7. Research Projects in hand under any other Grant-in-aid scheme of


Government of India

S. Title of the Date of Date of Names and Status


No. Project inception completion of the Designation of of the
of project project the PI and the Proje
Co-I ct

Name and Signature of the:

a) Principal Investigator(s) _________________________________


Name Signature

b) Co-Investigator(s) ____________________________________
Name Signature

________________________________________________
Name Signature

52
Signature of the Head - CCRUM Institute (Forwarding Authority)
Name:
Date:
Seal:

LIST OF DOCUMENTS ENCLOSED:


1. ________________________________________________________
2. ________________________________________________________
3. ________________________________________________________
4. ________________________________________________________
5. ________________________________________________________

53
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 (Graduation Degree Onwards)
Degree Institution
Year
6. Research Experience
Duration (From-To) Institution
Particulars of work done
7. Research specialization
(Major scientific fields of interest)
8. Financial support received
a) From the Ministry of Ayush
Past
Present
Pending
b) From other organizations
Past
Present
Pending
9. Research projects in hand under IMR
10. Research Projects in hand under any other Grant-in-aid scheme of
Government of India
11. Other research projects, if any:
12. List of five important publications of the Investigator relevant to the project,
13. Other information, if any:
Signature:
Date:

54
SECTION–C

BRIEF SUMMARY OF THE RESEARCH


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

1. Title of the Research Project:


2. Objectives.
3. 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.
4. Milestones with deliverables in the research project
5. IPR values
6. Present knowledge and relevant bibliography including full titles of
articles relating to the subject.
7. List of important publications concerned to the project (enclose
reprints).
8. Ethical and other clearances:
i. The description of ethical considerations relating to the trial is to
be mentioned and Approval of the Institutional Ethical
Committee/Institutional Animal Ethics Committee should be
enclosed for research involving human subjects/animal
experimentation. However, ethical clearance may be obtained
during the process of the approval of the project.
ii. If radio tagged material is proposed to be used in the project
either for clinical trials or experimental purposes, then clearance
from Nuclear Medicine Committee, Bhabha Atomic Research
Centre, Mumbai, should be attached.
9. Budget requirements (head wise and item wise) if any (should come
through In-charge of the Institute) in the following format attached as
Annexure-2

55
SECTION-D

Detailed Research Protocol (to be enclosed)

Give here the detailed protocol of the study including title, hypothesis,
rationale, study design, study site, inclusion & exclusion criteria, sample
size, appropriate methodology, expected outcomes, and other relevant
information as per the recent guidelines. Materials used, method of data
collection and analysis should also be discussed. 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.

(Note: The Investigators are required to go through prevalent


guidelines as applicable)

56
ANNEXURE- 2

Budget Justification

S.No Details (provide the 1st 2nd 3rd Total Justification


calculation for each head) year year year
1. Manpower requirements
2. Non-recurring expenditure
(equipments & other non
consumables if any)
3. Recurring expenditure (trial
drug & other consumable
items)
4. Travel expenses (TA/DA)
5. Contingency
Grand Total

57
ANNEXURE- 3
FORMAT FOR PROGRESS REPORT
1. Project title
2. PI (name and address)
3. Co-I (name and address)
4. Collaborating institutes
5. Other scientific staff engaged in the study
6. Non-scientific staff engaged in the study
7. Date of start
8. Duration
9. Objectives of the proposal
10. Methodology followed till end of period of reporting
11. Interim modification of objectives/methodology, if any (with
justifications)
12. Summary on progress (during the period of report)
13. Milestones with deliverables achieved during the reporting period
as proposed in the scheme
14. Applied value of the project
15. Research work which remains to be done under the project

Signature of PI:
Date:

Signature of Head of the Institute:


Date:

58
ANNEXURE-4

FORMAT FOR FINAL REPORT


1. Title of the Project:
2. PI (name and address)
3. Co-I (name and address)
4. Collaborating institutes
5. Other Scientific Staff engaged in the study
6. Non-Scientific Staff engaged in the study
7. Implementing institution and other collaborating institutions
8. Date of commencement
9. Duration
10. Date of completion
11. Objectives as approved
12. Deviation made from original objectives if any, while
implementing the project and reasons thereof.
13. Experimental work giving full details of experimental set-up,
methods adopted, data collected supported by necessary tables,
charts, diagrams and photographs.
14. Detailed analysis of results indicating contributions made
towards increasing the state of knowledge in the subject.
15. Conclusions summarizing the achievements and indication of
scope for future work.
16. Manuscript for publication (300 words for possible publication
in Council’s Bulletin).
Name and signature with date

1. ________________________ 2. _________________________
(Principal Investigator) (Co-Investigator)

Forwarded by Head of the Institute:

(Name and signature with date)

59
COLLABORATIVE RESEARCH SCHEME AT NATIONAL
LEVEL THROUGH EXPRESSION OF INTEREST (EOI)
The Collaborative Research Scheme through Expression of
Interest (EoI) for research in Unani Medicine aims to promote and
support research that enhance understanding of Unani Medicine,
its therapeutic potential and its integration into the mainstream
healthcare system. This scheme is aligned with the broader
objectives of promoting health research and scientific innovation.
Proposals exclusively focusing on Unani Medicine are considered
for financial support under this scheme.

1. SCOPE OF COLLABORATIVE RESEARCH


The collaborative research projects should focus on areas
relevant to the Unani Medicine which includes, but is not
limited to the following:
 Preclinical and clinical studies to assess the safety and
efficacy of classical/ Pharmacopoeal and new Unani
therapeutic interventions.
 Development and standardization of Unani formulations,
herbal remedies and treatment modalities.
 Research based on Unani diagnostics, preventive
healthcare strategies and lifestyle interventions.
 Clinical research on fundamentals of Unani medicine in
disease and therapy.
 Documentation, digitization, and preservation of
traditional Unani knowledge including formulations and
treatment protocols.
 Integration of Unani medicine with contemporary
healthcare practices.

60
 Investigating the role of Unani medicine in preventive
healthcare.
 Potential use of Unani therapeutics in treatment of sub-
chronic & chronic ailments.

2. THE PRIORITY AREAS OF COLLABORATIVE


RESEARCH
Presently Council encourages collaborative studies in the
following identified areas:-
A. Translating classical/clinical experience through evidence
based experimental research in the following areas.
Non-communicable health conditions:
a) Lifestyle disorders including cardiovascular diseases,
obesity and diabetes mellitus
b) Musculoskeletal disorders
c) Gastro-intestinal tract (digestive)/hepatobiliary (liver)
disorder
d) Respiratory disorders
e) Skin diseases and antiageing
f) Gynaecological disorder
g) Sexual disorders
h) Endocrine disorders
i) Cognitive disorders
j) Neurological disorders
k) Autoimmune disease
l) Health conditions originating due to radiation,
environmental pollution and climate change
Communicable conditions i.e., viral, bacterial or fungal
infections

61
B. Adjuvant therapies to counter side effects of conventional
medicines like cancer chemotherapy, anti-tuberculosis
drugs, anti-retroviral drugs, epileptic drugs etc.
C. Scientific validation of fundamentals and basic principles
of Unani Medicine
D. Safety and pharmacology of Unani drugs
E. Pharmacokinetics and Pharmacodynamics of Unani drugs
F. Exploring the mechanism of action and ascertain the
physicochemical nature of the drugs
G. Molecular and genetic co-relation studies to understand
temperament of patients, disease, diet and drugs
H. Redesigning of various dosage forms as per need and
requirement
I. Developing organ-specific immunomodulators
J. Co-opting nano techniques for Unani formulations
K. Co-opting artificial intelligence, machine learning for
various diagnostic and treatment modalities and procedure

3. COLLABORATIVE RESEARCH TEAM


 Collaborative research team should include members
with expertise in Unani medicine as well as experts
from relevant scientific and medical disciplines.
 Interdisciplinary collaboration and partnership with
research organizations, universities and Unani
medicine practitioners are highly encouraged.
 Provision for JRF/SRF/RA should be made for Unani
graduates / Post graduates/MSc in basic
sciences/clinical research as per the requirement of
collaborative project.

62
4. ELIGIBILITY CRITERIA
 Researchers from academia and scientific
organizations/ institutions including universities,
Unani medical colleges and research organizations are
eligible to apply.
 The lead investigator should have experience and
qualifications in the relevant domain of the project
proposed.
 Collaborative research involving multidisciplinary
teams is encouraged.
 The research proposal must align with the guidelines
for collaborative research scheme.
 The research proposal should have translational and
IPR valuation.
 Those professors/scientists with a remaining
superannuation period of less than 3 years are not
eligible to apply.

5. SUBMISSION OF PROJECT PROPOSALS


 Interested researchers and institutions should submit
the EoI in the format prescribed for proposal
submission (Annexure I).
 The project proposal should be submitted physically
(05 set of hard copies) and soft copy on Email ID
[email protected]; [email protected] to
the Director General, CCRUM or Program officer at
CCRUM Hqrs, Janakpuri- 110058, New Delhi. The
timelines for project proposal submission will be
communicated through official channels each year.
 The project must include the following components:

63
i. Title and objectives of the collaborative research project.
ii. Detailed research plan, including the methodology and
expected outcomes.
iii. Prior work undertaken on the project.
iv. A comprehensive budget estimate, including a breakdown
of expenses with justification. Expected timeline for the
execution of the project.
v. The structure and roles of the collaborative research team
members.
vi. EoI must be accompanied with the Biodata of PI/Co-I, not
exceeding two pages in the prescribed format (Annexure II).

6. BUDGET
The budget with justification is to be submitted in
prescribed format (Annexure III).
Budget would be sanctioned under broad sub-heads as
under:
 Staff (Pay and allowance of the staff)- as per CCRUM
norms
 Contingency (recurring (consumables) and non-recurring)
 Travel (if approved)
 Equipment (if approved, less than five lakhs only)
 Overhead charges (maximum 3% of recurring budget i.e.,
except travel & non- recurring).
 Declaration & attestation to be submitted in prescribed
format during initial submission of project-Annexure IV

7. MECHANISM OF EVALUATION, IMPLEMENTATION,


AND MONITORING
Submission and initial scrutiny: Submitted proposals
undergo evaluation by a panel of experts in Unani medicine and

64
related disciplines. Evaluation criteria encompass scientific
merit, innovation, feasibility, relevant research experience of PI
and translational value of the proposal. After internal scrutiny,
qualified proposals proceed to the next level.
Three-tier technical review: Qualified proposals are subjected
to technical review by a structured three-tier system. Project
Investigators (PIs) receive comprehensive feedback and are
advised to revise proposals, if necessary.
Project screening committees: Proposals initially screened by
the Internal Research Committee (IRC) based on the priority
areas of research.
Project Evaluation Committees (PEC): Proposals along with
reviewer comments are presented to Project Evaluation
Committees (PEC)/ Research Sub-committee (RSC) or subject
experts (SE) in respective areas. PEC/RSC/SE shall be
constituted by CCRUM consisting of renowned researchers/
subject experts/ domain experts etc. on an yearly basis or as per
the recommendation of Competent Authority. Principal
Investigators are normally called for presentation before
PEC/RSC/SE. The recommended Proposals shall be taken up
for financial support depending upon final approvals by the
Competent Authority, ratings provided by the PEC and
availability of budget after the approval of competent authority.
Scientific Advisory Committee (SAC): SAC constituted by
Ministry of Ayush serves as the ultimate reviewing body.
Proposals along with their financial implications are presented
to SAC for approval.

65
Project Monitoring Committee (PMC): Periodic monitoring is
conducted, often on-site, by Project Monitoring Committees
(PMC) and/or Group Monitoring Committees at various project
stages. PI is advised to take necessary action on the
recommendations of the committee. Project Completion
Reports (PCR) are sent to experts/PMC for comments. A
presentation is also required to be made by PI on completion of
the Project for final assessment and identification of future
course of action on the project.
In all collaborative projects, the sharing of work component,
engagement of manpower, financial liability and IPR issues
including publication, marketing etc. will be clearly
demarcated and decided before execution of the project. All the
participating institutes should strictly adhere to timelines and
deliverables as approved in the project.
In all such cases, the MoU has to be signed among
collaborating institutes to maintain non-disclosure of data and
commitment to own liabilities. A copy of the MoU should be
submitted to CCRUM along with the proposal.
8. FINANCIAL SUPPORT AND DURATION
The selected collaborative research projects will receive
financial support with the funding quantum determined based
on the project requirements. Project durations, justified in
proposals may range from 1 to 4 years and are time-bound.
9. ETHICAL CONSIDERATIONS
 Collaborative research projects involving human subjects
and animal experiments must adhere to National and
International Ethical and Regulatory Guidelines issued
from time to time.

66
 Informed consent, Ethics Committee approval and relevant
permits should be obtained before the initiation of study.
10. PROJECT MONITORING, COMPLIANCE AND
REPORTING
 Funded projects must adhere to ethical guidelines and
regulatory requirements for research.
 Regular progress reports on annual basis (Annexure V),
financial statements UC & Statement of Expenditure (SoE)
and milestones in prescribed formats (Annexure VI) should
be submitted to the Competent Authority, CCRUM within
the financial year.
 Investigators or project manpower leaving an ongoing
project should inform CCRUM and delegate full
responsibility for project execution, submit reports, and
provide utilization certificates (UC) to new PI through
proper channel.
 The Principal Investigator (PI) should collaborate with the
Co-investigator and ensure the timely submission of all
required reports.
 Progress work of projects will be screened on any working
day by PMC members to inspect the smooth functioning of
projects.
11. NON-COMPLIANCE CONSEQUENCES
Non-compliance with guidelines may result in the termination
of funding. In case of non-compliance, the funded amount
shall be required to be returned to the funding agency.

67
12. DISSEMINATION OF RESULTS
Collaborative research findings should be published in peer-
reviewed indexed and high impact factor journals and
researchers are encouraged to share their work at relevant
conferences and seminars in collaboration with CCRUM as
shared authorship, as ethically applicable, in publications.
Publication ethics should be followed.
Efforts should be made to disseminate research outcomes to
facilitate knowledge sharing.
Patents should be filed from project in collaboration with
CCRUM as per MoU provision.
13. CERTIFICATE ISSUED BY DEPARTMENT OF
SCIENTIFIC AND INDUSTRIAL RESEARCH (DSIR)
Public funded institutions do not require DSIR certificate for
applying.
Private academic institutions with valid UGC/AICTE/PCI
/NCISM or NMC-approved Medical/Unani colleges also do
not require DSIR certificate for applying.
All other institutions must submit DSIR certificate.
14. PROJECT SHORTLISTING
CCRUM will inform the PI in case the project is short-listed and is
being considered for the next stage of the process. However, this
will not indicate an assurance for funding, as funding will depend
on final selection. In case a project is shortlisted for funding, PI will
have to submit the following documents within three months of
receiving the approval letter, failing which the approval may be
cancelled. It is therefore recommended that PI may proceed to
prepare the below-listed documents to avoid non-compliance
during the specified submission time duration:

68
Declaration & Attestation (Annexure IV)
Acceptance with two hard copies of final project with revised
estimate duly signed by PI and Co-Is and forwarded by
competent authority (Annexure VII).
MoU between CCRUM and collaborating institute on Non-
Judicial stamp paper for undertaking collaborative project as
per format (Annexure VIII).
Bond on Non-Judicial stamp paper (Rs.100/-) as per format
(Annexure IX).
Institutional Ethics Committee clearance (if applicable)
/Declaration with reason if Not Applicable):
a) Approvals to be taken from the registered
IAEC/IEC of the institute (Format as per
collaborating Institute Ethics Committee).
b) Certificate issued by Department of Scientific and
Industrial Research (DSIR), as applicable.
Undertaking / Certificate as per format (Annexure X).
Pre-receipt bill as per format (Annexure XI).
Certificate regarding availability of the relevant machinery and
equipments with the institute (Annexure XII).
Mandate form of the institute for transfer of funds (Annexure
XIII).
Plagiarism undertaking for proposal (Annexure XIV)
Following documents will be asked for submission as per
requirement of the project:
Case record proforma, study instruments, questionnaires,
scales, etc
Review Committee on Genetic Manipulation (RCGM)-
Recombinant DNA technology or declaration that the same is
not required

69
Clearance from Nuclear Medicine Committee, AERB (if
using radio-tagged material)
Institutional Bio-safety Committee (IBSC) – Recombinant or
synthetic DNA/RNA/ Risk group I/II/III organisms and/ or
other biohazards
Any other additional document as per project requirements, if
applicable

15. PLAGIARISM
The project proposals before submission should be subjected to
plagiarism check by standard software. An undertaking in this
regard should be enclosed as per the prescribed format (Annexure
XIV). Plagiarized proposals are liable to get rejected.
16. AUDITORS
CCRUM would normally accept audited report from statutory
auditors. The CCRUM may also accept statement of accounts
audited by Chartered Accountants approved by or registered with
CAG and /or Ministry of Ayush. A copy of the resolution is to be
submitted if a private firm is engaged.
17. RELEASE OF GRANTS
The funds will be released in instalment once in a year. The first
instalment is released along with the sanction letter. It would
include the entire grant for non-recurring and recurring
expenditure for the entire year. Steps to procure the approved
consumables should be initiated immediately following the
prescribed norms of the host institution.
For the subsequent years, the funds will be released only after
receipt of the annual progress report of the project for previous
year along with Statement of Expenditure (SoE) duly attested
by the Accounting Authority of the institute. In order to avoid

70
break in continuity of funding, the annual report should be
submitted within 11 months of the date of sanction of project
and UC, SoE should be submitted immediately after the end of
year. If the annual report and SoE are not submitted within 1
month after the end of the year, the project is likely to be
delayed so timelines should be strictly followed.
The last year fund would be released only after receiving the
SoE and provisional UCs for the penultimate year. Last year
allocation would be after adjustment of unspent balance as per
the SoE & UC. A 10% of last year fund will be retained and will
be released only after the submission of final report, UCs and
SoE.
18. RE-APPROPRIATION OF FUNDS
Expenditure should on no account exceed the budget
sanctioned for the project. For re- appropriation of expenditure
under the different sub-heads (pay & allowances,
contingencies, consumables, equipments, etc.) within the
sanctioned budget and for unspent balance, a request may be
sent to CCRUM where re-appropriation exceeding 20% of
concerned subheads under sanctioned budget for the year is
permissible. Within this 20%, PIs will have the liberty to re-
appropriate the funds with due intimation to CCRUM.
However, the overall sanctioned budget should remain the
same.
19. DOWN GRADATION/UP-GRADATION OF APPROVED
POSTS
For whatever reasons, if an investigator would like to
downgrade or upgrade a post or convert it to an equivalent post
with another designation, the PI will have to send a request to
CCRUM with adequate justification. The justification will be

71
carefully examined by the Technical Division and if approved,
Heads of Divisions will communicate the same to the PI.
However, the PIs will have to manage such re-designations
within the budget and only after appropriate approvals.
CCRUM shall only fund for the project positions, as
enumerated in the criteria for engagement of Non-Institutional
Project Human Resource Positions, purely on temporary
contractual basis. Age relaxation beyond indicated maximum
age limit is not permissible. It may be noted that there will be
no legal binding or relation of “Employee” and “Employer”,
between the project staff and the CCRUM and no claim for any
additional emoluments, perquisites, privileges, continuation of
project services in any other ongoing project and regularization
of service against the regular CCRUM sanctioned posts, shall
be entertained.
20. DATE OF START
The date of initiation of the project will be the date when the
PI receives the grant. This date would have to be
communicated by the host collaborative Institute to the
CCRUM.
21. UTILIZATION OF TRAVEL GRANT
The travel grant can be utilized for travel by the PI, Co-I or by
Research Fellow/Associates/ Project Staff (staff) working in
the project for:
Visiting the CCRUM Hqrs Office for meeting(s) related to the
project.
Attending a training course related to project (mainly for
project staff).

72
Attending seminars/symposia/conference provided the PI
himself or the Project Staff/ Fellow/Associate is presenting a
research paper (based on the project work) which has been
accepted.
For field work /survey in respect of project related activities
International travels are not permitted under this head
22. CONTINGENCY GRANT
This is meant for recurring as well as non-recurring
expenditure. The contingency grant can be utilized for
purposes it was sanctioned by the appropriate Expert
Committee like, but not limited to:
Acquisition of books and documents of relevance to the
research topic in case these are not available in the library, these
would become the property of the Institution library and after
purchase and accession may be issued to the Department /
Scientist till they are needed.
Charges for specialized investigations for which facilities do
not exist in the host institute
Publication charges/article processing fees/ reprints/ off-prints
of research papers published as an outcome of the research.
Printing of questionnaire
Preparing software for data management or Apps for data entry
Computer utilities, charges for analysis of data(computer
charges)
Expenses in connection with the preparation of the final report
POL - Taking up field work/travel connected with the research
work (TA/DA would be as per the entitlement).
Communication Charges
Grant cannot be used for purchase of furniture items/office
equipment

73
For contingency grant exceeding Rs.25000/-per annum,
detailed breakdown should be given. All expendable and non-
expendable articles acquired for work of the project should be
purchased in accordance with GFR and with the procedure in
vogue in the host institutions. For permanent and semi-
permanent assets acquired solely or mainly out of the grant, a
separate audited record in the form of register in prescribed
Performa enclosed shall be maintained by the Institute.
23. CONSUMABLE ITEMS REQUIRED FOR RESEARCH
WORK
A detailed list of consumables proposed to be utilized in the
project should be submitted in case the project is accepted for
funding.
24. EQUIPMENT
The Council would provide minor equipment(s) for conduct of
the study provided it has been approved by the appropriate
(PEC/RSC/SE). There is upper ceiling of Rs 5,00,000/-on the
amount to be sanctioned for purchase of equipment (s). All
equipment should be purchased according to the GFR and
procedures of the institutions where the project is to be carried
out. Equipment procured through the CCRUM grant should
bear a label “CCRUM funded”. Only the equipment
recommended by the PEC/RSC/SE may be purchased from the
non-recurring head sanctioned for the project.
25. BIODATA OF PI AND CO-INVESTIGATOR
The biodata for the Principal Investigator (PI) and Co-
Investigator (Co-I) should be concise, not exceeding two
pages. To provide a brief overview of professional background
and comprehensive list of publications should be attached.

74
26. ANNUAL PROGRESS REPORT
Annual report is to be submitted annually in the prescribed
format. In order to avoid break in the continuity of funding, the
Annual report and SoE should be submitted immediately after
the end of the year.
The progress of the project would be evaluated by the CCRUM
either by peer review or by an Expert Committee (PEC/RSC).
The project will not be renewed for the next year unless the
Council receives the progress report in time.
A delay in receipt of the report in time for consideration by the
Committee may lead to delay or termination of the project.
The PI may be asked to present the progress at the meeting of
the Committee, if considered necessary.
The suggestions and views of the Committee and mid-course
correction, if any, would be conveyed to the PI from time to
time for effective conduct of the project.
On-site review may be conducted by Expert Committee
(PEC/RSC) from time to time in collaborating Institutes in
consultation with CCRUM to review the onward progress of
project. Project progress if found unsatisfactory at any stage will
lead to termination.
27. ANNUAL FINANCIAL STATEMENT
Annual Statement of Account in form of SoE as per the
prescribed format duly signed by the Accounts Officer, PI &
Head of the host institute/empanelled auditor for the project
detailing the funds received and expenditure incurred upon
completion of 11 months from date of start of the project needs
to be submitted by the PI as provisional UC for releasing the
grant for next year.
Unspent balance would be adjusted in the next year instalment.

75
28. FINAL SETTLEMENT OF THE ACCOUNTS
The final settlement of the Accounts will be done only after the
receipt of the following:
Full and final utilization certificate
Full and final audited statement of expenditure
List of minor equipments procured from the project along with
their cost, date of purchase and suggestions for disposal of all
items purchased.
The unspent balance shall be refunded to the CCRUM by the
institution at the end of the project period or as and when the
investigator discontinues the project midway or when the non-
compliance is noticed by the Committee.
29. FINAL PROJECT COMPLETION REPORT
At the completion of the project, the final report in the
prescribed format has to be submitted.
To submit following documents within three months from the
date of completion or termination of the project:
a) The final report
b) A list of articles, both expendable and non-
expendable
c) Submit all the raw data (along with descriptions)
generated from the project to the CCRUM
d) The raw data should also be stored at the PI site for
at least 5 years post completion of the project.
Submit the audited statement of accounts duly audited by the
auditors as stipulated by CCRUM.
Submit the publication copies related to the study with
acknowledgment and shared authorship as ethically applicable
with CCRUM.

76
30. EXTENSION OF THE PROJECT REQUESTS
The project extension beyond approved duration would not be
entertained routinely. However, if interesting/important leads
are likely to emerge that need to be followed up, then a valid
justification for an extension should be submitted by the PI
three months before the expected completion of the project
along with progress report, clearly mentioning the period of
extension with justification and reasons why the project could
not be completed within the stipulated sanctioned period. It can
be extended after approval of DG, CCRUM. It will not be
necessary to send the same to finance section if extension
request is within the approved budget. A proper justification is
needed and Head of the concerned division will have to prior-
approve the request before the final decision by DG, CCRUM
and Finance section, if additional budget for the extended
period is necessary, the details to which are to be provided by
the PI in his extension request.
31. CHANGE OF PI
 PIs are encouraged to also have a Co- investigator
preferably Unani physician in the project apart from allied
sciences.
 In case the PI leaves the project, an eligible Co- investigator
could be considered as the PI subject to recommendation of
the PI and the Head of the Institution. Such a request should
be sent well in advance, for approval of CCRUM along with
consent of the Co- I that he agrees to carry out the project
as per terms and conditions of CCRUM.
 In case the PI is shifting to any other institution, the Co-
investigator could be made PI or the project could be

77
transferred to the Institutions with prior approval of the
CCRUM.
 The host institution has an important role to play in the
above. The institute/ Principal Investigator will have to
inform CCRUM of any change and in consultation with
CCRUM, take steps to ensure successful completion of the
project before relieving the original Principal Investigator.
Approval of DG, CCRUM for this change is required.

32. NUMBER OF PROJECTS WITH THE PI UNDER


NORMAL CONDITIONS
 PI should only be implementing one (01) research projects
funded by CCRUM, at a given time point and two (02) as
Co-I.
 While submitting an application for a research project, the
PI should give undertaking for all the research projects
(completed, on-going).
 Fresh research proposal can be considered only after the
completion of the previous project.
33. INTELLECTUAL PROPERTY RIGHTS
All new intellectual property viz. patents, copyright, design,
etc. generated as part of the research supported by the CCRUM
would jointly belong to the Council and host institute of the PI.
All raw data should be made available/accessible to CCRUM
at the completion of the project along with submission of the
final report. CCRUM proceed with the patenting process with
applicant as PI in loop.

78
34. OVERHEAD EXPENSES
 Will be restricted to maximum ceiling of 3% of the total
recurring cost (excluding travel & equipment budget) of
the project depending upon the type of host institution.
 Overhead expenditure will not be granted on equipment and
travel allowances. In case of MoU with the institute,
overhead charges will not be granted as per norms.

The grant paid by the CCRUM shall be refunded by the


institution as and when the Investigator discontinues a project
before the end of first year or does not follow the detailed
technical programme laid down and approved, as recorded by
PEC/RSC. Also, upon discontinuation, the PI is obligated to
submit the technical report along with UC/ SoE and refund of
balance of funds.
35. PUBLICATION OF RESULTS/PRESENTATION OF
PAPERS
The research papers and publications based on the results of the
research project should acknowledge funding from CCRUM
and provide authorship as ethically applicable along with
Project ID number, proposal ID as and when published. All
authors shall abide by CCRUM publication policies and
publication ethics. CCRUM should be informed about the
paper acceptance and provided a copy of publication.

36. DATA SHARING


PI is required to submit all the raw data (along with
descriptions) generated from the project to the CCRUM. Any
sharing of data should follow the provisions of the Digital
Personal Data Protection Act 2023 and relevant policies of the
GoI.

79
COLLABORATIVE RESEARCH SCHEME AT
INTERNATIONAL LEVEL
Any international collaboration will be taken up only after
approval of Ministry of Ayush as per the norms and procedures
prevalent at the particular time.
Before undertaking any collaborative research with foreign
academic/research organization, the Memorandum of
Understanding should be signed through the Embassy/High
Commission of the collaborating country with prior approval
of Ministry of Ayush.
The expenditure for collaborative research work in foreign
country would be borne by that Country, whereas the
expenditure incurred in India would be borne by CCRUM/
Ministry of Ayush. The travel expenses of the scientists
travelling to the collaborating country from India for
implementation/monitoring of the project will be borne by
CCRUM/Ministry of Ayush whereas the travel expenses of the
scientists of the collaborating country coming to India will be
borne by the collaborating country. Local hospitality and
transportation should be borne by the respective
countries/organizations where visited.
Before any funding, the research proposal should be approved
by DG, CCRUM and Competent Authority of Ministry of
Ayush. However, for international collaborative research,
technical inputs and research drug can be provided by CCRUM
on recommendation of the Ministry of Ayush. In case of
material transfer the National Biodiversity Act and other
prevalent rules should be taken into account.

80
In all such collaboration with foreign organizations, MoU
should be signed along with Non-Disclosure Agreement to
maintain confidentiality of the data.

The ownership of the assets purchased will be decided in the


MoU.
The cost of the project will be inclusive of institutional charges.
For all such projects, there should be a joint monitoring team
involving experts from participating organization and
CCRUM/Ministry of Ayush who will periodically oversee the
research work.

In these collaborative researches, all the IPR issues including


publication will be jointly shared between organizations of
involved countries on case-to-case basis.

81
ANNEXURES
S. No Annexures Contents
1 Annexure I Format for Submission of Project Proposal
2 Annexure II Short Resume Format PI/Co-I
3 Annexure III Budget Justification
4 Annexure IV Declaration & Attestation
5 Annexure V Format for Annual Progress Report & Final
Year Progress
Report
6 Annexure VI Format for UC & SoE
7 Annexure VII Format for Acceptance with Revised
Budget/Revised
Proposal, as applicable
8 Annexure VIII MoU Between CCRUM and Collaborating
Institute on Non- Judicial Stamp Paper for
Undertaking Collaborative Project
9 Annexure IX Bond on Non-Judicial Stamp Paper (Rs.100/-
)
10 Annexure X Undertaking / Certificate
11 Annexure XI Pre-receipt Bill Format
12 Annexure XII Certificate Regarding Availability of
Relevant Machinery
and Equipment with the Institute
13 Annexure XIII Mandate Form of the Institute for Transfer of
Funds
14 Annexure XIV Plagiarism Undertaking for Proposal

82
Format for Submission of Project Proposal
Annexure- I
PART-A

1. Title of the proposed research project (up to 25


words): should be specific, concise and yet
sufficiently descriptive and informative.
2. Summary (up to 250 words): A structured
summary should contain the following subheadings:
(i) Rationale/ gaps in existing knowledge, (ii)
Novelty, (iii) Objectives, (iv) Methods, and (v)
Expected outcomes.
3. Does it cover priority areas of Collaborative
Research?
4. Area of research (Please tick one):
 Preclinical and clinical studies to assess
the safety and efficacy of Newer Unani
therapeutic interventions.
 Development and standardization of
Unani formulations, herbal remedies, and
treatment modalities.
 Research into Unani diagnostics,
preventive healthcare strategies, and
lifestyle interventions.
 Documentation, digitization, and
preservation of traditional Unani
knowledge, including manuscripts,
formulations, and treatment protocols.

83
 Integration of Unani medicine into
mainstream healthcare, emphasizing its
compatibility and synergy with modern
medicine.
 Potential use of Unani therapeutics in
treatment of sub-chronic & chronic
ailments.
5. Keywords: Six keywords separated by comma
which best describe your project may be provided.

6. Abbreviations: Only standard abbreviations should


be used in the text. List of abbreviations maximum
of ten may be given as a list.
7. Problem Statement (up to 500 words): State the
currently available information to adequately present
the problem.
8. Rationale of the Study (up to 250 words): Mention
how the research question addresses the critical
barrier(s) in scientific knowledge, technical
capability, and/or programmatic/clinical/lab
practice and its relevance to local, national and
international context with relevant bibliography.
9. Hypothesis/ research question (up to 100 words):
Please provide details
10. Study Objectives (up to 25 words/ objective):
Define the objectives clearly and in measurable
terms; mention as primary and secondary objectives
if necessary. Do not include more than 3-4
objectives.

84
11. Methodology: Include objective-wise work plan
under the following sub-headings:
 Study design
 Study site
 Methods (e.g. PICO)
 Sample size
 Implementation strategy
 Statistical analysis
 Ethical issues
12. Expected outcome/ Deliverables aligned with
research question (up to 100 words):
13. Future plan based on expected outcomes (up to 100
words):

14. Whether the study is going to generate new


intellectual property or will be in conflict with the
existing one?: Please provide details

15. Timelines with achievable targets: GANTT/ PERT


chart to be uploaded.

PART-B

1. Preliminary work done by the PI including the


source of funding (up to 250 words): Proof of
concept (if any)
2. Skill and Experience of the Research Team:
Highlight only salient points that provides

85
confidence to reviewers that team can implement the
project with quality. Include one page brief CV of PI
and Co-I-in prescribed Format- (Annexure II)
3. Institutional Support/ Facilities: Mention the
efforts made to achieve inter-departmental or inter
institutional collaboration needed for study
implementation, details of coordination between
clinical, laboratory and data management
procedures, mention:
4. Laboratory Facilities (in-vivo/in-vitro):
institutional resources such as instruments/
equipment and other physical resources available for
use in the project proposed animal house etc.
5. Budget: Budget should be as per CCRUM
guidelines available on the website. Justifications for
all sub-headings under budget (as per Format) is
to be provided in detail.
6. Conflict of Interest Declaration (if any): PI should
include a statement for conflict of declaration (if
any).
7. Additional supplementary information including
figures, tables, flow diagrams, etc can be shared as
PDF (5 MB).

86
Annexure II

Short Resume Format (PI/Co-I) (Maximum two pages)


Name: Qualifications: Designation: Institute
Date of Birth
Domain Expertise
Articles in Pub Med
(Past 10 years)
H-index
Fellow of Academies

Maximum of 10 primary research publications related to the


proposal
Publication details in Impact factor of Name of policy/
AMA style journal programme/protocol
document or patent/
commercialization of
products where cited.

(Publications as first, last or corresponding authors may be identified with


an asterisk (*))

Experience as Investigator:
Short title of Role PI/co - Funding Amount of Reference of
project (Max. investigator agency funding main
10 words) publications

87
Annexure-III
Budget Justification (Staff, Equipment,
Contingency/Consumables and Travel Allowance)
Staff/Manpower
Sl. No. Salary (As per CCRUM Project Staff
guidelines)
Justification of Staff/Manpower(each position)

Contingency
Detail Breakup with Justification
Year 1: Total Amount (e.g. 50,000) 1) Item 1: 20,000/-
(amount is just for reference) 2) Item 2: 30,000/-
Year 2: --
Year 3: --
Year 4: --

Sl. Equipmen Estimated cost (submit any documentary proof Justification


No. Name that shows projected cost such as estimate from
GeM/E-commerce/ Company website)

Travel Allowance
Detail Justification
Year 1:
Year 2:
Year 3:
Year 4

88
Overhead charges(as per rules)
Year 1:
Year 2:
Year 3:
Year 4
Grand Total

Signature of the Principal Accounts Officer of the Signature of Head of the


Investigator Institute Institute
Stamp Stamp Stamp
Date: _____________ Date: _____________ Date: _____________

89
Annexure-IV

Ref. CCRUM-Call for Application:


Title of the project:
Name of the PI:
Name of the Institute:

Declaration & Attestation

We hereby certify that:

i. We have read the terms and conditions for


CCRUM Research Grant. All necessary
Institutional facilities will be provided if the
research project is approved for financial
assistance.
ii. The equipment(s) that is being requested as part
of this project is/are not available in the
Institute/Department /or these are available and
are being used at full capacity (Strike off the
inappropriate one)
iii. The equipment(s) requested as part of this
project have not been purchased earlier from the
funds provided by CCRUM for previous
project(s) in the Institute.
iv. No utilization certificate (UC)/ statement of
expenditure (SoE) final report is pending for
earlier CCRUM project(s) under the PI and the
final report(s) for earlier projects have been
submitted.

90
v. The project has not been submitted to any
funding agency or institution other than the
CCRUM.
vi. The PI does not have more than 1 (One)
CCRUM projects at present as a Principal
Investigator and two as Co-I.
vii. We understand that CCRUM shall only fund for
the project positions, as enumerated in the criteria
for engagement of Non-Institutional Project
Human Resource Positions, purely on temporary
contractual basis. CCRUM has apprised us of
this rule and we have carefully noted it.
viii. The name of the Statutory Audit Authority of
our Institute is as follows:
[Please attach a copy of the resolution if a private firm is engaged]
ix. Registration/Unique ID no. assigned by NITI
Ayog, GoI (on DARPAN Portal) (applicable
only for NGOs):
x. CV of the investigator and Co-Investigators
is/are attached in prescribed format.

Name Signature
Date
a) Principal Investigator ________________
b) Co-Investigator(s) ________________
c) Head of the Department ________________

Signature of the Head of the Institution with seal

Date

91
Annexure-V
Format for Annual Progress Report
1. Project title
2. PI (name & address)
3. Co-I (name & address)
4. Date of start
5. Duration
6. Objectives of the proposal
7. Methodology
8. Interim modification of objectives/methodology
(with justifications)
9. Detail progress of the work carried out during the
period
10. A summary sheet of not more than two pages under
following heads (Title, Introduction, Rationale,
Objectives, Methodology, Results, Translational
Potential)
11. Research work which remains to be done under the
project
12. Applied value of the project
13. Any publications
14. Any patents applied for
15. If additional budget or staff is required for the
remaining part of the research work, please give
justifications and details.

Date:

Signature:

Designation:

92
Format for Final Report
1. Title of the Project:
2. Unique ID of the Project (provided by CCRUM)
3. Principal Investigator and Co-Investigators
4. Implementing Institution and other collaborating
Institutions
5. Date of commencement
6. Duration
7. Date of completion
8. Objectives as approved
9. Deviation made from original objectives if any, while
implementing the project and reasons thereof.
10. Field/ Experimental work giving full details of
summary of methods adopted.
11. Supported by necessary tables, charts, diagrams and
photographs.
12. Detailed analysis of results.
13. A summary sheet of not more than two pages under
following heads (Title, Introduction, Rationale,
Objectives, Methodology, Results, Translational
Potential)
14. Contributions made towards increasing the state of
knowledge in the subject.
15. Conclusions summarizing the achievements and
indication of scope for future work.
16. Science and Technology benefits accrued:
17. List of research publications with complete details:
Authors, Title of paper, Name of Journal, Vol., page,
year
18. Manpower trained in the project:

93
19. Research Scientists or Research Fellows
20. No. of PhDs produced
21. Other Technical Personnel trained
22. Patents taken, if any:
23. Products developed, if any.
24. Abstract (300 words for possible publication in
CCRUM Bulletin).

Procurement/usage of Equipment

S. Name of Make/ Cost Date of Utilization Remarks regarding


No Equipment Model Installation rate% maintenance/breakdown

Suggestions for disposal of equipment.


Name and signature with date
1. 2.

(Principal Investigator) (Co-Investigator)

94
Annexure-VI
Format for Annual Statement of Accounts/Provisional UC
(Period ..............................................................................................)
1. Sanction Letter No: ...............…………………...………
2. Total Project Cost: Rs…………………………………
3. Sanction/Revised Project cost (if applicable): Rs................
4. Date of Commencement of Project: ………....................
5. Proposed Date of Completion:
6. Statement of Expenditure: From…..........To................
S. Sanctioned Funds Expenditure Incurred Balance as Remarks
No. / Heads Allocated I II III IV on (Date)
Year Year Year Year
1. Salaries
2. Contingencies
2.1 Non-recurring
(Equipments)
2.2 Recurring
(Supplies,
Materials,
Consumables,
etc.)
3. Travel
4. Overhead
Expenses
5. Interest on
Bank Deposit
Total
Committed Expenditure (3 months):
S. No. Heads Committed Expenditure Remarks

Signature of Principal Investigator with date:


Signature of Accounts Officer with date:
Signature and Seal of Head of the Institute:

95
Format for Final Utilization Certificate

1) Title of the Project


2) Name of the Institutions
3) Principal Investigator
4) CCRUM letter No. and date sanctioning the project.
5) Head of account as given in the original sanction letter
Certified that out of Rs................................................of grants-in-aid
sanctioned during the project period …………………………………. in
favour of …………….........under CCRUM Letter No……………… a
sum of Rs……………………… has been utilized for the purpose for
which it was sanctioned and that the balance of Rs……………………..
remaining unutilized at the end of the project which has been
surrendered to CCRUM (vide cheque No..................Dated….…..).

Certified that I have satisfied myself that the conditions on which


grant was sanctioned have been duly fulfilled and that I have
exercised required checks to see that the money has been actually
utilized for the purpose for which it was sanctioned

i. The main accounts and other subsidiary accounts and


registers (including assets registers) are maintained.
ii. There exist internal controls for safeguarding public
funds/assets watching outcomes and achievements of
physical targets against the financial inputs.
iii. To the best of our knowledge and belief, no
transactions have been entered that are in violation
relevant Act/Rules/standing instructions and scheme
guidelines.
iv. The expenditure on various components of the scheme
was in the proportions authorized as per the scheme
guidelines and terms and conditions of the grants-in-aid.

96
Format for Final Statement of Expenditure
(to accompany the Final Report)
1. Sanction letter No.:
2. Total project cost:
3. (Sanctioned/revised project cost, if applicable)
4. Date of commencement of project:
5. Date of completion of project:
6. Grant revised in each year (financial):
S. Sanctioned/ Funds Expenditure Incurred Balance as Remarks
No. Heads Allocated on (Date)
I II Year III Year IV Year
Year
(1) (2) (3) (4) (5) (6) (7) (8) (9)
1. Salaries
2. Contingencies
2.1. Non-recurring
(Equipments)
2.2 Recurring
(Supplies,
Materials,
Consumables,
etc.)
3. Travel
4. Overhead
Expenses
5. Others(if any)
Total

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


Rs……………

Name & Signature Principal Investigator With date:


Signature of Competent Financial/audit authority with date:

97
Annexure-VII
ACCEPTANCE
To

The Director General


CCRUM, New Delhi 110058

Dear Sir/Madam,

1. We hereby accept the project entitled --------------------------


(CCRUM Project ID) with Sanctioned budget and Duration
of ……….. years.

2. We agree to submit Annual Report along with and Statement of


Expenditure and Provisional Utilization Certificate of the project
within three months of prescribed date, failing which the project is
likely to be terminated.

3. We agree to submit following documents within three months from


the date of completion or termination of the project:
a. The Final Report
b. A list of articles, both expendable and non-expendable
c. Submit (online) all the raw data (along with descriptions) generated
from the project to the CCRUM

4. We agree to submit the Audited Statement of accounts duly audited


by the auditors as stipulated by CCRUM.

5. We agree to acknowledge the CCRUM in all publications related to


the study.

Name and signatures of the PI

Signatures and seal of Head of the Institute

Date____________

98
Annexure VIII
Memorandum of Understanding
Title of the study………………
1.1 THE AGREEMENT
THIS AGREEMENT made and entered into on – day of –
, --, between Central Council Research in Unani Medicine, a
Society registered under the Societies Registration Act (XXI
of 1860), having its registered office at Jawahar Lal Nehru
Bhartiya Chikitsa Avum Unani Medicine, 61-65
Institutional Area opposite D-Block, Janakpuri, New Delhi-
110058 (herein after called CCRUM which expression shall
where the context so admits include its successors and
permitted assigns) of the one part.
and

……… {Hereinafter called the………..which


expression shall where the context so admits include its
successors and permitted assigns} of the other part.
2.1 PREAMBLE
2.2 WHEREAS CCRUM under its research activities conducts
various research schemes that include Clinical Verification
research, clinical research, Drug Proving, etc.
2.3 WHEREAS the CCRUM is desirous of collaborating
with the……………………. on the project entitled
“……………………………” {Hereinafter called the
PROJECT} to be carried out
at……………………………….
The period of project shall be for a duration of
… … … … … …….. Months, commencing w.e.f. … … … …

It will be a collaborative study between the CCRUM and the… … …


… … … …., the Co-ordination team, and the Investigators
in the PROJEC T shall be as given below:

99
STUDY TEAM
A. Principal Investigators
B. Investigators
C. Coordination:

Now, therefore, in consideration of the premises and mutual


covenants hereinafter contained, the parties hereto agree as follows:
3.0 SCOPE OF THE AGREEMENT
The agreement details the terms and conditions, financial
arrangements, modalities of collaboration, intellectual property
right, responsibilities and obligations of both the parties.
3.1 The second party viz … … … … … … … shall specif y its
share in contribution in the project in detail. It shall truthful ly
disclose the details of manpower, mac hiner y, equipme nts and
laboratories and its facilities available with them, w hich shall
be utilized as its contribution towards the project.

4.1 FINANCIAL AGREEEMENTS


4.2 CCRUM and Collaborating Institution shall bear the
financial inputs under its Collaborative Research
Study for the Study entitled “ ………... ” as
agreed on the basis of project approved.
4.3 Financial Support: CCRUM will provide financial support
for staff and contingencies-recurring and non-recurring as
approved for the project and duration of study according to
terms of release. (4.7).
4.4 Expenditure on monitoring of the project to be carried out by
independent experts/ institutions selected by the CCRUM
would be met by the CCRUM and expenditure for
monitoring the project by experts selected/nominated by
………………….. shall be borne by them.

100
4.5 Contingencies

4.5.1 Non-recurring: Essential scientific equipments may be


permitted as non-recurring expenditure. However, the
quantum of such expenditure will not be more the 25% of the
total budget of the project. The equipment though shall be
property of the CCRUM, but these will be used for research
for future studies too and shall be accessible to CCRUM,
whenever required and on completion of the study, all
equipment should be transferred to any nearby Institute/unit
of CCRUM for its utilization.
4.5.2 Recurring: The expenditure of recurring nature such as
financial support for staff’s salary, medicine, chemicals and
glassware’s Investigations, animals, printing and stationary,
postage, photo copying may be allowed to be purchased as a
part of the recurring contingencies.

4.6 Travelling Allowance: Travelling Allowance/Daily


Allowance (TA/DA) of the Investigators will be permitted
for attending the meetings for monitoring and field- work
within the sanctioned fund. Foreign tour will not be allowed.
TA/DA will be allowed only as per TA rules of Govt. of
India.

4.7 Certificate of Non receipt of parallel grants


The grantee Institution/individual shall furnish a certificate
to the effect that the said Institution/individual has not been
sanctioned grant for the same purpose from any other Deptt.
of Central/State Govt. or agency during the period for which
the grant has been sanctioned by CCRUM.
4.8 Release of Funds
The head-wise grant-in-aid will be released to the Head of
the Institution in installments as yearly/half-yearly as per the
study proposal. The first installment will be released along
with the sanction letter. It would include the grant for non-
recurring and recurring expenditure for a period of one

101
year/six months. The next installment would be released
after receiving the following documentation in the prescribed
Performa.
 Technical Progress Report
 Utilization Certificate & Expenditure Statement
 Mid-term appraisal by monitoring committee or
expert(s) after presentation by the Principal
Investigator/site visit report.

4.9 Maintenance of Accounts


The Institution/Individual shall open new A/c and maintain
separate account exclusively with the bank in the name of the
Institution/Individual and the same should be operated
jointly at least by two office bearers. The accounts of the
grant shall be maintained properly and separately from the
normal activities of the Institution/Individual.
The project becomes operative with effect from the date on
which the Draft/Cheque is received by the implementing
institution. This date should be intimated by the institution
authorities/principal Investigators to the CCRUM within one
month.
A set of audited statement of these accounts duly signed by
responsible officers as mentioned in para 4.10 shall be
furnished to CCRUM after utilization of the financial support
from CCRUM. Further, these accounts shall be open to
inspection by the sanctioning authority and internal audit by
the Accounts Officer of the CCRUM, whenever the grantee
Institution is called upon to do so.
4.10 Re-appropriation
Expe nditure incurred should not excee d the sanctione d
budget against one or more sub-hea ds of expe nditure such
as staff salar y, TA/ D A, continge nc y etc. within the overall
sanctioned c eiling of that study. Any excess expenditure
shall be borne by the second party viz. … … … …… …...

102
Re-appropriation of funds from one primary head to another
primary head is permissible upto 15% to cover excess of
expenditure over authorized limits provided total
expenditure does not exceed the total sanctioned budget, only
after specific return approval of first party i.e. CCRUM, New
Delhi.
No expenditure shall, however, be incurred by re-
appropriation of savings on items not sanctioned by the
CCRUM, i.e. non-consumable equipment, store etc. savings
shall also not be re-appropriated for meeting or incurring
expenditure on staff that has not been sanctioned by the
CCRUM. The institute should ensure that while submitting
the final UC & expenditure statement, the above norms shall
be strictly followed. Excess expenditure, if any, shall be
borne by Institute.
4.11 Utilization Certificate & Expenditure Statement

Utilization Certificate & Head-wise Expenditure Statement


is required to be submitted to the CCRUM immediately after
utilization of amount released duly certified and signed by
the following responsible officers:
i) UC & ES should be duly certified by the Head of the
Finance/Accounts Deptt. i.e. Finance Officer/Account
Officer, if it is a Govt. Organization/Institution whose
Accounts are being audited by Controller and Auditor
General of India (CAG) as per rule 211 (1) (2) of GFR
and duly counter signed by the Principal Investigator &
Head of the Institution; followed by an audit of the
accounts by the Accounts Officer, CCRUM, New Delhi.

ii) UC & ES should be duly certified by Chartered


Accountants (CA) for all others organization/institution
as per rule 211 (3) of GFR and duly signed by the
Principal Investigator & Head of the Institution; followed
by an audit of the accounts by the Accounts Officer,
CCRUM, New Delhi.

103
4.12 Refund of funds
Unspent Balance, if any, must be refunded to the CCRUM
through Demand Draft in favour of Director General,
CCRUM, New Delhi on completion/termination of the study,
within a period o f three months of the date of completion of
project, failing which the second party shall be liable to pay
interest at 9% per annum from due date till actual date of
refund.
The grant released by the CCRUM shall be refunded in full by
the institution along with 18% interest per annum when the
Investigator discontinuous the Study midway or does not
follow the detailed technical programs as approved.
The interest earned on financial support from CCRUM in Bank
A/c should be reported to the CCRUM and reflected in the
Expenditure Statement. The interest earned shall be refunded
to CCRUM, New Delhi or will be adjusted towards further
installment of grant.
4.13 The second party viz………………….. shall execute an
indemnity bond in the prescribed Performa in favor of
CCRUM, New Delhi.

4.14 General Financial Conditions


The entire grant should be exclusively utilized only for the
research activities for which it has been sanctioned within the
specified period. The grant will not be regarded as a subvention
towards the normal work of the Institution.
Expenditure should not exceed the sanctioned financial
support for the study.
All items (other than sanctioned by CCRUM, for the study)
i.e. basic equipment and ordinary laboratory chemicals,
glassware, furniture and other assistance, shall be provided
by the institute for the smooth working of the research study.

104
Ten percent (10%) of total sanctioned budget of the study
will be retained by CCRUM, New Delhi till satisfactory
conclusion of the study and submission of the peer-reviewed
report of study for publication in the journal(s). The second
party shall strictly comply with all codal formalities as
provided in GFR in purchase of equipments, consumables
and other items for use in the project.
The CCRUM, New Delhi reserves the right to terminate the
project at any stage, if it is convinced that the grant has not
been properly utilized or appropriate progress is not being
made.
5.1 MODALITIES OF COLLABORATION

5.2 The responsibilities of the ……………… and schedule of


fulfillment thereof shall be as per the guidelines of
CCRUM. CCRUM will provide the financial
assistance based on the project proposal submitted by
………………………………
5.3 The execution of the project will be monitored by a
PMC/RSC committee chaired by the Director General,
CCRUM or his nominee, every six months. The
Investigator(s) 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 PEC expert group who
will give their recommendation to the CCRUM.
5.4 There will be a Data Monitoring Committee (DMC)
for the PROJECT. The DMC shall consist of Scientists
nominated by CCRUM. The DMC shall review (every
six months) the progress of the PROJECT.
6.1 Responsibilities of the Institutions

6.2 Necessary Institutional facilities will be provided if the


research project is approved for financial assistance.

105
6.3 All records and reports related to the project shall be
shown and furnished to the authorized representatives of
the CCRUM or Ministry of AYUSH.
6.4 Project shall be open for evaluation of the physical
progress and utilization of funds to the discretion of the
competent authority. A periodical report of the progress of
the project shall be given by the Investigator every month.
6.5 The grantee organization/Individual agrees to submit
within one month from the date of termination of the
project, final report and a list of articles, both expendable
and nonexpendable left on the closure of the project.
6.6 No portion of the grant will be utilized for furtherance of
a political movement, prejudicial to the security of the
Nation
6.7 The grantee will not indulge in corrupt practices.
6.8 Maintenance of Stores
6.8.1 The items purchased out of the grant of the CCRUM shall
be entered in the separate stock register maintained for the
purpose and the same shall be properly kept in the store and
presented to auditors for check and endorsement, as and when
desired. The usual forms prescribed for this purpose by the
grantee institution should be used for these registers and all
purchases made in accordance with the procedure in vogue in
the institution. Only such equipment for which provision has
been made in the budget shall be purchased. All the non-
expendable articles purchased out of the funds of the
CCRUM will be the property of the CCRUM. However, the
equipment/instruments/machines, etc. purchased out of the
grant can be retained, on submission on a term and condition
laid down under 4.4.1 of this MoU.
6.7.2 General terms and conditions of appointment
Appointment will be of temporary and contractual nature for a
maximum period of the duration of the period; The staff
employed for the term of the study will be subject to the
rules and administrative control of the institute and will be
appointed in accordance with the normal recruitment rules and

106
procedures of the concerned institute. The scales of pay
allowances etc. applicable to the staff of the scheme shall not in
any circumstance exceed the limit as mentioned in the
proposal of the study. The CCRUM will not be liable to
bear any expenditure on pension/ provident fund contribution
and leave salary contribution incurred or committed by the
grantee for persons appointed on deputation from any other
organization. Allowance (CCA), Bonus, Leave Travel
Concession (LTC) and medical benefits are not admissible
to any category of project staff. If the PI to whom a grant for
a project has been sanctioned wishes to leave the Institution
where the project is based, the Institute/ PI will inform the
same to the CCRUM and in consultation with CCRUM,
evolve steps to ensure successful completion of the project,
before relieving the PI.
7.0 Completion
7. 1 The work envisaged to be done by the ----------shall be deemed
to have been successfully completed by the ------------------ (on
submission of the Final Report/fulfillment of its/their
responsibilities as detailed in their project proposal)
7.2 The PROJECT shall be deemed to have been successfully
completed on satisfaction of criteria fixed by the DMC or any
other criteria mutually agreed by the parties hereto.

8.1 RESULTS OF PROJECT


8.2 The intellectual property that is copyrights, generated in the
collaborative PROJECT shall be jointly owned by the
CCRUM and the -------------. The CCRUM will bear all the
expenditure involved in patent procedure. However, the
technology developed out of the Project is the sole property
of CCRUM and it has full rights to transfer the technology
to any Industry of its choice. If the results of research are to be
legally protected, the results should not be published without
action being taken to secure legal protection for the research
results.

107
8.3 The procedural formalities for securing and maintaining the
intellectual property rights (copyright) if any shall be the joint
responsibility of the CCRUM and the ------------
8.4 Publication: The parties shall consult each other for any
publication in respect of the PROJECT and it will be joint
publication. These publications (papers, reports etc.) shall be
in the names of Principal Investigator and research workers of
both CCRUM and ----------, wherein it will be duly
acknowledged that the work has been carried out under the
collaborative programme between the parties.
8.5 Patents: The CCRUM shall have the right to file patents in
respect of inventions/discoveries made under a
scheme/project financed by the CCRUM. The Officer-in-
Charge or the staff employed in this project shall not apply
or obtain patents for any invention/discovery made by them
without prior written approval of the CCRUM. All patents
will be registered with NRDC in the name of the Central
Council for Research in Unani Medicine, New Delhi, India.
8.6 Source Documents
8.6.1 : Photocopy of completed case records should be sent to
CCRUM Headquarters on monthly basis.
8.6.2 : At the end of the study, the original source documents
should be submitted to the CCRUM. Ho wever, a photocopy
of these documents may be kept by the PI/---------------
9.0 Confidentiality
9.1 During the tenure of the agreement
Both CCRUM and the ________________________ undertake
on their behalf and on behalf of their sub- contractors / employees
/ representatives / associates to maintain strict confidentiality and
prevent disclosure thereof, of all the information and data
exchanged/ generated pertaining to work under this agreement for
purposes other than in accordance with this agreement. Both
parties, however, retain the rights to use the R &D results
generated during the PROJECT for its own R &D programmes
without any obligation to the other.
10.0 Utilization of Intellectual Property Developed

108
10.1 The CCRUM shall have the full rights for commercially
exploiting the intellectual property generated in the allotted project

11.0 Force Majeure


11.1 Neither party
shall be held responsible for non-fulfillment of their respective
obligations under this agreement due to the exigency of one
or more of the force major events such as but notlimited to
acts of God, war, flood, earthquakes, strike, lockouts,
epidemics, riots, civil commotion, etc. provided on the
occurrence and cessation of any such events, the party
affected thereby shall give a notice in writing to the other
party within one month of such occurrence or cessation. If the
force-major conditions continue beyond six months, the
parties shall then mutually decide about the future course of
action.

12.1 Effective Date, Duration & Termination of the Agreement

12.2 These terms and conditions will be valid for a period of one
year and its extension/continuation or otherwise shall be
jointly decided by CCRUM and -------------- two months
prior to the end of above period. However, the
rights/obligations arising from the implementation of this
agreement shall survive the termination of the agreement.
12.3 The agree ment shall be effective from … …… … a nd
shall remain in force for a period of one year from the said
date. The agree ment shall terminate on the e xpir y of the
period, unless extended by both the parties.
12.4 During the tenure of the agreement, parties hereto can
terminate the agreement either for breach of any of the terms
and conditions of this agreement or otherwise by giving three
month notice in writing to the defaulting party. Failure of either
party to terminate the agreement on account of breach or
default by the other shall not constitute a waiver of that party's
right to terminate this agreement.

109
12.5 In the event of termination on the agreement vide Clause
12.3, the right and obligations of the parties thereto shall be
settled by mutual discussion; the financial settlement shall take
into consideration not only the expenditure incurred but also the
expenditure committed by the parties hereto.
12.6 The agreement arrived at between the parties for the
utilization of the intellectual property shall survive the
termination of the agreement.
12.7 That the second party shall ensure completion of the research
work within the specified period and budget indicated in the
proposal.
12.8 Any extension of the time period of the project shall be at the
sole discretion of the Director General, CCRUM, in case the
second party for reason beyond its control, is unable to
complete the project, within the stipulated period.

13 Notices
13.1 All notices and other communications required to be served
on the, under the terms of this agreement shall be considered
to be duly served if the same shall have been delivered to,
left with or posted by registered mail to the other party.
Similarly, any notice to be given to the CCRUM shall be
considered as duly served if the same shall have been delivered
to, left with or posted by registered mail to the CCRUM at
its registered address in New Delhi.

14 Amendments to the Agreement


14.1 No amendment or modification of this agreement shall be
valid unless the same is made in writing by either the parties
or their authorized representatives and specifically stating the
same to be an amendment of this agreement. The
modifications/changes shall be effective from the date on
which they are made / executed, unless otherwise agreed to.

15 Assignment of the Agreement


15.1 The rights or/and liabilities arising to any party to this
agreement shall not be assigned except with the written

110
consent of the other party and subject to such terms and
conditions as may be mutually agreed upon.

16 Arbitration
In the event of any dispute or differences between the parties
hereto, such disputes or differences shall be resolved amicably
by mutual consultations.
If such a resolution is not possible, then the unresolved
disputes or differences shall be referred for attribution, as per
the Indian Arbitration and Conciliation Act, 1996. In which,
DG, CCRUM or his nominee shall be the arbitrator, whose
decision shall be final & binding.
17 Jurisdiction
The courts at New Delhi shall have the exclusive
jurisdiction in case of any dispute between the parties

SEAL OF PARTIES

In witness whereof parties hereto have signed this agreement on


the day, month and year, mentioned hereinbefore.
For and on behalf of For and on behalf of CCRUM
………………………… …………………………
………………………… …………………………

Signature with Seal Signature with Seal


Name: Name:
Designation: Designation: Director General

Signature Witness Signature Witness


(Name & address) (Name & address)
1. 1.

2. 2.

111
Annexure IX
BOND

This bond made this the …………. day of ………,…….. between


… … …….., an association registered under the Societies Registration
Act, …….….. and having its office at ………… in the ………..
hereinafter called the ‘obliger’ (Which expression shall unless excluded
by or repugnant to the context be deemed to include its successors-in-
interest) of the First part and the President of India hereinafter called ‘the
Government’) of the Second part; WHEREAS at the request of the
obliger, the Government have sanctioned a grant-in-aid of ………..
vide their letter …….. (hereinafter referred to as the said letter) which
forms an integral part of these presents and a copy whereof is annexed
hereto and marked with the letter ‘A’ for the purpose of and on condition
of the obliger executing a bond in favour of the Government on the terms
and conditions and the manner hereinafter contained which the obliger
has agreed to do.
Now, this Bond Witnesseth and it is hereby agreed and declared as
follows:
1. That the obliger shall utilize the said grant-in aid of …… only
for the purpose of specified in the said letter and for no other
purpose whatsoever.
2. That the obliger shall abide by all the terms and conditions
specified in the said letter and the General Financial Rules
1963 and any orders or instructions that may be issued by
Government from time to time.
3. That in the event of any failure on the part of the obliger to
abide any of the terms and conditions of the grant-in-aid
specified in the said letter or his committing any breech
thereof, the Government will be at liberty to order the
obliger to repay in full (forthwith entire grant-in-aid
amounting to ………… only or any part thereof with
interest thereon at the rate of six percent (6%) per annum
and any order made by Government in this respect will be
final and binding on the obliger and on receipt of the said
order of the obliger forthwith and without any objection pay
to the Government such sum not exceeding a sum of

112
………. only plus interest thereon as may be fixed by the
Government and the decision of the Secretary to the
Government of India in the Ministry of Health and Family
Welfare about the amount so to be paid shall be final and
conclusive.
4. The society/trust agrees and undertakes to surrender/pay to
the Government the monetary value of all such pecuniary or
other benefits which it may receive or derive/have received
or derived through/upon unauthorised use (such as letting
out the premises for adequate or less than adequate
consideration or use of the premises for any purpose other
than that for which the grant was sanctioned) of the
property/building/created/acquired /constructed largely
from out of Government grant. The decision of the Secretary
the Government of India in the Ministry of Health and
Family Welfare as regards to the monetary value afore
mentioned to be surrendered/ paid to the Government of
India will be final and binding on the Society/Trust.
5. Upon the obliger utilising the grant-in-aid only for the
purpose specified in the said letter and abiding by fulfilling
and performing all the terms and conditions of the said letter
the above written obligation shall be void and no effect but
otherwise it shall be and remain in full force effect and
virtue.
PROVIDED always and it is hereby agreed and declared that the
decision of the Secretary, Ministry of Health and Family Welfare
as to whether the obliger has or has not performed and observed
the obligations and conditions herein before receive shall be final
and binding.
6. The stamp duty on the bond shall be borne by the
Government INWITNESS whereof these presents have
been signed by … … … . and … … … … … . . for and
on behalf of the obliger and ………………..for and on
behalf of the President of India on the dates appearing
against their respective signatures.

113
Signed by:

1. Name…………………….. Dated ….............and


2. Name…………………….. Dated ….............

1. Signature…………………
2 Signature…………………

1. Witness
Name and Address

2. Witness
Name and Address

Signed by ………………………….dated…………………….for and


on behalf of the President of India in the presence of:

Signature…………………

1. Witness
2. Witness

(Each page of the bond has to be signed by the two office bearers
of the institution who are authorised to operate upon and bind its funds).

114
Annexure X
Undertaking

PROFORMA FOR UNDERTAKING/CERTIFICATE


To
The Director General,
Central Council for Research in Unani Medicine
(CCRUM) New Delhi

Subject: Release of grant-in-aid under the EoI Scheme for


Collaborative Research of Undertaking/certificate/pre-stamped
receipt-reg.
Sir,
With reference to your letter No …………..………dated ……..…….
Sanctioning Rs .……………… (In words) as 1st instalment of grant-in-
aid under the EoI Scheme for Collaborative Research for undertaking
the research project titled “………………………….”, I hereby submit
the following undertaking/certificate/document:
1. The terms and conditions of grant-in-aid are acceptable to
this Organization;
2. It is certified that Organization is not involved in any
proceeding relating to the accounts or conduct of its office
bearers;
3. Being Non-Governmental Organization has executed
necessary bond;
4. A pre-stamped receipt is enclosed herewith.

It is requested that necessary crossed Demand Draft may be issued in


favor of at the earliest.

Signature of PI with date and Stamp

Signature of Registrar/Finance Officer/Head of


Department/Principal/Dean

115
Annexure XI
Pre-Receipted Bill
PRE- STAMPED RECEIPT

Received Demand Draft No. ………………………. dated for Rs.


(Rupees…………………………. only) from the Central Council for
Research in Unani Medicine (CCRUM), (Ministry of AYUSH,
Government of India) towards 1st instalment of grant-in-aid under the
Collaborative Research Programme with CCRUM for undertaking
the research project titled “……………………………………………”

(Signature of the Head of the Organization with official seal)

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 “………………………………………………………….”
To the Principal Investigator (Name)……………………………..of
…………………………………………….. (Name of the Institute).

Signature of Signature of Signature of


Principal Investigator Co-Investigator Head of the Institution
with date & Seal with date & Seal with date & Seal

116
Annexure XII
Certificate Regarding Availability of the Relevant Machinery
and Equipment with the Institute
(On Institute letter head)

Date:

This is to certify that …………………………. [Institute Name],


located at……………………………………. [Institute Address],
has the necessary machinery and equipment available to support
the successful completion of the project titled
"……………….…[Project Title]", funded by Central Council for
Research in Unani Medicine (CCRUM), New Delhi

Details of Available Machinery and Equipment:

Name of Quantity Model/Specification Condition


Equipment/Machinery
[Equipment/Machinery 1] [Quantity] [Model/Specification] [Condition]
[Equipment/Machinery 2] [Quantity] [Model/Specification] [Condition]
[Equipment/Machinery 3] [Quantity] [Model/Specification] [Condition]

The listed equipment and machinery are in good working condition


and are readily available for use in the project. Our institute is
committed to ensuring that these resources are maintained and
accessible to facilitate the successful execution of the project
objectives.

Signature of Principal Investigator with date & Seal


Signature of Head of the Institution with date & Seal

117
Annexure-XIII
Mandate form of the Institute for Transfer of Funds
Electronic Clearing Service (Credit Clearing) / Real Time Gross
Settlement (RTGS) Facility for Receiving Payments
Detail of Account Holder (in capital latters):
1 Name of Account Holder
2 Complete Contact Address
3 Telephone Number / Fax / Email
4 Name & Address o f Project Investigator
5 Title of The Project

Bank Account Detail (in capital latters):


1 Bank Name
2 Branch Name w ith Complete Address, Telephone Number
and Email
3 Whether the Branch is Computerised?
4 Whether the Branch is RTGS Enabled? If Yes, Then What is
the Branch’s IFSC Code
(i) Is the Branch also NEFT Enabled?
(ii) Type of Bank Account (Only Saving Bank Account/
Interest-Bearing Account)
(iii) Complete Bank Account Number (Latest)
(iv) MICR Code of Bank
(v) Copy of PFMS Mapped Vendor Details (For Govt
Institutes)

I hereby declare that the particulars given above are current and
complete. If the transaction is delayed or not effected at all for reasons
of incomplete or incorrect information, I would not hold the user
Institution responsible.
(Signature & Seal of Project Investigator)
(Signature of Accounts Officer of the Institute)
Date: …………….

118
Annexure-XIV
Plagiarism Undertaking
To

The Director General


CCRUM, New Delhi

Sir
I……………………. hereby certify that the research proposal
titled ……………………………………submitted for possible
funding by CCRUM, New Delhi is my original idea and has not
been copied/taken verbatim from anyone or from any other
sources. I further certify that this proposal has been checked for
plagiarism through a plagiarism detection tool i.e. ……………………
and the contents are original and not copied/taken from any one or
many other sources. I also declare that there are no plagiarism
charges established or pending against me in the last five years. If
the funding agency notices any plagiarism or any other
discrepancies in the above proposal of mine, I would abide by
whatsoever action taken against me by CCRUM, as deemed
necessary.

Signature of PI with date

Name / designation

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