ccrh research policy - Central Council for Research in Homeopathy

CCRH Research Policy
CCRH RESEARCH POLICY
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
(An Autonomous Organisation under the Ministry of Health and Family Welfare, Government of India)
Jawaharlal Nehru Bhartiya Chikitsa Avum Homoeopathic Anusandhan Bhavan,
61-65, Institutional Area, D-Block, Janakpuri, New Delhi-110058
Email: ccrh@del3.vsnl.net.in Web: www.ccrhindia.org FAX: 91-11-28521060 Tel 28525523, 28522651
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CCRH Research Policy
1. Introduction
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
“Homoeopathy is the latest and refined method of treating patients-economically and nonviolently
Government must encourage and patronize it in our Country”.
Mahatma Gandhi, the Father of Nation
The health of a nation is an essential component of development, vital to the nation‟s
economic growth and internal stability. Assuring a minimal level of health care to the
population is a critical constituent of the development process. Since Independence, India
has built up a vast health infrastructure and health personnel at primary, secondary, and
tertiary care in public, voluntary, and private sectors. For producing skilled human resources,
a number of medical and paramedical institutions have been set up by Ministry of Health and
Family Welfare, Government of India which includes Indian Council of Medical Research
(ICMR), Department of Science and Technology (DST), Council of Scientific and Industrial
Research (CSIR). Besides these a separate Department of AYUSH has been set up for
Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy. .
The forthcoming World Health Report (2012) also has its theme, “No Health without
Research” Despite overall gains in health since Independence in 1947, in many instances,
health inequities between rich and poor have widened. Newer and re-emerging diseases
have undermined gains, and accidents, injuries, mental health problems as well as noncommunicable
diseases pose new and greater challenges.
The National Population Policy 2000 and National Health Policy (NHP) 2002, Ministry of
Health and Family Welfare, Govt. of India, National Health Policy on AYUSH 2002
emphasizes on re-orientation, prioritization of research in AYUSH and to validate therapy
and drugs in chronic and life style related diseases. According to National Commission on
Macro-economic and Health, Ministry of Health and Family Welfare, Govt. of India
(September 2005), the health conditions and disability - adjusted life years (DALYs) lost in
India results from communicable diseases, reproductive and child health conditions and life
style related disorders. The National Health Policy of AYUSH also emphasized the need for
a meaningful phased integration of Indian Systems of Medicines with the modern medicines,
and also outlined the need to secure complete integration of all plans for health and human
development, particularly agriculture and food products, rural Development, education and
social welfare, housing, water supply and sanitation.
There is a resurgence of interest in holistic systems of health care, especially, in the
prevention and management of chronic lifestyle related non-communicable diseases and
systemic diseases. Health sector trends suggest that no single system of health care has the
capacity to solve all of society‟s health needs. India can be a world leader in the era of
integrative medicine because it has strong foundations in Western biomedical sciences and
an immensely rich and mature indigenous medical heritage of its own. Besides this India has
a vast reservoir of practitioners in the Indian Systems of Medicine and Homoeopathy, who
have undergone formal training in their own disciplines. The possibility of using such
practitioners in the implementation of State/Central Government public health programmes,
in order to increase the reach of basic health care in the country, is addressed in the NHP-
2002.
One of the key challenges facing the AYUSH systems is generating data on scientific
validation on the safety and efficacy of classical formulations. On this task rests the
credibility and quality of practice of the profession and scope for functional mainstreaming
with National Healthcare system. Even though this goal of clinical validation has been
identified by the Department as early as 2002, however some achievement has been made
but needs much more to do on these lines.
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CCRH Research Policy
In order to create acceptable scientific evidence on Homoeopathic medicines, a mission
approach involving talented individuals, academic institutions (Homoeopathic and modern
medical institutions), research organizations (ICMR, DST, DBT, and CSIR etc.),
homeopathic pharmaceutical industry and CCRH Units/Institutes through a clearly
defined Research Policy in a functionally efficient manner needs to be adopted. CCRH being
the premier autonomous organization under Department of AYUSH, Ministry of Health and
Family Welfare, Government of India, would act as beacon light would prioritize research
areas and to initiate good quality research studies by the Council as well as other
organizations of repute.
2. Current status of research in India
2.1. Activities and achievements
Medical research is a broad discipline. The era of medicine in homoeopathy begins with
Hahnemann, the founder of Homoeopathy. Among all the different types of research, clinical
trials form a key step to prove the safety and efficacy of the therapy and form the bridge
between research and clinical practice. Clinical Research plays a major role in the
development of medicine. It has been more so in case of Homoeopathy wherein
symptomatic data obtained systematically by means of proving (experimentation) of drugs
on healthy human beings, need to be repeatedly verified on patients in the clinics, to be valid
before it forms part of the Homoeopathic Materia Medica. It also helps in the elucidation of
fundamental principles and their application in the treatment of various diseases. It has
therefore, remained an important research activity of the Council ever since its inception in
1978.
The main objectives of CCRH in Clinical research are clinical confirmation of drugpathogenesis;
and to evaluate action of Homoeopathic drugs on any given pathological
conditions. The programmes were initiated with pre designed protocols and laboratory
parameters for outcome assessment on scientific lines.
Some of the clinical studies undertaken at the time of inception of the Council were
continued for over a decade due to the prevalence of diseases in those areas. All studies
undertaken during 1979 were concluded except diseases of national importance as per the
decision of Scientific Advisory Committee (SAC) in 2003, so that new evidence based
studies could be initiated. The outcome of thirty studies out of these has already been
published in Clinical Research Series I, II & III. Besides this Council‟s achievements are
published from time to time both nationally and internationally. The positive gain of these
findings is that the profession will now have a smaller number of homoeopathic medicines to
refer to for a particular disease and the scope of conducting further research in these
diseases.
Successively, in 2005 Council undertook multicentric clinical studies to ascertain therapeutic
utility of a smaller group of medicines on the protocols developed in consultation with the
experts in respective fields from All India Institute of Medical Sciences (AIIMS), Indian
Council of Medical Research (ICMR), National Institute of Communicable Diseases (NICD),
National AIDS Control Organization (NACO) and eminent homeopathic Educators and
Researchers. These studies were carried out at its Institutes/Units situated at both general
and tribal areas. Further in June 2009 Council initiated 7 RCTs These studies have been
concluded and the outcomes are being published in National and International peer
reviewed Journals. Presently 14 RCTs are in the process of initiation.
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CCRH Research Policy
2.2. Strengths of Homoeopathy
1. No known side effects of medicines or resistance to medicines as reported for
antibiotics.
2. Easy mode of administration and palatability of homoeopathic medicines and
therefore better treatment adherence particularly in children.
3. Efficacy of homoeopathic medicines has been elicited in 44% randomized controlled
trials.
4. Most comprehensive systematic reviews of RCTs in homeopathy (individualised or
standardized treatment) have concluded there is evidence that the homeopathic
intervention differs from placebo treatment.
5. Patient reported effectiveness: An observational survey of over 6,500 patients over a
6-year period conducted by Bristol Homeopathic Hospital. 70% of follow-up patients
reported improved health, 50% reported a major improvement.
6. Observational studies consistently report highly positive effects.
7. Although the mechanism of action remains elusive, the results of scientific studies
indicate that homeopathy shows physical, biochemical and clinical effects sufficient
to classify it as a therapeutic agent in its own right, warranting pursued clinical and
fundamental research.
8. Although early pathogenetic trials (drug proving) have been criticized for their lack of
scientific rigour, results from recent studies such as Mollinger et al strongly indicate
that homeopathic medicines create remedy specific symptoms in healthy volunteers.
9. Encouraging results from animal and plant studies exists are also in favour of
homoeopathy.
10. In-vitro studies have shown evidence strongly suggesting that homeopathic
preparations have an effect on cell lines and on biochemical reactions.
11. Molecular system: These experiments measure the effect homeopathic preparation
have on enzymatic reaction. The majority of high-quality investigations (7/9) in this
field have reported positive results.
12. Cost effectiveness of homoeopathic therapy.
13. Lack of diagnosis of the patient is not a hindrance for treatment.
14. Aims at the individual patient, and not merely at disease only.
15. Holistic approach towards patient‟s complaints.
16. Has found to be beneficial in preventive effect in the epidemics.
2.3. Limitations of Homoeopathy
1. Most of the current criticism of homeopathy hinges upon the fact that no
adequate explanation for the phenomenon behind the action of homoeopathic
medicines.
2. Many areas of research in homeopathy are not well developed enough to provide
strong evidence.
3. Lack of funding for high end research.
4. Lack of interest among the basic researchers to investigate Homoeopathy.
5. Lack of suitable tools/research design to investigate Homoeopathy.
6. Limited role of Homoeopathic treatment in end stage disease where vital signs
are at stake.
7. Limited role of Homoeopathic treatment in disease which require emergency
management for saving life and where surgery is immediately warranted.
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CCRH Research Policy
3. Strategic vision for Homoeopathic Research in India
In 1969, the Government of India established the Central Council for Research in
Indian Medicine and Homoeopathy (CCRIMH) for conducting systematic research in
respective fields. In 1978, the CCRIMH was dissolved to pave way for the constitution of four
separate research Councils, one each for Homoeopathy (CCRH), Ayurveda and Siddha
Medicine (CCRAS), Unani Medicine (CCRUM) and Yoga & Naturopathy (CCRYN). Such
independent set-up of the Councils facilitated the promotion of research in the respective
disciplines, on their own strengths.
The Central Council for Research in Homoeopathy (CCRH) was formally constituted
on 30 th March 1978, as an autonomous organization and was registered under the Societies
Registration Act XXI of 1860. It was, however, in January 1979, that the Council started
functioning as an independent autonomous organization which is at present working under
Department of AYUSH, Ministry of Health and Family Welfare, Government of India.
3.1. Vision
To develop Homoeopathic system of Medicine on Scientific footing.
3.2 Mission
- To improve the quality of Research in the Homoeopathic System of Medicine.
- To conduct high quality research for scientific validation and global acceptance.
- To mainstream Homoeopathy at grass root levels in the Health Care System.
3.3. Functions
1. Conducting good quality clinical trials based upon international guidelines for
Research in Homoeopathy.
2. Enriching the therapeutic knowledge of Homoeopathic medicines through drug
proving and clinical verification research with prime focus on indigenous drugs.
3. Taking up work on standardization of drug substances to ensure safety and quality of
medicinal substances.
4. Strengthening and up gradation of units/institutes as Centres of Excellence in
Homoeopathy.
5. Investigation of outbreaks of epidemics and genus epidemicus as preventive
medicine.
6. Collaboration with Institute of excellence at national and international level in
Homoeopathy or allied scientific fields for basic and fundamental studies in
Homoeopathy
7. Capacity building of research scientists of CCRH for advancement in research
studies through medical innovations.
8. Promoting fellowship program for Council‟s Scientists as part of Human Resource
Development.
3.4. Objectives
- To formulate the aims and patterns of research on scientific lines in Homoeopathy.
- To invest in Drug research for standardization, safety and quality of Homoeopathic
medicines
- To collaborate with institutes of excellence towards promotion of Homoeopathy.
- To propagate research findings to the profession and public.
- Strengthening of infrastructural development of Institutes for quality research
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CCRH Research Policy
3.5. Aspirations
The strategic road map aims at charting out the directional path and contours of the
organizational structures and process required to achieve the vision set for 12 th plan. The
road map accordingly dilates on following aspects namely.
To promote quality research in Homoeopathy with the objective of validating the system
scientifically, i.e. safety and efficacy of Homoeopathy remedies.
To promote validation of fundamental principles of Homoeopathic System.
Encourage development of new drugs for high priority diseases of national importance.
Preservation through documentation of local health traditions and folklore.
Promote inter systems and inter-disciplinary research.
Protection of intellectual property rights (IPR) in AYUSH systems.
Encourage research in preventive promotive health through Homoeopathy.
3.6. Operating Principles
3.6.1 Research Plan
The CCRH is responsible for Planning and conducting research on the guidelines of
Government of India aligned with Five Year Plans .
3.6.2 Priority setting
Priority of research will be based on the previous researches undertaken by the Council /
individual and based on National Health Programmes relevant to national and local needs
based on following principles:
Responsiveness
Current and emerging issues such as demographic and epidemiologic transition,
emerging scientific developments such as modern biotechnology (genomics, human
genetics, new drug development, stem cell research), health system research, health
economics, behavioural and social issues, emerging and re-emerging infections, etc. and
the priorities of the National Health Plan will guide the research agenda.
Integration
The integration of the Research Plan with the priorities and aspiration of society is
essential for research. The linkages of the health system with communities, district and
state governments and the central government is essential for developing the data bases
for further research .
CCRH Research linkages and utilities
Health research, in addition to providing health to the community, encompasses
education, industries, environment, ecology, social and behavioural sciences,
population, agriculture, trade, commerce, in addition to the physical, chemical, biological
and mathematical sciences. This multidisciplinarity will be reflected in the Research Plan.
This will lead to meaningful health policies, plans and programmes and to make
medical technology useful and accessible to the community, for which it will be essential
to understand the community's perception of health problems, health services and health
care providers. Social and behavioural sciences and health economics are integral to
Health research and will be actively fostered.
3.6.3 Role of Private sector in health research
The role of private sector, pharmaceutical industry, biotechnology and biomedical
technology oriented Industries, private educational institutions, hospitals and nursing
homes, research foundations and institutions, private practitioners, NGO's and CBO's
working on a not-for-profit basis etc. are now major stake holders in health care research
and delivery. The Health Research System recognizes their important role in health
research and shall foster their participation in the system as partners of CCRH.
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CCRH Research Policy
3.6.4 International Collaboration
In the current global scenario international collaborative efforts are recognized as one of
the factors in successful research because of the complimentarily of technology
transfer, capacity building and access to diseased populations. Currently CCRH is
collaborating internationally with UCLA, WHO, and ISCHI. Linkages with international
developmental partners and WHO and other UN agencies shall be further developed
and strengthened to ensure that India plays a legitimate role as an emerging economy.
3.6.5 Ethical research
The Research studies conducted on Human/animal subjects should follow the prevalent
statutory, ethical and research guidelines prevalent in India (ICMR, GCP guidelines of
India) and internationally (ICH Good clinical practice, Helsinki Declaration) and the
collaborating centres and these trials should be registered with Clinical Trial Registry of
India (CTRI).
3.6.6 Monitoring and evaluation
To ensure that resources are used efficiently and in line with agreed priorities there is a
need for continuous monitoring and evaluation. The CCRH will develop explicit policies
and procedures for reviewing proposals, and for monitoring and evaluating the output and
impact of those that are funded as well as its own studies conducted centrally.
3.7. Currently identified research priorities
CCRH is conducting research under following programmes since its inception:
3.7.1 Drug Standardization- Standardization studies of Drug substances and ensuring
safety and quality of medicinal substances is a continuous effort in any therapeutic regimen.
The Council has been conducting the Drug Standardization Program since its inception. The
program envisaged a multi-disciplinary approach towards standardization and quality control
of Homoeopathic drugs. Council has been providing information on standards drawn on
homoeopathic drugs to Homoeopathic pharmacopoeia committee for inclusion as
monographs in the HPI. There is need to augment this activity in the light of utilization of
modern technological advancements for analytical studies.
3.7.2 Drug Proving- Proving of a drug substance in Homoeopathy is a unique process.
Unlike modern medicine where animal experimentation forms the basis of evolution of drug
pathogenesis, homoeopathic medicines are proved on healthy human volunteers, on both
sexes, including controls, in non-toxic doses. After the proving the drugs are put to clinical
verification for their therapeutic usefulness. In view of Indian Government‟s thrust on
indigenous drug material, more drugs made from flora and fauna of Indian origin, shall be
focused.
i. Indigenous plant material
ii. Mineral resources as yet not proved anywhere in the world or mentioned in the
literature.
iii. Thorough proving of Nosodes (including Bowel Nosodes), Sarcodes and
Imponderabilia.
iv. Proving of Drugs used in other systems of medicine, after being prepared in
Homoeopathic way.
3.7.3 Clinical Verification-Clinical Verification is an important milestone to develop reliable
Materia Medica. A symptom that is verified clinically becomes more reliable compared to the
one appeared in proving.
3.7.4 Clinical Research – Clinical research is a branch of medical science that determines
the safety and effectiveness of medications, devices, diagnostic products and treatment
regimens intended for human use. These may be used for prevention, treatment, diagnosis
or for relieving symptoms of a disease. Clinical research in Homoeopathy is complementary
to the Drug Proving and goes a long way in establishing clinical validity of the data collected
during proving of such drugs on healthy human beings. Clinical studies also facilitate
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CCRH Research Policy
assessment of therapeutic utility of drug substances in specific disease conditions thereby
prompting their proper and optimum therapeutic use. In short, clinical studies on a targeted
population of patients form an integral part of the development of therapeutic agents.
3.7.5 Literary Research: Literary research involves the use of texts and documents as
source. Literary research is the use of outside sources to support the viewpoint or argument
of an academic work. The process of documentary research often involves some or all of
conceptualizing, using and assessing documents.
3.7.6 Grant –in-aid/ Collaborative Research: Research under these heads is conducted
with institutes of repute being sponsored by CCRH.
3.7.7 Currently identified research areas
The research priorities which are detailed below relates to the above mentioned
programmes:
3.7.7.1 Fundamental Research
i. Action of Homoeopathic medicines
ii. Scientific explanation of Homoeopathic principles
iii. Scientific explanation of Homoeopathic potencies in Ultra high dilutions
3.7.7.2 Drug Research and Development
a. Drug Standardization and Quality Assurance
Pharmacology [In-vitro & in-vivo methods]
Biomarker based Mechanism of action
b. Drug Proving
c. Ethno-medical Research
Survey and documentation of medicinal plants/practices etc.
3.7.7.3 Clinical Research
3.7.7.3.1. To conduct RCT studies in Clinical research wherever there is a positive outcome
in controlled/observational studies and published in peer reviewed journals.
a) Eczema
b) HIV infection
c) Cervical spondylosis
d) Dysmenorrhoea
e) Menopausal syndrome
f) Gastroenteritis
g) Filariasis
h) Diabetic polyneuropathy
i) Trigeminal neuralgia
j) Male infertility
k) Acute febrile infections
l) Vitiligo
m) Low back pain
n) Psoriasis
o) Autism
p) Diabetic foot ulcer
q) Urolithiasis
r) Irritable bowel syndrome
s) Post-operative management (ileus, pain, healing, psychological
complaints)
t) Rheumatoid arthritis
u) Uterine fibroid
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CCRH Research Policy
v) Attention Deficit Hyperactivity Disorder
w) Schizophrenia
x) Depressive episode
3.7.7.3.2 To conduct observational studies in the areas where Homoeopathy has strength
but no scientific and methodological research has been carried out.
a) Leptospirosis (prevention and treatment trials)
b) Learning disabilities in children
c) Hepatitis
d) Candida infections
e) Impetigo
f) Verruca
g) Alopecia areata
h) Abnormal vaginal discharge
i) Fibroadenoma
j) Cancer- Palliative care
k) Lumbar spondylosis
l) Adolescent health problems
m) Malaria
n) Reproductive and Child Health disorders
o) Thyroid disorders
p) Gastro esophaegeal reflux disease (GERD)
3.7.7.3.3. To conduct exploratory studies in the areas where other systems have a limited
role.
a) Multi Drug Resistant Tuberculosis
b) Japanese encephalitis
c) Cancer
d) MDR Leprosy
e) PCOD
f) Kala-Azar
g) Epidemics
h) Swine flu
i) Gout
j) Diabetes
k) Hypertension
l) Anxiety disorder
3.7.7.4 Literary Research; Survey, collection, transcription / translation and preparation of
classical literature and text books, Medico-historical investigations of Homoeopathy
3.7.7.5 Veterinary Research
3.7.7.6 Agricultural Research
3.8. Formulation of new research designs and tools as per need of Homoeopathic Science.
3.9. Any other Areas mentioned in the project proposal/ recommended by PEMC/Scientific
Advisory Committee.
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CCRH Research Policy
The Research policy CCRH will comprise of four schemes as mentioned below:
A. CCRH RESEARCH SCHEME- A: Intra Mural Research which is centrally initiated
from headquarters will have centralized funding. These may be Unicenter /multicenter
trials for which Director General will be the Chief coordinator, Deputy Director
as co-chief Coordinator, one Lead Investigator, one Co-lead Investigator at CCRH
Headquarters and Investigator(s) at Institute(s)/Unit(s) under CCRH. (Annexure A).
B. CCRH RESEARCH SCHEME- B: Intra Mural Research with funding to individual
scientist, who are permanent technical employees (Research Officer and above) of
the Council and monitoring will be done by Headquarters (Annexure B).
C. CCRH RESEARCH SCHEME- C: Funding will be provided to individual scientist,
who are permanent technical employees (Research Officer and above) of the Council
or to the collaborating Institute as per the requirement of the study. In these Intra
Mural Research studies to be conducted in collaboration with other Institutes of
repute, the permanent employee of the Council will be one of the Investigators and
monitoring will be done by Headquarters (Annexure C).
D. CCRH RESEARCH SCHEME- D: Funding will be provided to the Organization
applying for conducting the study, where the role of CCRH will be for funding and
monitoring only (Annexure D).
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CCRH Research Policy
GENERAL GUIDELINES FOR ALL SCHEMES
Clinical validation of homoeopathic medicines can be done which are described in
Homoeopathic Pharmacopoeias and other classical texts. Various clinical research
designs adhering to standard procedures should be followed. The control arm could be a
known modern medical therapy/drug or other AYUSH systems of medicine/placebo. In
certain conditions, in which RCTs are not possible, other appropriate research trial designs
should be considered according to international standards.
Study design: Designing and developing rigorous integrated protocols (incorporating
holistic approach of intervention (lifestyle, diet etc.) and holistic assessment parameters
incorporating Homoeopathic Principles and approaches with adequate sample size and
statistical power) for RCTs in consultation with Homoeopathic experts, modern medical
experts, epidemiologists, clinical pharmacologists and Bio-statisticians. This design aims at
assessing the efficacy of Homoeopathic system of medicine in comparison to conventional
medicine/other AYUSH systems.
In Phase I trials, researchers test an experimental drug or treatment in a small group
of people (20-80) for the first time to evaluate its safety, determine a safe dosage
range, and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group
of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of
people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to
commonly used treatments, and collect information that will allow the experimental
drug or treatment to be used safely.
In Phase IV trials, post marketing studies delineate additional information including
the drug's risks, benefits, and optimal use.
Statutory, Ethical and Research guidelines: Clinical trials should follow the prevalent
statutory, ethical and research guidelines prevalent in India and the collaborating centres
and these trials should be registered with Clinical Trial Registry of India (CTRI).
Procurement of trial drugs: Trial drugs for the projects will be procured from reputed GMP
compliant manufacturers.
Participating Centers: Research will be carried out at CCRH Institutes / units, reputed
Homoeopathic and modern medical institutions, governmental & non-governmental
research organizations.
Monitoring and evaluation: CCRH may engage experts from scientists in the field of
homoeopathy and experts of allied discipline and other sciences to evaluate and monitor the
progress of the projects for all the schemes.
BENEFIT SHARING: Sharing of (a) monies realized from licensing of Intellectual Property
and (b) the intellectual fees from contract R&D and (c) S&T Services, with the staff as per
guidelines/procedures for sharing or monies realized from licensing of Intellectual Property,
and fees from contract R&D and S& T Services adopted by CSIR (Annexure 2)
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CCRH Research Policy
GUIDELINES FOR SCHEME - A
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Annexure A
Intra Mural Research which is centrally initiated from headquarters will have centralized
funding. These may be Unicenter /multi-center trials for which Director General will be the
Chief coordinator, Deputy Director as co-chief Coordinator, one Lead Investigator, one Colead
Investigator at CCRH Headquarters and Investigator(s) at Institute(s)/Unit(s) under
CCRH. (Annexure A).
STUDY DESIGN: The design / protocol of the study will be formulated at central level in
consultation with experts, monitoring officers, investigators at the periphery (study sites). The
study design and conduct may follow the standard research guidelines.
STATUTORY, ETHICAL and RESEARCH GUIDELINES: Protocols will be approved by the
headquarters through Central Ethic Committee or Institutional Animal Ethics Committee,
Special Committee/ SAC, SFC (wherever required).
RELEASE OF FUNDS: No separate funds will be allocated for each centre but will be
funded centrally.
EQUIPMENTS AND MAN POWER: Equipments required for the studies will be decided
according to the protocol and will be provided to the study sites as per need of the project.
Wherever there is need of outsourcing of Laboratory investigations, the same will be
considered after due approval process of the competent authority. Additional manpower, if
required in terms of contractual employer (Technical and Non-Technical) as per need of the
project(s) shall be appointed after due approval of the competent authority.
MONITORING: The projects shall be monitored. Monitoring shall be conducted for ongoing
projects from time to time in the following ways i.e. on regular basis by the CCRH
headquarters. RB (Review Board)/EC may visit onsite or engaged experts for data
monitoring/protocol compliance. Review Board will be authorized to call investigator(s) from
periphery for presentation of the study. Recommendations of the Review Board/EC for
satisfactory/ unsatisfactory program of the study shall be placed before the SAC for the
decision.
PROGRESS REPORT:
Reports from study site will be reviewed at headquarters for final compilation. Chief
Coordinator shall ensure monthly acquisition of data in the enrollment cases/follow ups
and to be compiled for record purposes at the headquarters. Chief Coordinator may
also ensure that there should not be any change in the research team at the
headquarters/study site for smooth progress of the project(s). If any eventuality where
a study personal is to be transferred the Chief Coordinator has to ensure that all
related documents should be handed over to next person taking the charge.
PREMATURE TERMINATION: SAC will be having full authority for discontinuation on the
recommendation of RB/EC.
PUBLICATION: Nodal Officer(s) for writing manuscript of the study for publication in case of
multicenter studies shall be decided by the Chief Coordinator. Manuscript of the study for
publication in case of multicenter studies shall be sent to publication in Peer Reviewed

CCRH Research Policy
Journal through Chief Coordinator. Name of the Peer Reviewed Journal where it is to be
submitted shall be decided by Chief Coordinator.
INTELLECTUAL PROPERTY RIGHTS AND PATENTS (which includes methods,
equipments and products):
The patent (which includes methods, equipments and products) will be jointly applied
by the Council, and the Principal Investigator of the project. The Council will make joint
efforts to commercialize the product as applicable.
The investigator or the staff employed on the research project shall not obtain patents
cited above for any invention/discovery made by them without prior approval of the
Director General, CCRH (on the basis of the recommendation of the PEMC/ Director
General).
Only permanent employees (scientists) of CCRH will be the part of IPR related issues.
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CCRH Research Policy
GUIDELINES FOR SCHEME B
14
Annexure B
Intra Mural Research with funding to individual scientist, who are permanent technical
employees (Research Officer and above) of the Council and monitoring will be done by
Headquarters .
1. ELIGIBILITY:
1.1 Who are eligible?
Scientists who are permanent employees of CCRH are eligible.
1.2 Infrastructure
The Institutes/Units under CCRH which have been sanctioned a project under the
schemes of CCRH should have adequate infrastructure to pursue the research projects
and in case, such facilities are not available the same requirement must be reflected in
the project proposal to develop the required facilities by upgrading the laboratories of
the Institute or otherwise may be outsourced through accredited laboratories with
justification.
1.3 Investigators & Tenure of the Project
1.3.1. There will be one Principal Investigator (PI) and maximum two Co-I‟s for each project.
1.3.2. While submitting an application for a research project, the PIs should give the details
of all the research projects (completed, on-going under CCRH research Scheme and
under any other scheme of Government of India or any other organization).
1.3.3. Change of PI
PIs are encouraged to have a Co-Investigator (Co-I) in the project. However, in
one study there should not be more than two Co-Is.
If for any reason the PI leaves the project, an eligible Co-investigator could be
considered as the PI subject to recommendation of the PI, the Head of the
Institution, and the approval of the Council. Such a request should be sent well in
advance.
The Principal Investigator will have to inform the Council, of any changes, and in
consultation with the Council take steps to ensure successful completion of the
project.
1.3.4 The tenure of a project will be maximum for a period of three years. Extension of the
project may be given subject to approval Project evaluation and monitoring committee
(PEMC).
2. MODE OF APPLICATION
2.1 The details of the Research policy and schemes shall be available from Website of the
CCRH: www.ccrhindia.org.
2.2 SUBMISSION OF PROPOSAL: The Principal Investigator shall submit the concept
proposal in prescribed format (Annexure 1) to the Director General, CCRH through Head
of the Institute / Unit. On acceptance of concept proposal by PEMC, the detailed proposal
will be called for consideration.
(Note –It is mandatory to submit the application in 10 hard copies and one soft copy in CD)
3. PROJECT EVALUATION & MONITORING COMMITTEE (PEMC): The proposals under
scheme B will be evaluated on their merit. The Research proposals will be scrutinized
and evaluated and monitored by the Committee or their nominees comprising of the
following members:

CCRH Research Policy
1. Director General, CCRH - Chairman
2. 2 Subject experts (including one Homoeopath) - Member
3. Bio-statistician - Member
4. One representative from the Deptt. of AYUSH - Member
5. Deputy Director (Homoeopathy),CCRH/nominated by Director General
- Member secretary
The chairman can invite any person(s) as special invitee(s) besides above as per need of
the study.
3.1 Terms of reference of PEMC: The PEMC after the evaluation/ scrutiny of the Research
Proposals may
Recommend and approve suitable projects
Call for the Principal Investigator/Co-Investigator for discussion
Invite comments from the expert(s) in the concerned field.
Inform the applicants to modify their proposals (as per their observations)
Reject the proposals, if not found suitable.
4. FINANCIAL SUPPORT:
4.1 The project cost shall be met from sanctioned budget of CCRH Hqrs. from Research
activities head. (Maximum of Rs. 40.00 lakhs per project spread over a period maximum
of 3 years). The salary component of the temporary manpower engaged under these
projects should not exceed 30% of the total budget.
4.2 Funds for the Principle Investigators applying for the grant will be given only for the
essentially required staff, equipment, books and contingent items. The Laboratory
investigations for the project will be carried out at the institutes itself. In case some
investigations not possible to carry out at the institute may be outsourced after following
codal formalities.
4.3 Assets: All the assets created through the projects under the schemes shall devolve
to CCRH.
4.4: Release of funds and Operation of Accounts:
There will be no additional salary provided to the permanent employees of CCRH as
well as other collaborating organizations. The funds will be released to the Principle
Investigator(s) through the in-charge/head of institute in the following manner:
i. The council shall release the funds for the project(s) installment wise as
approved by the PEMC/ SAC/SFC.
ii. The funds will be released to the individual scientist/ research officer through
the head of the research institute/unit for such funds released a separate
account at the Instt./Unit level will be maintained which shall be subject to
internal audit for release of subsequent installments.
iii. 5% of the sanctioned amount will be released after submission of final
progress report, / research article and expenditure duly audited by Internal
Auditor.
iv. Operation of Accounts: The funds will be provided to the institutes as a part
of Institute‟s budget, in the mechanism followed by the Council normally and
the Head/ In-charge will provide the funds as per the requirement from the PI
from time to time. In the matter of purchase of non- recurring items, codal
formalities will be observed.
v. The operation and utilization of accounts of the projects will be subject to
internal audit.
15

CCRH Research Policy
5. PERSONNEL/STAFF:
S.
No
5.1 Engagement of Consultants/ Project Personnel
Appropriate manpower / experts in concerned disciplines will be engaged as per
need and nature of the project as per requirement.
5.2 Supporting Scientific Staff (Consultants): Engagement of minimum number of
supporting manpower (Consultants), having expertise in the concerned research
study and clearly identified role in the proposed study, may be proposed with fixed
monthly remuneration which, if approved, may be paid from the head „Salary‟ of the
project proposal.
5.3 Para-Medical and Non-Scientific Manpower: The Para- Medical, Non-Scientific
manpower and other supporting manpower will be considered on the basis of the
requirement relevant to the study and would be time bound on consolidated
emoluments. Permissible manpower will depend upon the proposal.
5.4 General terms and conditions for engaging temporary project manpower (above
mentioned scientific, paramedical and non scientific staff):
Selection Committee: A selection committee should be constituted at institute
level consisting of the members comprising of:
1. Principle Investigator
2. Head of the Institute
3. Expert from concerned subject and
4. Nominee(s) of Director General CCRH.
The letter of engagement may be issued in the name of In-charge/ head of the
institute/organization for the projects under scheme.
Appointment will be of temporary and contractual nature for a maximum period of
the duration of the study. The appointment of all categories of project personnel
would be made initially for maximum one year and extended by specific orders
for such period as may be necessary, but not exceeding one year at a time.
The personnel will have no claim for regular/permanent appointment under the
Council. Their engagement will be co-terminus with the project.
5.5. Recruitment criteria and emoluments for contractual technical staff*
Staff Qualifications and Experience
1. Research Associate
(RA): (One or Two)
2. Senior Research
Fellow (SRF): (One or
Two)
Ph.D. in the concerned subject
OR
Post-Graduation in Homoeopathy/
Degree qualification in the Homoeopathic System/
Allopathy; M.Pharma/ M.E./ M.Tech./ MVSc. with
minimum 3 years research experience i.e. having
worked for any research project funded by the
Department of AYUSH, ICMR, CSIR, DST or
equivalent organization.
Degree qualification in the related Homoeopathy
system/ Allopathy/ Pharmacy/ Pharmacology/
Engineering/ Biotechnology/ Agriculture/ Veterinary
Science/Bio-Statistics/Physiotherapy/ Occupational
therapy, etc.
Preference will be given to those who possess
higher qualification or who have previous research
experience i.e. having worked for any research
project funded by the Department of AYUSH, ICMR,
CSIR, DST or equivalent organization.
16
Amount of assistance
as per revised rates of
ICMR*
23000 per month +
HRA
MEDICAL
1 st , 2 nd and 3 rd Year –
Rs.20,000/- per
month + HRA
NON-MEDICAL
1 st and2 nd Year –
Rs.18,000/- per
month + HRA
3rd year –
Rs.20,000/- per
month + HRA

CCRH Research Policy
3. Junior Research
Fellow (JRF): (One or
Two)
Bachelor Degree in the required discipline
17
1 st and 2 nd Year –
Rs.16,000/- per
month + HRA
3rd year –
Rs.18,000/- per
month + HRA
*The emoluments will be subject change as per the ICMR guidelines and approval of competent authority of the Council
6. SUBMISSION OF REPORTS:
The following reports on the progress of work done under the research scheme will be
submitted to the Council:
6.1. Progress Report
Half yearly/Quarterly (as per the need) progress report on physical achievements
is to be submitted to the council regularly as per reporting proforma (Annexure
B1). Besides these, progress reports for the first and second year is to be
submitted within one month of completion of reporting year in the prescribed
format.
The project will not be renewed for the next financial year unless the Council
receives the progress report in time.
The PI may be asked to present the progress at the meeting of the PEMC, if
considered necessary.
The suggestion and views of the PEMC and mid-course correction, if any, would
be conveyed to the PI, for effective conduct of the project. This would be binding
on the PI/grantee institution.
Ten hard copies and one soft copy (in CD) of the yearly progress report would be
submitted.
6.2 Final Project Completion Report
At the completion of the project, the final report ((Annexure B2) should be sent in the
prescribed format for all the schemes. The report should be submitted within three
months from the date of completion of the project. Ten hard copies and soft copy (in
CD) of the Final project Completion report would be submitted.
7. MONITORING:
The Director General/ chairman, PEMC would ensure periodic review and monitoring of
the projects on going under the Schemes. The experts, selected by the Director General
will monitor the technical and financial execution of the project. For the purpose of
monitoring the Director General and/or the experts selected by the Director General may:
Review the progress reports received from time to time by the Council from the
PI/investigator
Invite the PI/investigator to make a presentation before the experts
Invite the PI/investigator to bring the relevant papers and documents related to the
project
Make an on-site visit, where the PI/investigator would ensure their access to all the
relevant documents related to the Project
To involve experts of the concerned fields to streamline the monitoring process by
the Councils; onsite visits will also be arranged to cross check the quality of the work.
It is mandatory on the part of PI/investigator to provide all information and records to the
monitoring person(s), auditors etc.
The expenditure for monitoring of the project would be provided by the respective
Research Councils from their budget.

CCRH Research Policy
8. OUTCOME OF THE PROJECT:
The final technical and financial reports of each completed study will be examined by the
PEMC, who will convey their views to the Director General, CCRH for consideration. PEMC
will also give their comments on the results of the studies.
9. PRE-MATURE TERMINATION OF PROJECT:
The termination of the projects on appropriate technical grounds may be done after critical
evaluation by the council/ PEMC set up by the council. During the course of the study, the
PEMC may recommend to the Director General, CCRH for termination of the study, if it is
convinced that the study is not being done in accordance with the research proposal
approved by the PEMC/Director General, CCRH, or in view of any other
Technical/Financial/Ethical irregularities. In such case, the Director General, CCRH would
have the authority to revoke the funds given to Principle Investigators, partially or fully, as
recommended by the PEMC. The equipments and instruments procured through the projects
will be property of the Council. Interim analysis can be conducted on the recommendation of
either PI or PEMC and if the results as per the objectives of the study showed required
statistical significance then the study can be concluded pre-maturely with a credit to the
PI/Investigator.
10. INTELLECTUAL PROPERTY RIGHTS AND PATENTS (which includes methods,
equipments and products):
10.1 The patent (which includes methods, equipments and products) will be jointly applied by
the Council, and the Principal Investigator of the project. The Council will make joint
efforts to commercialize the product as applicable.
10.2 The investigator or the staff employed on the research project shall not obtain patents
cited above for any invention/discovery made by them without prior approval of the
Director General, CCRH (on the basis of the recommendation of the PEMC / Director
General).
10.3 Only permanent employees (scientists) of CCRH will be the part of IPR related issues.
11. PUBLICATION:
Outcome of the project shall be published in the peer reviewed journals etc. It is mandatory
to publish the findings after completing the project subject to IPR issues. The PI /investigator
will submit the final consolidated report to the Council, after the completion of the project. A
manuscript of the study would also be sent to the Council by the PI for publication in the peer
reviewed Journals. Publications of the study in part or full are not permissible before
acceptance of the final report by the Director General, CCRH on the recommendation of the
PEMC.
18

CCRH Research Policy
Intramural Research Policy
Scheme C – Collaborative Research
19
Annexure-C
Central Council for Research in Homoeopathy
MINISTRY OF HEALTH and FAMILY WELFARE
DEPARTMENT OF AYURVEDA, YOGA and NATUROPATHY, UNANI, SIDDHA, SOWA
RIGPA AND HOMOEOPATHY (AYUSH)
GOVERNMENT OF INDIA

CCRH Research Policy
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
SCHEME FOR INTRA MURAL RESEARCH (IMR) through Collaboration
1. BACKGROUND:
In the current global scenario international collaborative efforts are recognised as one of
the factors in successful research because of the complimentarity of technology transfer,
capacity building and access to diseased populations. Currently CCRH is collaborating
internationally with UCLA, WHO, and ISCHI. Linkages with international developmental
partners and WHO and other UN agencies shall be further developed and strengthened to
ensure that India plays a legitimate role as an emerging economy. Such proposals will be
considered under Schemes C & D of CCRH.
Homoeopathy, since its inception being criticized for it‟s medicine (ultra-diluted), which
don‟t contain the source material and for lack of explanation for mode of action of its
medicines. Though a few theoretical models have been proposed in the past to describe the
mode/route of action of these medicines, but a little research has been conducted to
substantiate this. For example most recently Wijk VR et al tried to establish relation between
similia principles with post-conditioning hormesis 1 .
Though a basic research has been done to understand homoeopathy, but these are
in early stages of explaining homoeopathy. However, following are limitations-
i. Too little discussion as to whether observed phenomena match clinical
observation.
ii. Observed effects are small.
iii. Reproducibility is problematic.
iv. Quality of research is sometimes questionable.
Council has been trying to upgrade its laboratories and take up skilled manpower to conduct
such type of research, though all type of research is not feasible by one Institute. However at
present state of infrastructure and expertise Council has to collaborate with other Institute of
repute to conduct such type of studies i.e. collaborative research.
Collaborative research may be defined as the strategic research program where the parties
involved and work together, especially in a joint intellectual effort in order to accomplish a
shared vision and impact the benchmarks with the sharing of assimilated knowledge, higher
productivity motive, common goal-oriented attitude, high leadership qualities, high level of
trust on a time & cost reduction theme.
To promote collaborative research Council has introduced Intra Mural Research Scheme
(Scheme-C), under which Institutes/Units under the Council can apply to collaborate with
other Institute of repute in various field to undertake projects in research areas identified by
the Council.
The area of study will be identified by the Council.
The Council will identify the institute/scientist, where to conduct study and will
approach them.
The Council will identify the scientist (s) of the Council to be involved in the
study.
Otherwise interested individual scientist of CCRH , who can arrange such
collaboration with reputed institute in the identified area of study.
Protocol of the study will be prepared by both the team in joint venture.
The Council will be the regulatory body.
1 Wijk Roeland Van, Wiegant Fred A.C. Postconditioning hormesis and the similia principle. Frontiers in Bioscience
E3, 1128-1138, June 1, 2011.
20

CCRH Research Policy
2. AIMS AND OBJECTS:
2.1. To develop joint research venture among the CCRH Institutes and other
Organizations/Institutes.
2.2. To explore & explain scientificity behind various concepts, theories of homoeopathy.
2.3. To generate data on safety, standardization and quality control for homoeopathic
products and practices;
2.4. To develop evidence based support on the efficacy of homoeopathic drugs and
therapies;
2.5. To generate data on heavy metals, pesticide residues, microbial load, safety/toxicity etc.
in the raw drugs and Homoeopathic mother tincture.
2.6. Seeks new knowledge and promote research in new area of knowledge, where no
venture has been made.
3. PRIORITY AREAS OF RESEARCH:
The Council will determine priority areas of research from time to time and encourage
collaborative studies in these identified areas.
A. Evidence based research in the areas where other systems of treatment have a
limited role like;
Auto-immune diseases,
Lifestyle disorders in children like obesity, juvenile diabetes mellitus and
behavioral, learning disorders.
Viral infections
Diseases where side effects of medicines overweigh the relief like cancer
chemotherapy, anti tuberculosis drugs, anti retroviral drugs, epileptic drugs
etc.
Diseases originating due to radiation effects.
B. Scientific research on fundamental and basic principles of Homoeopathy.
i. To elicit the mechanism of action of small dose of Homoeopathic medicine
ii. To identify the nature of Homoeopathic medicines in ultra dilution in
potentised form
iii. To explore and establish the pathway of action of Homoeopathic medicine
iv. To understand the science behind action of Homoeopathic medicine
C. Agro-Homoeopathic studies
D. Veterinary Homoeopathic studies
E. Drug Development and standardization
i. Standardization and quality assurance
ii. Pharmaceutical Research and Development
iii. Pharmacognosy (in-vitro and in-vivo methods)
iv. Biomarker based mechanism of action
4. ELIGIBILITY:
Scientists of CCRH who are permanent employees.
Research organization of repute to which CCRH wants to Collaborate.
4.1 Who are eligible?
Reputed Institutes/Organizations (both Government and Private) Laboratories, Drug
Manufacturers, etc. having adequate infrastructure in terms of equipment and
manpower to conduct high quality research.
Universities/Educational Institutions
Eminent scholars and Scientist, (who are full time regular employees of the institute),
reputed institution /organization having good research background and contribution
21

CCRH Research Policy
to the medical research can apply, as stated above. However, preference will be
given to institutes directly as they have better infrastructure.
The Institute/units of the Councils may apply for Intra Mural Research funding
for collaboration with other reputed Institute.
5. Infrastructure required
The institutions/investigators with whom, collaboration is to be made should have
adequate infrastructure to pursue the research project. In case of clinical research,
clinical facilities including OPD and IPD (wherever required) and laboratory facilities for
bio-chemical, pathological, radiological and electro-physiological investigations
supported with necessary equipment relevant to the project should be available. In case
of studies for safety and standardization, adequate laboratory facilities and animal
house should be in place.
6 Investigators:
6.1 There will be two Principal Investigators (PI) and one from the CCRH and other from
collaborating institute. One or maximum two Co-Investigator(s) [Co-I] for each
project. Either of the PI should be from the concerned field along with sufficient research
background. In exceptional cases, where there is no subject (Homoeopathy) expert in
the proposal submitted, the PEC would decide if the study requires a subject expert to
be engaged as a consultant.
6.2 Under normal conditions, at a given point in time, a PI of the Council should have one
funded project. Fresh research proposals can be considered only when the on-going
research proposal are about to conclude (includes publication).
7. MODE OF APPLICATION
7.1 The details of the Research policy and schemes shall be available from Website of the
CCRH: www.ccrhindia.org.
7.2 SUBMISSION OF PROPOSAL: The Principal Investigator shall submit the concept
proposal in prescribed format (Annexure 1) to the Director General, CCRH through Head
of the Institute / Unit. On acceptance of concept proposal by PEMC, the detailed proposal
will be called for consideration.
(Note –It is mandatory to submit the application in 10 hard copies and one soft copy in CD)
8. Project Evaluation cum Monitoring committee
The Research proposals will be scrutinized/ evaluated by the Project Monitoring cum
Evaluation Committee (PMEC) constituted by the Council. PMEC would comprise of:
1. Director General of CCRH Chairperson
2. Three experts having published research work out of which
one will be from homoeopathy Members
3. One expert statistician Member
4. Dy. Director(H) or nominated by the Director General Member Secretary
Terms of reference for PEMC:
Call for the Principal Investigator/Co-Investigator to explain their proposals in person
May invite comments from the expert(s) in the concerned field.
Reject the proposals, if not found suitable
Inform the applicants to modify their proposals (as per their observations)
Recommend the proposal to Scientific Advisory Committee for approval.
9. Memorandum of Understanding:
CCRH and the collaborative institute shall sign a MoU on mutually agreed terms and
conditions
10. FINANCIAL SUPPORT:
22

CCRH Research Policy
10.1 The Council will provide financial support for staff, equipment and contingencies
(recurring and non-recurring) for the project for a period of maximum 3 years after approval
from Standing Finance committee.
10.2 The institutions/ individuals applying for the grant 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 and
not for capital work and purchase of lands.
10.3 Institutional support: 5% of the total cost of the project (excluding the cost of
equipment) would be provided to the educational institutions and 3% of the cost of the
project (excluding cost of equipment) would be provided to the organizations, other than
educational institutions, engaged in research under Collaborative scheme, as
Institutional Support after the successful completion of the project to the satisfaction of
the PEMC/SAC.
11. EXPENDITURE:
All recurring and non-recurring items required for work of the project should be
purchased in accordance with the procedures and guidelines of the State Government
(for State Government, Private and Non-Governmental Organizations/Institutes) or those
of the Central Government (in case of Central Government Organizations). For
permanent and semi-permanent assets acquired solely or mainly out of the grant, the
Institute shall maintain a separate audited record in the form of register such as cash
book, asset register, paid bills, bank statements and bank accounts, etc. The term
"assets" means moveable property where the value exceeds Rs.1000/-. Separate assets
registers for items costing more than Rs. 1000/- and less than Rs.20,000/- and more
than Rs.20,000/- may be maintained.
11.1 Non-Recurring Expenditure: Essential scientific equipment including computer and
software, if needed, may be permitted as non-recurring expenditure. This does not
include purchase of land or any capital work. However, the quantum of such
expenditure will not be more than 25% of the total project cost. The equipment will
become the property of the host institution(s) after successful completion of the project.
Books purchased out of the contingencies may be retained by the Principal
Investigator after successful completion of the project. In case of premature termination
due to unsatisfactory progress as per recommendations of PEMC, the equipment will
become property of the Council.
11.2 Recurring Expenditure: The expenditure of recurring nature such as medicines,
chemicals, glassware, cost of investigations, animals, stationeries, postage, printing,
photocopying, etc. may be allowed to be purchased as a part of the recurring
contingencies.
11.3 Guidelines for incurring expenditure:
This is meant for recurring as well as non-recurring expenditure. The grant can be
utilized for purposes like, but not limited to:
1. Acquisition of books, in case these are not available in the library
2. Chemicals/Consumable items required solely for research project
3. Charges for specialized investigations for which facilities do not exist in the grantee
institute
4. Data entry charges
5. Printing of questionnaires, case report forms, consent forms, etc. for the research
project
6. Computer utilities, charges for analysis of data
7. Typing and printing of research reports
8. Communication charges
23

CCRH Research Policy
The grant cannot be used for purchase of furniture items, office equipments such as
telephone, fax machine, photocopiers, etc.
11.4 Utilization of Travel grant: The funds earmarked under TA/DA can be utilized, for
travel within the country, by the PI, Co-Investigator or Research staff working on the scheme
for the following purposes:
Attending seminars/symposia/conferences within the country provided the PI
himself/herself or the project staff is presenting a research paper (Related to the
subject of the study), which has been accepted. Copy of the acceptance letter
should be sent to the Research Council(s).
Taking up field work/travel connected with the research work
Visiting the Research Council(s) for meetings related to the project
Attending a training course/seminar/conference/workshop related to the project
The travel grant cannot be used for foreign travel.
In utilization of Travel Grant, TA/DA should be as per the rules and guidelines for entitlement
as prescribed by the State Government (for State Government, Private and Non-
Governmental Organizations/Institutes) or those of the Central Government (in case of
Central Government Organizations).
12. PERSONNEL/STAFF:
12.1 Scientific Staff
S.
No
Staff Qualifications and Experience
1. Research Associate
(RA): (One or Two)
2. Senior Research
Fellow (SRF): (One or
Two)
3. Junior Research
Fellow (JRF): (One or
Two)
Ph.D. in the concerned subject
OR
Post-Graduation in Homoeopathy/
Degree qualification in the Homoeopathic System/
Allopathy; M.Pharma/ M.E./ M.Tech./ MVSc. with
minimum 3 years research experience i.e. having
worked for any research project funded by the
Department of AYUSH, ICMR, CSIR, DST or
equivalent organization.
Degree qualification in the related Homoeopathy
system/ Allopathy/ Pharmacy/ Pharmacology/
Engineering/ Biotechnology/ Agriculture/ Veterinary
Science/Bio-Statistics/Physiotherapy/ Occupational
therapy, etc.
Preference will be given to those who possess
higher qualification or who have previous research
experience i.e. having worked for any research
project funded by the Department of AYUSH, ICMR,
CSIR, DST or equivalent organization.
Bachelor Degree in the required discipline
24
Amount of assistance
as per revised rates of
ICMR*
23000 per month +
HRA
MEDICAL
1 st , 2 nd and 3 rd Year –
Rs.20,000/- per
month + HRA
NON-MEDICAL
1 st and2 nd Year –
Rs.18,000/- per
month + HRA
3rd year –
Rs.20,000/- per
month + HRA
1 st and 2 nd Year –
Rs.16,000/- per
month + HRA
3rd year –
Rs.18,000/- per
month + HRA
*The emoluments will be subject change as per the ICMR guidelines and approval of competent authority of the Council
Note: 1. The qualifications must be recognized by the concerned regulatory
Council’s /Universities/Faculties/Boards.

CCRH Research Policy
2. Number of RA/SRF/JRF should be claimed as per actual need of the project
and the decision of the PMEC/SFC is final in this respect.
3. The amount of assistance may be revised by the Council to keep at par with
those at Indian Council of Medical Research (ICMR).
12.2 Supporting Scientific Staff (Consultants): Engagement of minimum number of
supporting staff (Consultants), having expertise in the concerned research study and clearly
identified role in the proposed study, may be proposed with fixed monthly remuneration
which, if approved, may be paid from the head „Salary‟. In such cases less number of
RA/SRF/JRF may be proposed.
12.3 Non-Scientific Staff: The other supporting staff will be considered on the basis of
the requirement relevant to the study and would be time bound on consolidated emoluments.
Permissible manpower will depend upon the proposal.
12.4 Appropriate Honorarium of Rs.20,000/- to Rs.60,000/- (for the total duration of
project) to the Principal Investigator may be provided depending on the nature/duration of
the project. Appropriate fee of Rs. 10,000/- to 30,000/- (for the total duration of project) may
be provided to the Co-I(s) depending on the nature/duration of the project. In case of 2 Co-
Is, this amount would be shared by them. This fee would be released only after successful
completion of the project and acceptance of the final report of the study by the PMEC/SFC.
12.5 General terms and conditions of man-power engagement:
The appointment of all categories of staff would be made initially for one year and
extended by specific orders for such period as may be necessary, but not exceeding
one year at a time.
Appointment will be of temporary and contractual nature for a maximum period of the
duration of the study.
The personnel will have no claim for regular/permanent appointment under the
Research Councils / Department of AYUSH or the Grantee Institute on completion of
the period of appointment.
Dearness Allowance (DA) and City Compensatory Allowance (CCA) are not
admissible to any category of staff employed under EMR projects.
HRA will be allowed to all categories of JRFs/SRFs and Research Associates as per
the rules of the Institutions where they are working. For this purpose, the fellowship
amounts for JRFs/SRFs and Research Associates will be taken as basic pay.
Leave, salary and other service benefits: RAs, JRFs, SRFs will continue to be eligible
for the Casual Leave irrespective of category and medical leave as applicable in the
host institution. However, Maternity Leave will be given to female staff.
Bonus, L.T.C and Retirement benefits are not admissible to RA/SRF/JRF/nonscientific
staff employed for the study.
13. RELEASE OF FUNDS:
The grants will be released in the name of the Head of the Institution as yearly installments.
The first installment is released along with the sanction letter, which would include the entire
grant for purchase of equipment and books, and recurring grant for first year. The 2 nd /3 rd
installment(s) would be released subject to the satisfactory progress of the study and timely
receipt of the following documents in the prescribed proforma:-
Annual Progress Report
Statement of expenditure and Utilization Certificate) in original, duly signed by the PI,
Head of the Institute and the Auditor; and
Mid-term appraisal by monitoring committee or expert(s) after presentation by the
Principal Investigator/Co-I.
10% of the proposed expenditure of the study will be held back till the receipt and
acceptance of Concluding Report & the manuscript.
25

CCRH Research Policy
This 10% will be released in 2 parts i.e. 5% after acceptance of Concluding report &
remaining 5% after publication of the article and receipt of the UC along with audited
statement of accounts.
14. PUBLICATION
Publications, if any, in respect of the activity under the MoU shall be decided mutually
depending upon the relative contribution made by the personnel. Any initiation made for
publication (paper, reports etc.) should be informed to other party and consent in writing
have to be obtained. In all publications (papers, reports etc.) it will be duly acknowledged
that the work has been carried out by collaborating institute and CCRH under the MoU.
15. DURATION
The MoU shall be effective from the date of the receipt of the 1 st annual grant and shall
remain valid for a period of the project from the date of signing of the MoU or receipt of
first grant whichever is later. This will extended on mutual consent between two
organizations and as per requirements of the project.
16. MONITORING
The progress of implementation of the PROJECT and proper utilization of grant shall be
reviewed by the CCRH and by the Monitoring Committee set up by CCRH. The parties
will use their best efforts to settle all matters in dispute amicably. All disputes and
differences of any kind related to this MoU shall be jointly settled between collaborating
institute and Director General, CCRH.
17. TERMINATION
Project may be terminated by either party by giving three months notice in writing to the
other party. Either of the parties shall honour within a mutually agreed period, the
outstanding commitments, if any, as on the date of termination. The parties shall agree
that the termination of the Memorandum means the termination of the PROJECT also.
In case of premature termination of the project the equipments utilized/ unspent
purchases under the project will become the property of funding agency.
18. CONFLICT OF INTEREST
In order to maintain the objectivity in the conduct and reporting of research, it is
imperative that the investigators should not have any interests that undermine
scientific integrity while recording and reporting their data. Any research or other links
of the investigators with industry are discouraged as such a link would compromise or
likely to compromise unbiased reporting of research data. In addition, such a financial
conflict of interest could lead to loss of public faith on the credibility of data being
reported. All investigators, desirous of the Collaborating Scheme support should
declare financial conflict of interest, if any, before submitting the project for support.
They should also ensure that during the conduct of the project, they would also
observe the same code of conduct. If the Research Council/Department of AYUSH
comes to know of any unethical conduct on the part of Investigator(s) including
improper/incomplete declaration, the project is liable to be terminated, immediately
along with action taken for recovery of funds.
19. IN THE EVENT OF DEFAULT:
i) In the event, the grantee Institution fails to perform its activities, duties,
obligations, acts and deeds as per the scheme and the Annexures appended
thereto, the terms of this agreement, instructions, orders issued from time to time,
will amount to default and in such circumstances, the Council can recall the
entire funds provided and stop further release of installments.
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CCRH Research Policy
ii) In such case of default, Grantee Institutions shall refund the amount disbursed to
them within 15 days of receipt of such intimation from the Council. Interest @
12% shall be charged if the amount is not returned within this stipulated time.
iii) All the Officers bearers, Principal Investigators, Co-Investigators, President,
Chairperson, Secretary, or any other person or person(s) functioning to the grantin-aid
Institution shall be generally and severally responsible and liable to refund
the amount with the interest and can also be prosecuted both under the Civil and
Criminal Law for breach or default as stated above.
iv) Jurisdiction: All disputes or differences between the Council and the grantee
Institution shall be decided by referring to arbitration in which the Director
General, CCRH shall be the arbitrator, whose decision shall be final and binding.
v) PIs/Institutions not complying with provisions of scheme will be debarred from
further grants.
vi) The Courts at Delhi shall have the only and exclusive jurisdiction for all matters
connected to such disputes / differences.
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CCRH Research Policy
INTRAMURAL RESEARCH POLICY
Scheme - D
28
Annexure-D
Central Council for Research in Homoeopathy
MINISTRY OF HEALTH and FAMILY WELFARE
DEPARTMENT OF AYURVEDA, YOGA and NATUROPATHY, UNANI, SIDDHA, SOWA
RIGPA AND HOMOEOPATHY (AYUSH)
GOVERNMENT OF INDIA

CCRH Research Policy
1. BACKGROUND:
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
SCHEME - D
Drug development is a cumbersome and time consuming process. Though in homoeopathy
all the parameters for drug development process are not taken up citing that drug proving
are done on healthy human beings and medicinal content are minute even not traceable.
And for some drugs (in crude state) certain information are available. However, we have no
information how the medicine behaves physiologically in high homoeopathic potencies (ultradiluted).
Specifically for the medicines prepared from microbiological agents, disease
products, toxic substances etc.
Area-D
The area of study will be identified by the Council.
The Council will identify the institute/scientist, where to conduct study.
Protocol of the study will be prepared the scientist (s) of the collaborating
Institute and submitted to the Council for approval.
Council will draw a time line for the study.
The Council will provide funding and be the regulatory body.
2. AIMS AND OBJECTS:
2.1 To do various drug developmental studies like pharmacological, Physico-chemical,
toxicological of source material and certain potencies;
2.2 To generate data on safety, standardization and quality control for homoeopathic
products;
2.3 To generate data on heavy metals, pesticide residues, microbial load, safety/toxicity etc.
in the raw drugs and Homoeopathic mother tincture.
2.4 Technological development of manufacturing process etc.
2.5 Seeks new knowledge and promote research in new area of knowledge, where no
venture has been made.
3. METHOD:
The Council will seek the expression of interest of various institutes through the
advertisement in public media, which will specify the nature of work. The work will be time
bound and monitored by the Council.
5. ELIGIBILITY:
Research organization of repute.
5.1 Who are eligible
Reputed Institutes/Organizations (both Government and Private) Laboratories, Drug
Manufacturers, etc. having adequate infrastructure in terms of equipment and
manpower to conduct high quality research.
Eminent scholars and Scientist, (who are full time regular employees of the institute),
reputed institution /organization having good research background and contribution
29

CCRH Research Policy
to the medical research can apply, as stated above. However, preference will be
given to institutes directly as they have better infrastructure.
5.3 Infrastructure required
The institutions/investigators with whom, collaboration is to be made should have
adequate infrastructure to pursue the research project. In case of laboratory facilities
for bio-chemical, pathological, radiological and electro-physiological investigations
supported with necessary equipment relevant to the project should be available. In
case of studies for safety and standardization, adequate laboratory facilities and
animal house should be in place.
6. MODE OF APPLICATION
6.1 The details of the Research policy and schemes shall be available from Website of the
CCRH: www.ccrhindia.org.
6.2 SUBMISSION OF PROPOSAL: The Principal Investigator shall submit the concept
proposal in prescribed format (Annexure 1) to the Director General, CCRH through Head
of the Institute / Unit. On acceptance of concept proposal by PEMC, the detailed proposal
will be called for consideration.
(Note –It is mandatory to submit the application in 10 hard copies and one soft copy in CD)
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CCRH Research Policy
31
Annexure1
CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
CONCEPT PROPOSAL FORMAT
(Complete in English, do not exceed one page, Times Roman font, 11 point)
I. CONCEPT IDENTIFIERS:
►1.1 Date:
►1.2 Title:
►1.3 Acronym or short title (if applicable):
►1.4 Type of study:
►1.5 Length of study:
►1.6 Estimated total cost: Rs. (Rupee)
►1.7 CCRH Project Number (CCRH USE ONLY):
II. CONTACT INFORMATION:
►2.1 Principal Investigator name:
►2.2 Principal Investigator title/position:
►2.3 Institution:
►2.4 Mailing address:
►2.5 City:
State/Province:
Zip/Postal Code:
Country:
►2.6 Telephone: Fax: E-Mail:
►2.7 Co-Investigator names/Institutions:
III. NON-TECHNICAL SUMMARY (one paragraph):
IV. OBJECTIVES AND SIGNIFICANCE:
Rationale: (What does this study hope to achieve, why is it important? (One paragraph):
V. BUDGET CONSIDERATIONS:
►5.1 Direct costs: Rs. ; Indirect costs/overhead: Rs.

CCRH Research Policy
Annexure1
PROTOCOL SUMMARY
(Complete in English, do not exceed 2 pages, Times Roman font, 11 point)
VI. BACKGROUND (pertinent to this study):
VII. APPROACH/METHODS (in structured abstract format with the following elements):
►7.1 Specific Aims/Objectives/Hypotheses:
►7.2 Disease/Condition/Model:
►7.3 Setting:
►7.4 Population/Sample:
►7.5 Study Design:
►7.6 Inclusion/Exclusion Criteria or Sample Conditions:
►7.7 Intervention and Control Group(s):
►7.8 Endpoints and Measures (primary/secondary/intermediary):
VIII. ETHICS AND RESEARCH GOVERNANCE
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CCRH Research Policy
Annexure1
PRINCIPAL INVESTIGATOR BIOGRAPHICAL SKETCH
(Complete in English, do not exceed 3 pages, Times Roman font, 11 point)
NAME POSITION TITLE
EDUCATION/TRAINING (Begin with undergraduate degree)
INSTITUTION AND LOCATION
DEGREE
A. Positions and Employment relevant to this proposal:
33
YEAR(s) FIELD OF STUDY
B. Other Experience and Professional Memberships relevant to this proposal:
C. Your relevant peer-reviewed publications (in chronological order starting with the
most recent, maximum 12):
D. Research Support relevant to this project. (Past or current):

CCRH Research Policy
1. Project title
2. PI (name and address)
FORMAT FOR PROGRESS REPORT
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. Period of Report
11. Methodology followed till end of period of reporting
34
ANNEXURE-B1
12. Interim modification of objectives/methodology, if any (with justifications)
13. Summary on progress (during the period of report)
14. Milestones with deliverables achieved during the reporting period as
proposed in the scheme
15. Value of the project applied
16. Expenditure status
17. Research work which remains to be done under the project
Signature of PI: Date:
Signature of Head of the Institute: Date:

CCRH Research Policy
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
35
ANNEXURE-B2
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. Procurement/usage of Equipment
S.
No.
Name of
Equipment
Make/
Model
Cost
FE/Rs
Date of
Installation
Utilization
rate %
Remarks regarding
maintenance/breakd
own
17. Manuscript for Publication (3000 words for possible publication in Council‟s Journal).
18. Constraints if any
19. Financial status
Forwarded by Head of the Institute:
(Name and signature with date)
Name and signature with date
1. __________________________
(Principal Investigator)
2. __________________________
(Co-Investigator)

CCRH Research Policy
36
Annexure -2
Sub: Guidelines/procedures for sharing or monies realised from licensing of
Intellectual Property, and fees from contract R&D and S& T Services with CSIR Staff.
1.BACKGROUND
In accordance with the provisions of the Resolution of the Govt. of India setting up the CSIR, a portion
of monies realised from licensing of Intellectual Property and the fees from sponsored research
projects/schemes was being shared with the staff. However in 1977 on the recommendations of a
Group of Ministers constituted by the president CSIR, the Governing Body decided that the
distribution of monies realised from licensing of Intellectual Property and fees from sponsored projects
contracted after 30th September 1977 be discontinued.
A Committee constituted in 1993 by DG, CSIR on "Marketing of Knowledge base : Set up, Staffing
pattern and Incentives" with Dr.R.A.Mashelkar as Chairman inter-alia recommended revival of sharing
with the CSIR staff, of monies realised from licensing of Intellectual Property and fees from contract
R&D and S&T Services. This recommendation of the Committee was approved by the Governing
Body in its 131st meeting held on 29th July, 1993 with minor modification in pattern of distribution of
the monies/fees among the staff. The CSIR Society in its meeting held on 22nd March, 1994
concurred with the decision of the GB.
2.GUIDELINES
The consolidated guidelines for sharing of monies from licensing of Intellectual Property and
Intellectual fees from Contract R&D and S&T Services with the CS1R staff are as under:
2.1. The monies/fees realised from: (a) Intellectual Property referred to NRDC (b) Intellectual Property
licensed directly by lab. & (c) Sponsored Projects for which agreements were contracted upto 30 th
September, 1977 are to be shared as follows:
Monies realised from Intellectual
Licensing Through NRDC
NRDC Share 30%
CSIR Share 30%
Investigators'(employees') Share 40%
Fees from Sponsored
Property R&D Projects
Direct by Lab.
60% 60%
40% 40%
The pattern of distribution of the portion designated as Investigators' share amongst the staff is to be
as follows:
Staff Share
i. Innovators 35%
ii. Other members of the team 35%
iii. Those who have provided physical and mechanical inputs 15%
directly associated with the project work (ex-gratia)
iv. Common Poll 10%
v. Welfare/Benevolent Fund 5%
2.2. The Investigators' (employees') share of the monies realised from the Intellectual Property
referred to NRDC/released direct by the lab. between 1. 10. 1977 and 31.3.1994 and of the
fees from sponsored research projects for which agreements were executed between these
dates is not distributable amongst the staff.

CCRH Research Policy
2.3 The Governing Body and CSIR Society have now decided to revive the sharing of (a) monies
realised from licensing of Intellectual Property and (b) the intellectual fees from contract R&D
and S&T Services, with the staff as follows:
a) Intellectual Property
Forty percent of the monies realised from licensing of the Intellectual Property
developed and referred to NRDC or approved for direct licensing by competent
authority (MC/DG, CSIR) on or after 1.4.1994 is to be shared with the staff.
b) Contract R&D
Forty percent of the intellectual fee or net surplus (remaining after accounting for all
direct and indirect project expenditure as prescribed in the CSIR Guidelines) whichever
is lower, as rising from R&D contracted on or after 1.4.1994, is to be shared with the
staff.
c) S&T Services
Twenty percent of the intellectual fee or net surplus (remaining after accounting for all
direct and indirect expenditure for the service as prescribed in the CSIR Guidelines)
whichever is lower, arising from S&T Services contracted on or after 1.4.1994, is to be
shared with the staff.
2.4 The Pattern of sharing of the amount earmarked for staff at (a), (b), & (c) above is to be as
follows:
Staff Share
i. Innovators & Principal Contributors 40%
ii. S&T and Other Staff who contribute direct Inputs to the specific 35%
development/activity
iii. Remaining staff of the laboratory 20%
iv. CSIR Welfare Fund(Maintained at HQs) 5%
2.5 The sharing of portion of monies/fees as specified above in para 2.3 is subject to the following:
a) A system of cost accounting has been put in place by the laboratory.
b) A legally valid agreement has been executed for Intellectual property
licensing/contract R&D;
c) The technology transfer/project has been completed in accordance with
the terms of the agreement;
d) The monies/fees due have been received in full;
e) The client has not contested CSIR's fulfilment of its obligations as defined
in the contract/agreement;
f) In the event of any legal action/dispute necessitating refund/payment of
monies/fees by CSIR to the client, the amount paid to the staff is
recoverable;
g) The maximum amount of money receivable by an employee from
licensing of Intellectual Property and intellectual fee from contract R&D
and S&T Services will not exceed Rs.1 lakh per financial year or his/her
salary for the particular financial year whichever is less;
h) The scheme to be reviewed by GB after two years of its operation (i.e.
after July, 1995).
3. PROCEDURES
3.1 Categorisation of Staff
a) Innovators & Principal Contributors may comprise scientists and other S&T staff who have
provided innovative, developmental, design engineering, experimental, data/information,
testing/analytical, repair/fabrication, training and business development/marketing inputs for the
project/activity;
b) S&T and other staff may comprise staff who have provided direct supporting inputs for the
specific project/activity; and
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CCRH Research Policy
c) Remaining staff may comprise rest of the staff of the laboratory who have not been included in
the category of staff at (a) and (b) above for the specific project/activity.
3.2 Maintenance of Project Records
The Head of the laboratory shall ensure that the following records are maintained and retained in the
laboratory:
a) By Project Leader
i. Project File
Document containing information on a systematic basis on initiation of the idea; date of starting
of the project; list of Innovators and Principal Contributors (as defined earlier); responsibilities
of the individuals and extent of their participation (whether whole time or part time); significant
contributions made by the individuals along with the supporting inputs/contributions of the S&T
and other staff.
ii. Completion Report
A document listing the outcome of the Project/activity including the contributions made' by
each of the Innovators & Principal Contributors, S&T and Other staff. The final record shall
be signed by each of the Innovators & Principal contributors and the project Leader.
iii. Project Cost
Expenditure for each project/activity in accordance with Integrated Management & Project
Accounting (IMPACT) System.
b) By Innovators & Principal Contributors and S&T and Other Staff
Record Book
A document maintained individually by the Innovators & Principal Contributors, S&T and other
staff listing date of his/her joining the project; extent of participation (whether whole time or part
time); work allotted and/or undertaken from time to time; contributions or achievement made,
verified and countersigned by the Project Leader/Director.
3.3. Distribution of Monies/Fees
a) A Standing Committee shall be set up by the Director to consider and decide on the share of the
Innovators & Principal Contributors, S&T and other staff from the monies realised from licensing
of Intellectual Property, the intellectual fees of Contract R&D projects and S&T Services.
b) The Project Leader shall recommend to the Standing Committee the share of the individual
Innovators, Principal Contributors and S&T and other staff for a specific project/activity
commensurate with the individual's contributors to the project/activity as reflected in the Project
Records.
c) The Standing Committee shall decide the share of each individual [as at (b) above] in the light of
the recommendations of the Project Leader and taking into consideration the Project Records,
wherever necessary.
d) The recommendations of the Standing Committee shall be intimated to each of the Innovators
and Principal contributors and S&T and other staff and also displayed on the Laboratory and
other appropriate notice boards. In case no objections/representations are received within
fifteen days on the date of notification, then the same can be submitted for consideration and
approval of the Management Council.
e) Representations, if any, against the recommendations of the Standing Committee, within the
stipulated time limit, shall be reconsidered by the standing committee. The Fresh
Recommendations of the Standing Committee, along with the details of representations shall be
put up to the Management Council for Consideration.
f) The decision of the Management Council shall be intimated to each of the Innovators & Principal
Contributors and S&T and other staff and displayed on appropriate notice boards. Distribution of
the monies/fees will then be done if no representations are received against the decision of the
Management Council within thirty days of the date of notification.
g) Appeals against the decision of the Management Council, within thirty days of the date of
notification, can be made to DG, CSIR through the Director of the Lab. Decision of DG, CSIR
shall be final and binding on all concerned.
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CCRH Research Policy
h) The portion of the monies/fees earmarked for the 'Remaining Staff of the Laboratory' is to be
uniform for a salary scale and is to be distributed once a year.
i) A person is entitled for a share from the monies/fees even in the event of his
transfer/retirement/resignation from CSIR. In the event of death of a person, his/her legal heir
shall be entitled for his/her share of monies/fees.
(CSIR Letter No:9/203/94-TU, dated, June 15, 1994.Ammend. - 4)
39