2.2 ICMR guidelines, for Research history and branches guidelines

History and branches It is one of the oldest medical research bodies in the world

1. History and Contents of ICMR,
ICH-GCP
GCP-Ayurveda medicine guidelines

2. The Indian Council of Medical Research - ICMR
It is the apex body in India for the formulation,
coordination and promotion of biomedical
research. Established in 1911.
It is one of the oldest medical research bodies in
the world.
History
1911 - Indian Research Fund Association (IRFA)
established by Sir Harcourt Butler on November
15.
1913 - Indian Journal of Medical Research
(IJMR) starts now a leading Peer-reviewed indexed
Journal of Biomedical research

3. 1918: ICMR - NIN : Beri - Beri Enquiry under
Sir Robert McCarrison set up - National
Institute of Nutrition (NIN) at Hyderabad.
(Coonoor)
1919: research on Indigenous Drugs - under
Col. R. N. Chopra at Kolkata : Calcutta School
of Tropical Medicine.
1927: Malaria Survey of India - Central
Malaria Organization known as ‘Malaria
Survey of India ‘ forms under the guidance of
lt. Col. S. R. Christopher with its first station
set up in Karnal.
I Publication of Records of Malaria Survey of
India - renamed as Malaria Institute of India-
Indian Journal of Malariology - Journal of
Vector Borne Diseases

4. 1932: Hygiene and Public Health Centre -
Governing Body of IRFA (Indian Research
Fund Association) sets up - Institute of
Hygiene and Public Health at Kolkata.
1937: Nutritive Value of Indian Food - ‘ The
Nutritive Value of Indian Foods and Planning
of Satisfactory Diets’ - published first time.
1941: First ever Biomedical Research
Fellowship scheme is initiated by IRFA aimed
at nurturing health research in India.
1942: Transmission cycle of the Parasite of
Kala-azar is elucidated, which helps in
prevention and control of the disease.

5. 1944: Dietary allowances: Recommended
Dietary Allowances (RDA) are made for the
first time for Indian context and are updated
every 10 yrs.
1949: Filariasis control: National Programme
for Control of Filariasis in association with
Malaria Institute of India is initiated.
1949: IRFA as ICMR: IRFA is renamed to as
Indian Council of Medical Research.
1951: Virus research centre set up in Pune -
known as National Institute of Virology (NIV)
1952: Bombay Blood Group - A new blood
group - discovered by Dr. H. M. Bhatia - which
saves numerous lives.

6. 1954: NIRRH - Contraceptive testing Unit and
Reproductive Physiology Unit set up in Bombay
- National Institute for Research in
Reproductive Health (NIRRH)
1956: NIRT - Tuberculosis Chemotherapy
centre at Madras - National Institute for
Research in Tuberculosis.
1957: Kyasanur Forest Disease - known as
Monkey fever discovered in Sagar - Soraba
district of Karnataka
1957: NIIH: Blood group Reference Centre
established at Bombay - National Institute of
Immunotherapy

7. 1959: NARFBR - ICMR takes over Laboratory
of Animal Information Services Centre (LAISC)
established in the Campus of Cancer Research
Institute at Bombay. Later shifted to
Hyderabad - now functioning as National
Animal Resource Facility for Biomedical
Research (NARFBR) since 2016.
1960: ICMR Headquarters constructed at New
Delhi
1962: Established Cholera research Centre -
National Institute of Cholera and Enteric
Diseases (NICED)
1965: Set up Indian Registry of Pathology -
National Institute of Pathology (NIP)

8. 1966: Set up Occupational Health Research at
Ahmedabad - National Institute of Occupational
Health (NIOH)
1968: Iron-folate supplement is recommended
to pregnant women, - national programme at
1970.
1970: Night Blindness - National Prophylaxis
programme against Nutritional Blindness due to
Vitamin - A deficient is initiated after a series of
trials by ICMR.

9. 1971: Home available fluids: Demonstration of
Oral Rehydration Therapy (ORT) to prevent
mortality due to Diarrhea is carried out. Home
Available Fluids (HAF) such as Sherbat (Salt,
Sugar, Lemon) or tender coconut water and
pressed rice water is found to be effective as
well.

10. 1973: Goiter - Demonstrate iodized salt
controls endemic Goiter Prevalence.
1975: VCRC - Vector Control Research Centre
is established at Pondicherry.
1976: NJILOMD - takes over Central JALMA
Institute for Leprosy at Agra, established by
Japanese Leprosy Mission for Asia (now known
as National JALMA institute for Leprosy and
other Mycobacterial Diseases - Agra
NIMS - Institute for Research in Medical
Statistics (IRMS) is set up now known as
National Institute of Medical Statistics - Delhi.

11. 1977: - Malaria Research Centre is established
at Delhi now known as National Institute of
Malaria Research (NIMR).
1979: The Cytology Research Centre is set up
in New Delhi now known as National Institute
of Cancer Prevention and Research( NICPR)-
Noida.
1980: CHINGLEPUT TRIAL - largest ever trial
demonstrates inefficiency of BCG Vaccine in
Adults.
HEPATITIS - E TRIAL : Human Hepatitis E
virus discovered.
ETHICS POLICY: Policy on Ethical considerations
involved in Research on Human subjects released.

12. 1980: The national Cancer Registry Project
starts with the establishment of Population
and Hospital based Cancer Registries.
1981: RMRC-B: Regional Medical Research
Centre at Bhubaneswar is set up.
1983: RMRC-PB: Regional Medical Research
Centre at Port Blair is set up.
1984: - Regional Medical research Centre for
Tribal Health at Jabalpur is set up - now
known as national Institute of research in
Tribal Health (NIRTH).
1986: TEST TUBE BABY - ICMR partners in India’s
scientifically established test tube baby at Mumbai.
( National Institute for Resaerch in Reproductive
Health(NIRRH).

13. 1990: PG Course in Medical Entomology -
Initiated MSc. in Public Health Entomology -
the only course of its kind offered in India.
1992: - National AIDS Research Institute at
Pune (NARI).
1994: NIE - National Institute of Epidemiology
at Chennai.
2003: Polio Research - ICMR contributes to
Polio Research and Global Polio eradication
programme and helps in achieving Polio free
status in India.
2005: ICMR Junior Research Fellowship (JRF)
is initiated to support young scientist to
pursue research.

14. 2006: - Regional Medical research Centre
(RMRC), Belgaum is set up - now known as
National Institute of Traditional Medicine -
Belagavi (NITM).
2007: CTRI - Clinical Trial Registry of India, a
free and online Public record system for
registration of clinical trials being conducted in
India is launched.
2008: School of Public Health is established at
National Institute of Epidemiology at Chennai.
2010: - National Institute for Research in
Environmental Health (NIREH) is established at
Bhopal.

15. 2011: Lineage 1 west Nile Virus - highly
pathogenic lineage with outbreak potential in
western countries, is detected for the first time
in India, Kerala.
2011: National Centre fro Disease informatics
and Research (NCDIR) is set up at Bangalore.
2013: MRU - ICMR initiates establishment of
networks of Multi-Disciplinary Research Units
(MRUs). Model Rural Health Research Units
(MRHRUS), Viral research and Diagnostic
Laboratories (VDRLs).

16. 2013: JENVAC Vaccine - Indigenous Vaccine ‘
‘JENVAC’ for Japanese Encephalitis is
launched.
2015: Dried Blood Spot (DBS) - collection kit
for sub-clinical deficiency of Vitamin A and an
ELISA-based kit to estimate iron in the blood
are launched.
2016: ICMR develops a Micronutrient mix,
containing seven micronutrients to fight
against Anaemia.
2017: Occupational Safety - Personal cooling
garments for workers operating in high
temperatures are developed.

17. 2018: RMRC-G , Regional Medical Research
Centre Gorakhpur is set up by upgrading the
NIV field unit established in.
2019: Ethics guidelines - ICMR ‘ National
Ethical Guidelines in Biomedical and Health
Research involving Human participants -
2017’ became legally binding under new Drugs
and Clinical trial Rules, 2019.
Ethics Registry - National Ethics Committee
Registry for Biomedical and Health Research
(NECRBHR) is set up also known as the
NAITIK Portal.

18. 2019: Antimicrobial Resistance Hub and
National Repository of Antimicrobial Resistant
bacteria (NRAMRB) is inaugurated at Kolkata.
2020: SARS-CoV - 2 : is first reported in India
by NIV Pune.
Isolated the Virus.
Developed RT-PCR and ELISA for diagnosis.
Transmission electron microscopy image of
SARS-CoV-2.

19. International Council for Harmonisation (ICH)
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an
International, Ethical, Scientific and Quality
standard for the conduct of trials that involve
Human participants.
A standard for the Planning, Initiating,
Performing, Recording, Oversight, Evaluation,
Analysis and Reporting of clinical trials that
provides assurance that the data and reported
results are reliable and the rights, safety and
well-being of trial participants are protected.

20. Guideline Scope
This guideline applies to Interventional
clinical trials of investigational products which are
intended to be submitted to regulatory
authorities.
This guideline may also be applicable to
other interventional clinical trials of
investigational products which are not intended to
support marketing authorisation applications in
accordance with local requirements.

21. This ICH-GCP Guideline is composed of
principles and annexes that expand on the
principles, with specific details for different
types of clinical trials.
Principles of ICH-GCP
Clinical trials are a fundamental part of clinical
research that support the development of new
medicines or uses of existing medicines.
Well-designed and conducted clinical trials
help to answer key questions in healthcare and
drug development.
Their results are essential for evidence-based
healthcare decisions.

22. The principles of GCP are designed to be flexible
and applicable to a broad range of clinical trials.
This guideline, along with ICH, encourages
thoughtful consideration and planning to address
specific and potentially unique aspects of an
individual clinical trial.
This includes evaluation of trial characteristics,
such as:
•Design elements
•Investigational product being evaluated
•Medical condition being addressed
•Characteristics of the participants
•Setting in which the clinical trial is being
conducted
•Type of data being collected

23. The principles are intended to support efficient
approaches to trial design and conduct.
The use of innovative clinical trial designs and
technologies may help include diverse patient
population, as appropriate and enable wider
participation.
Clinical trials should be designed to protect the
rights, safety and well-being of participants
and assure the reliability of results.

24. The safety of the participants should be
reviewed periodically as new safety information
becomes available, which could have an impact
on the participant or the conduct of the trial.
The participant selection process should be
representative of the anticipated population
who is likely to use the medicinal product in
future clinical practice to allow for generalising
the results across the broader population.
The confidentiality of information that could
identify participants should be protected in
accordance with applicable privacy and data
protection requirements.

25. Freely given informed consent should be
obtained and documented from every
participant prior to clinical trial participation.
For potential participants unable to provide
informed consent, their legally acceptable
representative should provide consent.
A trial should always be conducted in
compliance with the protocol that receives
prior IRB/IEC approval/favourable opinion.
Periodic review of the trial by the IRB/IEC
should also be conducted in accordance with
applicable regulatory requirements.

26. There should be periodic review of current
scientific knowledge and approaches to
determine whether modifications to the trial
are needed, since new or unanticipated
information may arise once the trial has begun.
Individuals with different expertise and
training may be needed across all phases of a
clinical trial, such as Physicians, Scientists,
Ethicists, Technology experts, Trial
coordinators, Auditors and Statisticians.
Individuals involved in a trial should be
qualified by education, training and experience
to perform their respective task.

27. The clinical trial protocol as well as the plans
or documents for the protocol execution (e.g.,
statistical analysis plan, data management
plan, monitoring plan) should be clear, concise
and operationally feasible.
Clinical trial processes, measures and
approaches should be implemented in a way
that is proportionate to the risks to
participants and to the importance of the data
collected.

28. Clinical trial-related records should be
retained securely by sponsors and
investigators for the required period of time
and should be available to regulatory
authorities upon request to enable
reconstruction of the trial conduct and results
in order to ensure the reliability of trial
results.
Investigational products used in a clinical trial
should be manufactured in accordance with
applicable GMP standards.
Manufacturing, Handling, Labelling of
products should be undertaken in a manner
that aligns with treatment assignment and
maintains blinding, where applicable.

29. Clinical Trial
Any interventional investigation on human
participants intended to discover or verify the
Clinical, Pharmacological and/or other
Pharmacodynamic effects of an investigational
product(s); and/or to identify any adverse
reactions to an investigational product(s); and/or
to study absorption, distribution, metabolism
and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.

30. Adverse Event - AE: Any unfavourable
medical occurrence in a trial participant.
Adverse Drug Reaction - ADR:
•In the pre-approval clinical experience
with a new investigational product or its
new usages - unfavourable and
unintended responses, such as a sign,
symptoms or disease related to any dose
of a medicinal product where a causal
relationship between a medicinal product
and an adverse event is a reasonable
possibility.

.

31. •For marketed medicinal products: a
response to a drug that is noxious and
unintended and that occurs at doses
normally used in humans for prophylaxis,
diagnosis or therapy of diseases or for
modification of physiological function.

32. Serious Adverse Event (SAE) : Any
unfavourable medical occurrence that is
considered serious at any dose if it:
•results in death.
•is life-threatening.
•requires inpatient hospitalisation or
prolongation of existing hospitalisation.
•results in persistent or significant
disability/incapacity.
•is a congenital anomaly/birth defect.

33. GCP-Ayurveda medicine guidelines
•Ayurveda medicines
•Patent or proprietary medicine
•Balya / Poshak/Positive health promoter
•Saundarya prakasahak
•Aushadha gana
Medicines intended for internal or external
use for or in the diagnosis, treatment, mitigation
or prevention of disease or disorder in human
beings or animals and manufactured exclusively
in accordance with the formulae described in the
authoritative books of Ayurveda.

34. GCP Guidelines for Clinical trials in Ayurveda
1.Definitions
2.Pre-requisites for the study
3.Responsibilities
4.Record keeping and Data handling
5.Quality assurance
6.Statistics
7.Special concern
8.Appendix: I - IV