few important points on ich gcp

1. ICH - GCP

2. What you see may not be the truth
Why Conduct Research?

3. What is lCH?
What is ICH?
1. International Council of Harmonization.
2. It is a joint initiative involving regulators &
industry as equal partners in the scientific &
technical discussions of the testing
procedures which are required to ensure the
safety, quality & efficacy of medicines.

4. Structure
 Three countries, USA, Japan and EU
 ICH operates via the ICH Steering
Committee.

5. GCP
 An international ethical and scientific quality
standard for designing, collecting, Conducting,
analyzing & reporting clinical trials that involve
the participation of human subjects.
 Provides public assurance that rights, safety
well-being & confidentiality of trial subjects are
protected, consistent with Declaration of
Helsinki and that the clinical data are credible.

6. 13 Principles of ICH-GCP
 Clinical trials to be conducted in acc with ethical
principles that have their origin in the DoH &
consistent with GCP & regulatory requirement(s).
 Foreseeable risks & inconveniences to be weighed
against the anticipated benefit for the individual trial
subject & society.
 The rights, safety, & well-being of the trial subjects
are the most important considerations & should
prevail over interests of science & society.

7. 13 Principles of ICH-GCP
The available non-clinical and clinical
information on an investigational product
should be adequate to support the proposed
trial.
Clinical trials should be scientifically sound, &
described in a clear, detailed protocol.
A trial should be conducted in compliance with
the protocol that has received prior IRB/IEC
approval/favorable opinion.

8. 13 Principles of ICH-GCP
The medical care given to, & medical decisions made on
behalf of, subjects should always be the responsibility
of a qualified physician .
Each individual involved in conducting a trial should be
qualified by education, training, & experience to
perform his/her resp task(s).
Freely given informed consent should be obtained from
every subject prior to clinical trial participation.

9. 13 Principles of ICH-GCP
All trial information should be recorded,
handled, and stored in a way that allows its
accurate reporting, interpretation & verification.
Confidentiality of records that could identify
subjects should be protected.

10. 13 Principles of ICH-GCP
Investigational products should be manufactured,
handled, & stored in acc with current Good
Manufacturing Practice (cGMP).
 Systems with procedures that assure the quality of
every aspect of the trial should be implemented.

11. ICH-GCP
Q – How does the ICH-GCP ensure ethical
research?
By laying down guidelines to be
followed by:
IEC/IRB
Investigator
Sponsor

13. “It is widely recognized that India offers
unique opportunities for conducting
clinical trials, because
Large patient pool
Well-trained investigators
Premier medical institutes
Considerably low costs, per patient
Diversity Geo & Genetic
GCP-INDIA

14. India – Ideal Destination for
Clinical Trials
 700,000 specialty hospital beds, 221 medical
colleges
 Skilled English-speaking medical personnel.
 Biggest advantage is the low cost.(Rabo
study) e.g. trials for a standard drug in the
United States can cost about $150 million. A
similar drug could be tested in India at a 60
per cent reduction of that whopping cost.

15. Questions?

16. Thank You!