The document summarizes the key differences between the Indian guidelines for Good Clinical Practice (GCP) and the International Conference on Harmonisation (ICH) GCP guidelines. Some differences include: the Indian GCP requires investigators to be qualified by the Medical Council of India, while ICH GCP does not; Indian GCP mandates signing standard operating procedures between sponsors and investigators; and Indian GCP gives ethics committees power to discontinue trials, while ICH GCP assigns that role to independent data monitoring committees. Overall, the Indian GCP guidelines include some additional requirements compared to the international ICH standards.

1. DIFFERENCES BETWEEN INDIAN-GCP AND ICH-GCP
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2. INDEX
1> Introduction: Good Clinical Practice (GCP)
2> Differences b/w Indian-GCP & ICH-GCP.
3> Conclusion.
4> References.
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3. INTRODUCTION
Good clinical practice (GCP) is an
international ethical & scientific quality
standard for designing, conducting ,
recording & reporting trials that involve the
participation of human subjects. Compliance
with standard provides public assurance that
the rights, safety & well being of trial
subjects are protected, consistent with the
principle that have their origin in the
Declaration of Helsinki, and that the clinical
trial data are credible. 3

4. The Indian version of GCP is based on the
ICH-GCP, but there are key differences
between the two. Some of the guidelines
found in the Indian version result in the
difficult methodology which becomes
overwhelming for sponsors and investigator.
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5. DIFFERENCES B/W INDIAN-GCP & ICH-GCP
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1. Investigator:
a. Qualification- The Indian
GCP (3.3.1) insists that the
investigator should be qualified
as per the requirement of the
Medical Council of India
(MCI).
b . Responsibility- accordingly
investigator should sign &
forward the data like CRF ,
results ,data analysis from
his/her centre to sponsor &
ethics committee
According to ICH GCP it is
not necessary to be registered
with MCI.
As per ICH GCP the
investigator has to provide a
summary of the outcome of
trial to the independent ethics
committee
Indian GCP ICH GCP

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2. Investigator &
sponsor’s SOPs: the
Indian guideline
mandates that the sponsor
& the investigator should
sign a copy of the
standard operating
procedure.
Besides, the
investigator and his
staff have to be aware
& comply with the
SOPs
Indian GCP ICH GCP

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3. Power of IEC :
accordingly IEC has
power to order
discontinuation of a trial
if the IEC finds the goals
have been achieved or
unequivocal results
obtained.
As per ICH GCP, it is the
responsibility of the
Independent Data
Monitoring Committee
(IDMC) established by
sponsor.
Indian GCP ICH GCP

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4. Essential items for
informed consents:
Indian guidelines cover
issues of biological
samples in the informed
consents form.
As per ICH GCP there is
no information regarding
the biological sample in
informed consents form.
Indian GCP ICH GCP

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5. Monitor:
a. Qualification: Indian GCP
guidelines suggest that the
monitor should have adequate
medical, pharmaceutical and/or
scientific experience.
b. Responsibility: Monitor is
supposed to inform the sponsor
and IEC in case any
unwarranted deviation from
protocol or any transgression
from principles of GCP.
No such specification have
been mentioned as it is an
international guide line.
As per ICH-GCP monitor has
to verify that the documents
provided by the investigator
are legible.
Indian GCP ICH GCP

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6. Document retention:
Indian GCP mandates that
the sponsor should make
arrangements for safe and
secure custody of all study
related documents and
material for a period of
three years after the
completion of the study or
submission of the data to
the regulatory authority
As per ICH GCP
documents are maintained
for 2 yr after getting the
marketing approval
Indian GCP ICH GCP

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6.Drug label:
accordingly the drug
label should contain
name and contact no.
of investigator & name
of the institution
As per ICH GCP it is not
so because this will
lead to practical
difficulties in global
trials.
Indian GCP ICH GCP

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7. No. of IEC members :
maximum no. IEC
members are 12-15.
female gender is must.
Maximum no. of IEC
members are 5.
Both sexes are preferred.
etc.
Indian GCP ICH GCP

13. REFERENCES
 http://www.bioinformatics-india.com
 http://www.authorstream.com
 http://www.clinicalresearchsociety.org
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