Author Topic: icmr and indian-gcp guidelines- rectification  (Read 4907 times)

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Offline radhakrishnan

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Dear forum members,

i know the topic regarding icmr and ich-gcp guidelines has already being discussed. i needed the justification for icmr and indian-gcp guidelines for conucting trials in india. 'WHY DO WE HAVE THE ICMR AND INDIAN-GCP GUIDELINES TOGETHER? WHY THE NEED TO REFER TWO DOCUMENTS? IS THERE ANY SIGNIFICANT DIFFERENCE BETWEEN THE FORMER TWO? PLZ ELABORATE ON THIS QUESTION AS IT WAS ASKED DURING AN INTERVIEW?
Thankyou.

Offline drthakkar

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Re: icmr and indian-gcp guidelines- rectification
« Reply #1 on: Tue, 27 Oct 2009 »
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good topic......

nice if we can have some comments :)

Offline mukul

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Re: icmr and indian-gcp guidelines- rectification
« Reply #2 on: Wed, 28 Oct 2009 »
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Indian GCP is mainly for conducting clinical trial in India, it is a guidance document generated so that every body who is conducting clinical trial follows uniform procedure.

ICMR focus is wide it covers Vaccines, Diagnistics, Herbal Medicines, Epidemiological studies, Genetics research and transplantation etc
Mukul

Offline radhakrishnan

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Re: icmr and indian-gcp guidelines- rectification
« Reply #3 on: Wed, 28 Oct 2009 »
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no satisfactory reply. if iam not wrong both cover all aspectsrelated to biologics, drugs, ayurveda, devices etc.

Offline dryathish.qa

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Re: icmr and indian-gcp guidelines- rectification
« Reply #4 on: Wed, 28 Oct 2009 »
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Dear Radhakrishnan,

The purpose of ICMR guidelines and Indian GCP are subject's rights, safety and wellbeing . But contentwise they are not one and the same. The ICMR Ethical Guidelines For Biomedical Research on Human Participants, as name indicates basically a Ethical guideline for a researcher and addresses the ethical issues like role of Ethics Committee, Informed consent, etc. Whereas the Indian GCP is a guideline ad ressing both the ethics and required practice (Good Clinical Practice) during the conduct of the Clinical Trial. The Indian GCP elaborates the practice in terms of Investigator, Sponsor, CRO (Monitor), etc and guides sponsor/Investigator for the conduct of the study. Where as ICMR talks generally in terms of only Ethics.

Hence to understand ethics we need to read ICMR guidelines and to put that Ethics in to practice we require Indian GCP. One of the best examples is Indian GCP defines what needs to be done by Investigator and Sponsor during the conduct of the study. However, the same can not be seen in ICMR guidelines except Ethics.

Even the Origin of both is different. ICMR Bioethical Guidelines are by Indian Council for Medical Research (ICMR) where as Indian GCP is by CDSCO.

Please reply back for any further clarifications.

Regards,
Dr.Yathish.S
Aim at the sky atleast you reach top of the hill

Offline radhakrishnan

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Re: icmr and indian-gcp guidelines- rectification
« Reply #5 on: Thu, 5 Nov 2009 »
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Dear Dr.yathish,

Thankyou for the clarification rgdng indian-gcp and icmr guidelines.Kindly allow me some time to go through both the documents in case i want  some more clarifications. i guess in some ways your answer is right. Thankyou once again.

Offline anirudhsahoo

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Re: icmr and indian-gcp guidelines- rectification
« Reply #6 on: Tue, 10 Nov 2009 »
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ICMR guidelines give more focus on safety of human being. The Drug which fall under human welfare viz. birth control pills are taken care by ICMR guideline. We have to follow certain points for this. And regarding Indian-GCP, it is the entire guidelines for Clinical trial.
Anirudh Sahoo
Clinical Research

Offline niravbhuva

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Re: icmr and indian-gcp guidelines- rectification
« Reply #7 on: Fri, 13 Aug 2010 »
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good but not enough  ;D

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