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DIFFERENCES BETWEEN INDIAN-GCP AND

ICH-GCP

By :-Upendra Agrawal

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INDEX

1> Introduction: Good Clinical Practice (GCP)

2> Differences b/w Indian-GCP & ICH-GCP.

3> Conclusion.

4> References.

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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.

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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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DIFFERENCES B/W INDIAN-GCP & ICH-GCP

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

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

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