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Difference Between ICH-GCP and Indian GCP

ICH-GCP vs Indian GCP

Good Clinical Practice (GCP) is an international standard set for conducting, formulating, documenting, and reporting clinical trials that may involve humans as participants. It is important to comply with this standard since it provides the public the assurance that the trial subjects’ rights, safety, and well-being are protected, and that data from clinical trials are credible. The goal of the ICH GCP (International Conference on Harmonization of Good Clinical Practice) is to provide a uniform standard for U.S., European Union, and Japan to facilitate the adoption of clinical data by regulatory authorities of the said jurisdictions. The guidelines should be followed when data from clinical trials should be submitted to regulatory authorities.

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 investigators.

SOPs from investigator and sponsors are at issue. The Indian guidelines state that the copy for the SOPs must be duly signed by both the investigator and the sponsor. The investigator, with his research team, should comply with the SOPs. This may be impossible since it will become a huge burden for sponsors to get the SOPs signed by all the investigators of the trial. The entire process of maintaining several SOPs and making revisions are complex enough.

The role of the investigator in data analysis, according to the ICH-GCP, is to submit a recap of the trial and its outcomes to the Sponsor and its Ethics Committee, while the Indian GCP mentions that the investigator or the institution should analyze the data, make a study report, and submit it to the Sponsor and Ethics Committee. This tends to double the workload of the busy investigators and Ethics Committee. In addition, this will result in various study reports for various sites of a similar study.

The Indian version added fresh headings to the Informed Consent Section of the ICH-GCP, pertaining to biological samples like genetic material. The Indian GCP offers patients the freedom to choose not to make the samples collected for analysis available for possible future use; considering that there is a possibility that the samples can be shared at any time. This section may create a conflict in the Informed Consent Process and might discourage patients from enrolling in clinical trials.

According to the ICH-GCP, the monitor is the one who is responsible for verifying how legible the documents are which are provided by the investigator or the site. It does not mention that it would be mandatory to verify the informed consent processes’ revisions. The Indian GCP states that the monitor should inform the Sponsor and Ethics Committee of any deviations from and violations of the protocol, including the ICF (informed consent form). This may be impossible since the monitor does not have direct contact with the Ethics Committee.

Lastly, after all the considerations are reviewed, it can be stated that the creation of the Indian GCP came to happen so that the good deeds will be anticipated, but it will be more applicable if the implications are made easy to comply with.

Summary:

  1. The Indian GCP may have some guidelines that are hard to comply with compared to the ICH-GCP.
  2. In the Indian GCP, both investigator and sponsors should sign the SOPs. ICH-GCP expects the investigator to comply with SOPs and leave the monitoring of SOPs to the auditors and monitors.
  3. In Indian GCP, the retained body samples (genetic material) may not be reused for future trials when there is a need to repeat it.
  4. ICH-GCP states that the monitor should be the one to verify the legibility of documents, while Indian GCP states that the monitor also needs to inform the Sponsor and Ethics Committee for any violations from the protocol.

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