ICH GCP vs Indian GCP: Difference and Comparison

ICH GCP is a globally accepted standard developed through collaboration among regulatory authorities and the pharmaceutical industry, promoting consistency and harmonization in clinical trial practices worldwide.

In contrast, Indian GCP incorporates local regulatory nuances and requirements specific to the Indian context, emphasizing compliance with the national regulatory framework while aligning with international standards.

Key Takeaways

1. ICH GCP is an international guideline for conducting clinical trials, while Indian GCP is a national guideline specific to India.
2. Both guidelines cover ethical considerations, safety monitoring, and informed consent.
3. Indian GCP includes additional requirements specific to the country, such as needing an ethics committee approval before conducting a clinical trial.

ICH GCP vs Indian GCP

ICH GCP means International Conference on Harmonization of Good Clinical Practice and provides uniform standards to investigate products and release new drugs. Indian GCP is the Indian Good Clinical Practice which requires an investigator with qualifications from the Medical Council of India.

According to the ICH GCP, the investigator has to conduct the consent process and sign the consent form. Also, he has to provide the outcome trial summary to the EC (Ethics committee).

And the monitor is responsible for verifying that the documents provided by the investigator are correct and legible.

The Indian GCP standard insists that the investigator should have qualifications according to the Medical Council of India(MCI). And it is the responsibility of the investigator to sign and forward the data to the ethics committee and the sponsors.

Also, the SOP has to be signed by both the investigator and the sponsor. 

Comparison Table

Feature	ICH GCP	Indian GCP
Full Name	International Conference on Harmonisation Good Clinical Practice Guidelines	Good Clinical Practices Guidelines (adapted from ICH GCP)
Basis	International standard	National adaptation of ICH GCP
Authority	International Council for Harmonisation (ICH)	Central Drugs Standard Control Organization (CDSCO)
Primary Focus	Harmonization of GCP guidelines across regions	Fulfills Indian regulatory requirements for clinical trials
Content	Broad framework for GCP principles	May include additional or more specific requirements compared to ICH GCP
Examples	Informed consent process, investigator qualifications, data management, ethical considerations	Retention period for clinical trial documents

What is ICH GCP?

International Conference on Harmonisation of Good Clinical Practice (ICH GCP) is a set of global standards developed to ensure the ethical and scientific integrity of clinical trials involving human subjects. The guidelines aim to provide a unified framework that promotes the safety, rights, and well-being of trial participants while facilitating the reliability of trial results. ICH GCP is a collaborative effort involving regulatory authorities and the pharmaceutical industry to harmonize practices across regions.

Key Principles

1. Ethical Conduct of Clinical Trials

ICH GCP emphasizes the paramount importance of ethical considerations in conducting clinical trials. It mandates the review and approval of trials by independent ethics committees, ensuring that the rights, safety, and well-being of trial subjects are prioritized. Informed consent is a fundamental requirement, and participants must be fully informed about the study before consenting to participate.

2. Scientific Quality of Clinical Trials

Ensuring the scientific quality of clinical trials is another core principle of ICH GCP. The guidelines stress the need for well-designed and scientifically sound protocols, with clear criteria for participant selection, data collection, and analysis. Investigators are expected to have the necessary qualifications and experience to conduct the study, and trials should adhere to Good Clinical Practice (GCP) standards throughout.

3. Documentation and Record Keeping

Proper documentation and record-keeping are crucial aspects of ICH GCP. The guidelines outline specific requirements for the maintenance of essential documents, including the protocol, informed consent forms, and trial-related correspondence. This ensures the traceability and accountability of all aspects of the clinical trial.

4. Data Integrity and Quality

ICH GCP emphasizes the importance of accurate and reliable data in clinical trials. Systems for data collection, handling, and storage must be robust to ensure data integrity. Source data verification and monitoring activities are recommended to identify and address any discrepancies or errors promptly.

5. Safety Reporting

The safety of trial participants is a primary concern in ICH GCP. The guidelines specify requirements for the reporting and handling of adverse events, with a focus on timely communication between investigators, sponsors, and regulatory authorities. Serious adverse events must be reported promptly, and safety information should be continually monitored throughout the trial.

Compliance and Implementation

1. Regulatory Adoption

ICH GCP guidelines have been widely adopted by regulatory authorities globally. Many countries incorporate these standards into their regulations, making compliance with ICH GCP a prerequisite for the approval of clinical trials and marketing authorization for new drugs.

2. Training and Education

To ensure widespread understanding and application of ICH GCP, training and education programs are essential. Investigators, sponsors, and other stakeholders involved in clinical trials are encouraged to undergo training on the principles and requirements outlined in the guidelines.

3. Continuous Improvement

ICH GCP encourages a culture of continuous improvement in clinical trial conduct. Regular updates and amendments to the guidelines reflect advancements in scientific and ethical considerations, ensuring that the framework remains relevant and effective in safeguarding the well-being of trial participants and the integrity of trial data.

What is Indian GCP?

Good Clinical Practice (GCP) is a set of international ethical and scientific quality standards that ensure the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials are consistent with the well-being of study participants. In India, the regulatory framework for clinical trials follows the guidelines set by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services.

Regulatory Landscape

Under the Indian GCP, the CDSCO plays a pivotal role in overseeing and regulating clinical trials. The regulatory framework is based on the Schedule Y of the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules, 2019. This framework outlines the requirements for obtaining approval to conduct clinical trials, import or manufacture of new investigational drugs, and the responsibilities of investigators, sponsors, and ethics committees.

Ethical Considerations

Ethics play a crucial role in Indian GCP, emphasizing the protection of the rights, safety, and well-being of trial participants. Institutional Ethics Committees (IECs) review and approve trial protocols, ensuring that the research is conducted in accordance with ethical principles. Informed consent, a cornerstone of ethical research, is rigorously upheld to ensure participants fully understand the study and voluntarily agree to participate.

Informed Consent Process

The informed consent process involves providing potential participants with detailed information about the study, including its purpose, procedures, potential risks and benefits, and alternatives. The participant’s voluntary agreement is documented through a signed consent form. The process is transparent, ensuring participants are empowered to make informed decisions about their participation in the clinical trial.

Roles and Responsibilities

Indian GCP defines the roles and responsibilities of various stakeholders involved in clinical trials.

Sponsor Responsibilities

Sponsors are responsible for developing the protocol, obtaining regulatory approval, providing investigational products, monitoring the trial, and ensuring data quality. Adherence to ethical standards and regulatory requirements is paramount, and sponsors must maintain accurate and complete records.

Investigator Responsibilities

Investigators are tasked with conducting the trial as per the protocol, ensuring participant safety, and collecting high-quality data. They must be qualified and experienced, and their facilities must meet the necessary standards. Adherence to the principles of GCP and compliance with regulatory requirements are fundamental to their role.

Monitoring and Auditing

Continuous monitoring and auditing are integral components of Indian GCP to ensure the integrity and reliability of clinical trial data.

Monitoring

Regular monitoring is conducted to verify the protection of participant rights, data accuracy, and protocol adherence. Monitoring activities include site visits, data verification, and ensuring compliance with the approved protocol.

Auditing

Periodic audits are conducted by independent auditors to assess the overall conduct of the trial. Audits focus on compliance with regulatory requirements, GCP principles, and the accuracy of data collection and reporting.

Main Differences Between ICH GCP and Indian GCP

• Regulatory Authority:
  • ICH GCP (International Conference on Harmonisation Good Clinical Practice): A global standard developed by international experts and accepted by regulatory authorities worldwide.
  • Indian GCP: May have specific guidelines and requirements set by the Indian regulatory authorities, such as the Central Drugs Standard Control Organization (CDSCO).
• Documentation and Reporting:
  • ICH GCP: Emphasizes the importance of comprehensive documentation and reporting for clinical trials.
  • Indian GCP: May have additional or specific documentation and reporting requirements mandated by the Indian regulatory authorities.
• Informed Consent:
  • ICH GCP: Provides general guidelines for obtaining informed consent from study participants.
  • Indian GCP: May have specific requirements or considerations for obtaining informed consent in the Indian cultural and regulatory context.
• Ethics Committee Approval:
  • ICH GCP: Stresses the need for ethical review and approval by an independent ethics committee.
  • Indian GCP: May have specific requirements for the composition and functioning of ethics committees in India.
• Investigator Responsibilities:
  • ICH GCP: Outlines the responsibilities of investigators conducting clinical trials.
  • Indian GCP: May provide additional details or variations specific to the roles and responsibilities of investigators in India.
• Drug Import and Export:
  • ICH GCP: Provides general principles for the import and export of investigational drugs.
  • Indian GCP: May have specific regulations related to the import and export of drugs for clinical trials within India.
• Adverse Event Reporting:
  • ICH GCP: Provides guidelines for reporting and managing adverse events during clinical trials.
  • Indian GCP: May have specific requirements for reporting adverse events to the Indian regulatory authorities.
• Monitoring and Auditing:
  • ICH GCP: Recommends monitoring and auditing of clinical trials to ensure compliance with the protocol and GCP.
  • Indian GCP: May specify additional monitoring or auditing requirements in line with Indian regulatory standards.
• Local Regulatory Requirements:
  • ICH GCP: Serves as a global framework, and local regulatory requirements are expected to be followed.
  • Indian GCP: Incorporates specific regulations and requirements set by Indian authorities that may differ from global standards.

References

1. https://www.researchgate.net/profile/Ravindra-Ghooi/publication/315344018_A_Role_of_ICH-_GCP_in_Clinical_Trial_Conduct/links/590874dcaca272f658f6b426/A-Role-of-ICH-GCP-in-Clinical-Trial-Conduct.pdf
2. https://europepmc.org/article/med/12756823
3. https://www.indianjournals.com/ijor.aspx?target=ijor:rjpt&volume=11&issue=7&article=089