Indian GCP : Trials and Tribulations of a Developing Country

Dr Arun Bhatt

Structure
Evolution of Indian GCP Antecedents Significant differences from ICH GCP Future

Indian GCP a Melting Pot ICMR

Indian GCP
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Indian GCP : Evolution

ICMR 2006 Schedule Y 2005 Indian GCP 2001 ICMR 2000 ICH GCP 1996 Schedule Y 1988
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Reg Gaps Global Trial Conduct Indian Res Milieu

Indian GCP
Local Mishaps Local Trial Conduct
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Indian industry R&D

Indian GCP Antecedents

Global Trials Big pharma / CROs setting up clinical research units ICH GCP Indian R & D Basic R & D and licensing deals with big pharma Generic exports Regulatory Gaps Lack of guidelines to regulate drugs from novel targets / local needs

Indian GCP Antecedents

Local trials EC approval / monitoring / not mandatory Research milieu Low clinical research output Very few global trials Local mishaps Safety issues Consent deviations WHO inspections

ICMR Guidelines Background

Challenge to apply universal ethical principles to biomedical research in the multicultural Indian society with a multiplicity of health-care systems of considerably varying standards

Indian GCP : Bridging the Gap

ICMR Guidelines

Indian GCP

ICH GCP

New Therapy Science Ethics

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Responsibilities Conduct Documentation

Indian GCP a Law

DCGI approval for clinical trial mandates sponsor to follow ethical aspects of the clinical trials as per ICMR and Indian GCP guidelines Indian GCP mandates that clinical research be conducted in accordance with ICMR guidelines and any other laws and regulations of India which ensure a greater protection for subjects.

Ethical Principles of Indian GCP

Focus on Human Protection 5 / 12 principles Essentiality Voluntariness, Informed consent and community agreement Non-exploitation Precaution & risk minimisation Maximisation of the public interest and Distributive justice

Indian GCP : Significant Differences from ICH

Glossary Ethics committee Informed consent process Subject compensation Special groups as research subjects Monitoring Audit Special concerns Appendices
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Glossary
Clinical trial/ study
Phase I Phase II Phase III Phase IV

Principal investigator Co-investigator Monitor

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Ethics Committee
Chairperson independent of the institution
Amended during the evolution ICMR 2000 => Indian GCP => Schedule Y => ICMR 2006

Quorum minimum of 5 members

Amended during the evolution ICMR 2000=> Indian GCP => Schedule Y

Informed Consent Elements

Right to prevent use of biological samples Free treatment of research-related injury Possible current and future use of biological material Risk of discovery of biologically sensitive information

Schedule Y 2005 elements as per ICH GCP

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Subject Compensation
Compensation for participation Compensation for accidental injury Obligation of sponsor to pay

Special Groups
Pregnant or nursing women Children Vulnerable groups
Socio-economically disadvantaged Mentally challenged Prisoners Students, Subordinates, Employees Army personnel

Monitoring
The monitor should promptly inform the sponsor and the ethics committee in case any unwarranted deviation from the protocol or any transgression of the principles embodied in GCP is noted

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Audit
Sponsor should perform an audit as a part of QA system. This audit should be conducted with the purpose of being independent and separate from routine monitoring or quality control functions.

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Special Research Areas

Vaccines Contraceptives Surgical procedures / Medical devices Diagnostic agents radioactive material Herbal remedies and medicinal plants

ICMR Ethical Guidelines 2006

Clinical Evaluation of Drugs/ Devices/ Diagnostics/Vaccines/Herbal Remedies Epidemiological Studies Human Genetics and Genomics Research Research in Transplantation Assisted Reproductive Technologies

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Indian GCP Evolving Future

Guidelines for patient compensation Legislation of ICMR guidelines Biomedical Research Authority
Registration, evaluation and monitoring of ethics committee functioning Mechanisms for enforcing accountability and transparency by the institutions

Regulatory inspections
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