Requirements for Phase Lag in First-In-Human Trials in India: Proceedings of a Panel Discussion

Area of Science:

• Clinical research
• Drug development
• Regulatory science

Background:

• India has improved its clinical research infrastructure and regulations for drug development.
• Historically, concerns regarding participant safety, ethics, and research capacity have limited first-in-human (FIH) studies for non-Indian developed products.
• Addressing these concerns is crucial for expanding global early-phase clinical trial opportunities.

Purpose of the Study:

• To examine the regulatory, ethical, infrastructural, and innovator perspectives on conducting FIH trials in India.
• To identify barriers and facilitators for initiating FIH studies for products developed outside India.
• To inform strategies for strengthening India's position in global early-phase drug development.

Main Methods:

• Convened a multi-stakeholder panel including representatives from regulatory authorities, academia, industry, and funding agencies.
• Conducted a comprehensive review of existing regulatory frameworks and ethical guidelines.
• Analyzed infrastructural readiness and innovator requirements for FIH trials.

Main Results:

• The panel identified key areas for improvement in regulatory clarity, ethical oversight, and research capacity.
• Specific concerns related to data integrity, intellectual property, and long-term participant safety were highlighted.
• Infrastructural assessments indicated a need for enhanced specialized facilities and trained personnel.

Conclusions:

• India possesses the potential to host FIH trials for external products, contingent on addressing identified regulatory, ethical, and infrastructural challenges.
• Collaborative efforts among stakeholders are essential to build trust and ensure participant safety.
• Successful implementation of FIH studies can significantly enhance India's role in global pharmaceutical innovation.