From Clinical Trials to Commercialization: Perspectives in Human Vaccine

Area of Science:

• Pharmaceutical Sciences
• Regulatory Affairs
• Clinical Trials Management

Background:

• India is a major global vaccine producer and exporter.
• However, India experiences significant delays in launching new therapeutics compared to G20 nations.

Purpose of the Study:

• To evaluate stakeholder perspectives on the New Drugs and Clinical Trial (NDCT) Rules 2019.
• Assessing the coherence, clarity, and operational impact of these rules on pharmaceutical companies.

Main Methods:

• Qualitative analysis of stakeholder feedback.
• Identification of key challenges faced by pharmaceutical companies under the NDCT Rules 2019.

Main Results:

• Three primary challenge clusters identified: regulatory, operational, and systemic.
• Regulatory issues include lengthy approval times and unclear legal frameworks.
• Operational and systemic hurdles involve trial site distribution, capacity, ethics committee delays, and inconsistent guidelines.

Conclusions:

• The NDCT Rules 2019 present significant regulatory, operational, and systemic challenges for pharmaceutical companies in India.
• Addressing these barriers is crucial for accelerating therapeutic launches and improving India's drug development landscape.