India’s New Online Submission System for Clinical Trial Applications

The number of clinical trials in India has dropped significantly over the last few years. Nevertheless, India’s Central Drug Standard Control Organization (CDSCO) has launched a system to allow online submission and monitoring of clinical trial applications. The system requires the input of information including clinical trial sponsor/CRO, Investigator, Ethics Committee and clinical trial subjects.

CDSCO hopes that the online system will improve transparency, accountability and efficiency in the clinical trial application process.

CDSCO says that it will continue to review clinical trial applications submitted through hard copy until the system for online submission is made fully operational. The online submission system is located at: