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Regulatory News | 09 September 2015 | By Zachary Brennan
India's Central Drugs Standards Control Organization (CDSCO) has launched a new online submission system for clinical trials as part of efforts to increase transparency, accountability and efficiency in processing trial applications.
CDSCO says the new online system will help in the collection and organization of information on sponsors, contract research organizations, investigators, ethics committees and trial subjects.
The release of the submission system comes as India has seen a steep decline in clinical trial applications and approvals in recent years. Clinical trial guidelines on the subcontinent have been overhauled in the past year, and new rules for compensating for the deaths of clinical trial research subjects have been added. In the first four months of 2015, India approved 19 clinical trials, which compares with 76 trials approved through the first five months of 2014, and 24 trials approved through the first five months of 2013.
CDSCO says it hopes that the creation of such an online system will help to protect the rights, safety and well-being of trial subjects, as well as the authenticity of the data generated.
In the first phase of the launch of the system, the online submission of applications of clinical trials can be made via the website: http://octams.gov.in (editor's note: The website was down as of Wednesday afternoon).
The Indian regulator notes that online submissions are not currently mandatory, though applicants are encouraged to use the system so CDSCO can process applications more quickly.
Tags: India, CDSCO, clinical trials, online submission system