An IT enabled system has been launched by the Central Drugs Standard Control Organization (CDSCO) for the online submissions of the applications for clinical trials and its monitoring. The CDSCO is the regulatory body of India responsible for thee registration of medical devices, drugs, IVDs and cosmetics. The previous blog article of Morulaa HealthTech has a detailed explanation of In Vitro Diagnostics (IVD) registration in India. READ ALSO: The achievements of the CDSCO in 2014. This method would increase the transparency and efficiency of the process in the country. The CDSCO notice read “In order to improve transparency, accountability and efficiency in processing of trials of clinical trial applications and it’s monitoring, CDSCO with the approval of ministry of health and family welfare, government of India has taken initiative to create an IT enabled system for online submission of applications and monitoring of clinical trials in the country”
The regulation of clinical trials for new drugs is under Drugs & Cosmetic Rules, 1945 provisions which is timely amended. This online application system is currently not mandatory but applicants wishing to submit clinical trial application are encouraged to submit through http://octams.gov.in. For better understanding the clinical trial application find the list of the documents required for the clinical trials in India. In case of problems faced, connect with the CDSCO via email (dci@nic.in) or phone (01123236965) as given in the CDSCO notice.
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