|
The Central Drugs Standard Control Organisation (CDSCO) has launched an IT enabled system for the online submission of applications and monitoring of clinical trials in the country. The new system is expected to improve transparency, accountability and efficiency in processing of trials of clinical trial applications and its monitoring in the country. However, the online submission of clinical trial application has not been made mandatory at present.
“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 CDSCO in a notice said.
The clinical trials on the new drugs are regulated under the provisions of the Drugs & Cosmetic Rules, 1945, amended from time to time.
All the information related to four major domain of clinical trial i.e. sponsor/CRO, investigator, ethics committee and clinical trial subjects are captured in the system through online in an organised manner which will result in efficient monitoring of clinical trials in the country for protection of right, safety and well being of trial subjects and authenticity of the data generated. In the first phase, an IT enabled system for online submission of applications of clinical trial has been created and made accessible to the stakeholder through http://octams.gov.in.
Applicants wishing to submit their clinical trial application online, can do so through http://octams.gov.in.
Although the online submission is presently not mandatory, the applicants are encouraged to avail the system which will enable CDSCO to process the application in an efficient and expedited manner.
If any applicant faces any difficulty or problem during the process of online submission, the same can be brought to the notice of CDSCO through email at dci@nic.in or phone at 01123236965 for addressing the issues in consultation with NIC, the CDSCO notice said.
|