The clinical trials on the new drugs are regulated under the provisions of the Drugs &
Cosmetic Rules, 1945, amended from time to time.
In order to improve transparency, accountability and efficiency in processing 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 and processing of application as well as monitoring of clinical trials in the country.
In the first phase, an IT enabled system for online submission of clinical trial applications has been created and made accessible to the stakeholder through http://octams.gov.in. On trial basis, the applicants maynow upload their clinical trial applications online through http://octams.gov.infor the purpose of feedback / suggestions only.
The usual procedure of submission of application physically through hard copy shall continue till the system for online submission is made fully operational and adopted by CDSCO. The suggestions/comments, if any, may please be forwarded to CDSCO through email at dci@nic.in or phone at 011-23236965 for addressing the issues in consultation with NIC.
In the first phase, an IT enabled system for online submission of clinical trial applications has been created and made accessible to the stakeholder through http://octams.gov.in. On trial basis, the applicants maynow upload their clinical trial applications online through http://octams.gov.infor the purpose of feedback / suggestions only.
The usual procedure of submission of application physically through hard copy shall continue till the system for online submission is made fully operational and adopted by CDSCO. The suggestions/comments, if any, may please be forwarded to CDSCO through email at dci@nic.in or phone at 011-23236965 for addressing the issues in consultation with NIC.
