The Directorate General of Health Services (DGHS) on October 26, 2023, issued a circular regarding Online Applications for Post Approval Changes (PAC) w.r.t Clinical Trial Permission in Form CT-06 and Post Marketing Surveillance (PMS) Study for Human Vaccines and Anti-sera.
The following has been stated: -
•In order to streamline the regulatory submission procedure, the submission of applications for Post Approval Changes (PAC) w.r.t Clinical Trial Permission in Form CT-06 and Approval for Protocol / Report of Post Marketing Surveillance (PMS) Study for Human Vaccines & Anti-sera is functional now through Online System of SUGAM Portal under "Post Approval Changes".
•All applicants seeking the above-mentioned PAC shall apply through the online portal as per the checklist in the module.
•The facility of offline submission of applications in hard copy will not be available for processing from November 01, 2023.
The detailed circular is given in the document attached below.
[Circular No. File No. 7-5/2015/misc./034(e-Governance)]
