Regulatory Affairs

Regulatory Process: CDSCO

Based on the molecule, type of the application will be decided (Subsequent New Drug or Global Clinical Trial)
Application will be reviewed by drug inspector in first 4 week and prepare summary for expert review
Subject Expert Committee (SEC) meeting
Changes in the Regulatory Process since 2013 has resulted in reduced timelines for granting approvals

Submission of application to SEC members by CDSCO along with the summary, and confirmation of adequacy for further review of the application
SEC members to review and provide feedback in prescribed template in writing through email to CDSCO
SEC members feedback (in case of queries / clarification / modifications / suggestions) compiled and shared with applicant by CDSCO
Applicants to respond to SEC members comments
Presentation to SEC by applicant in post response by applicant (if a response is applicable)
Applicant response accepted by SEC/CDSCO or if applicants response need further deliberation response put up in immediate next SEC meeting
Publication of SEC Recommendation on CDSCO website within 3 working days after finalization of minutes
If accepted by SEC / CDSCO issue of permission by CDSCO