The Central Drugs Standard Control Organisation on 29th September 2021 has notified that submission of applications on Post Approval Changes (PAC) in Bioavailability (BA)/Bioequivalence (BE) study permission and import license for export purpose is functional on online system of Sugam portal.
The facility of offline submission of applications in hard copy or through e-mail may not be available after October 8, 2021, for processing. Applicants seeking for approval of such PACs may now apply through the online portal.
The Sugam e-governance portal has been designed as a single window system for all the stakeholders to access the services provided by the portal, by implementing role based access control and actions. It has consolidated the entire drug regulatory framework at centre and provides a centralised dashboard for monitoring various regulatory clearances all over the country.
