The Union health ministry will be organizing various workshops this year to sensitise drug and medical device manufacturers to upload details on Sugam portal for effective compliance, timely approvals on licensing and renewals.
The Central Drugs Standard Control Organization (CDSCO) under its e-Governance initiative had earlier rolled out online services for filing of applications through Sugam portal in 2016 for import licensing and registration purpose and offers online licensing services for drugs, cosmetics and biologicals, among others.
Medical device online portal
A separate medical device online portal was also started recently in line with new Medical Device Rules -2017 (MDR-2017) for applications related to medical devices and in-vitro diagnostics (IVDs).
The Union Health Ministry has also recently devised an action plan to regulate all medical devices under Drugs and Cosmetics (D&C) Act to ensure safety, quality and performance of medical devices.
Sugam is mandatory
Uploading of data on Sugam portal is a mandatory exercise.
State licensing authorities are sending out notices to pharmaceutical companies for not uploading data or for uploading incomplete data on Sugam.
Sugam enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. The system also builds up the database of approved drugs, manufacturers and formulations, retailers and wholesalers in India.
Sugam portal provides single window for all its stakeholders to access the services provided by the portal by implementing role based access control and actions.
The portal provides high level of transparency to its stakeholders as status of the submitted applications can be tracked from the applicant’s dashboard.
Ease of business
Sugam enables ease of business by providing the integrated work-flow right from making an application for grant of permission or license, online payment, online review process, query management and grant of permission or license online.