In order to promote digital India and ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) has asked for suggestions from the stakeholders to improve Sugam portal for effective online processing of applications.
CDSCO under its e-Governance initiative had 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.
A separate medical device online portal has also been started 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.
As per the plan, all manufacturers and importers of all non-regulated medical devices will register the details of the devices manufactured and imported by them in the special Sugam portal developed for the purpose and a notification will be issued under the D&C Act in this regard.
As per the CDSCO notice, as the “Medical Device” online system (www.cdscomdonline.gov.in) has already been rolled out, it is desirous to obtain feedback from the stakeholder to improve the system. A detailed feedback form has been circulated.
All stakeholders are requested to provide their valuable feedback as per the form with suggestions about short term, medium term and long term measures to be taken to improve the system.
The feedback should be forwarded to firstname.lastname@example.org within two weeks of this notice in scanned pdf format as well as excel document format.
CDSCO envisages uniform implementation of the provisions of Drugs and Cosmetics (D&C) Act,1940 and Rules 1945 to ensure safety and well being of patients by regulating drugs and cosmetics in the country.