The Central Drugs Standard Control Organization (CDSCO) has directed manufacturers and state drug controllers (SDCs) to process applications of non-notified medical devices through SUGAM portal. This is applicable to products approved as medical devices which as of today comes under the ambit and definition of drug.
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.
As per CDSCO officials, processing of such applications will be done by new drugs division or import division of CDSCO. Centre for Development of Advanced Computing (C-DAC), Pune has been urged to make provision for the same in the SUGAM portal.
CDSCO receives applications for grant of permission to import various products falling under definition of drug or new drug.
Explore more about Medical Devices, Click here and Click here
“However the CMC, safety and efficacy data of the product should be submitted as per the checklist applicable for medical devices,” informed Drugs Controller General of India(DCGI) Dr V G Somani.
Implementation of e-Governance at CDSCO through SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business.
The project also enables the complete digitization of the old CDSCO records having primarily application within the file, noting in green sheet and supporting documents.
This has enabled the provision for full text and meta data search on the scanned documents retrieval of information across multiple files for a single entity or drug type. The portal also consolidates and publishes data about the various registration certificates (RCs) or licenses being issued by various states Food and Drug administration (FDA) offices in the country.
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.
It has consolidated the entire drug regulatory framework at centre and provides a centralized dashboard for the monitoring the various regulatory clearances all over the country.
The portal is well integrated with the e-Nivesh that is the national portal to provide the project proponent or entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes.
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.