The Central Drugs Standard Control Organization (CDSCO) has directed the concerned stakeholders to file online applications of veterinary drugs on the new SUGAM module. The aim of the exercise is to initiate a comprehensive e-Governance programme to fast track approvals and bring in transparency in the operations.
No physical application will be received from August 15, 2019 onwards in this regard, the CDSCO notice stated.
A new SUGAM module for filing online applications of veterinary drugs has been launched on the portal. All stakeholders are requested to use this facility and any suggestions to improve the services shall be addressed appropriately, the notice further stated.
Implementation of e-Governance at CDSCO through SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business. It is the project of national importance that directly reflects the Government’s Digital India initiatives and is a major influence in bringing reforms in the Indian pharma industry.
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.
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. SUGAM portal provides high level of transparency to its stakeholders as status of the submitted applications can be tracked from applicant dashboard.
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.
The portal internally builds the database of drugs and manufacturers and their current regulatory status- approved or banned in India.
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