Online National Drug Licensing system from April 15: DCGI

The applicants and regulators involved in processes have been urged to avail this facility of testing followed by operationalization - DCGI

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DCGI CDSCO

Last Updated on April 7, 2021 by The Health Master

To bring uniformity, traceability and accountability in evaluation and disposal of licenses, the Drugs Controller General of India (DCGI) has directed state licensing authorities (SLAs), drug testing labs and pharmaceutical associations to implement e-governance through online national drug licensing system which can be accessed through https://statedrugs.gov.in from April 15, 2021 onwards.

https://statedrugs.gov.in

The same has been made functional for testing with effect from March 31, 2021 for validation of the system. Online national drug licensing system will be shifted from validation mode to operational mode for all purposes with effect from April 15, 2021 onwards.

The applicants and regulators involved in processes have been urged to avail this facility of testing followed by operationalization,” the DCGI in a notice stated.

As per the DCGI notice, this is to inform that the issue of developing an online portal for issuance of sales and marketing license has been discussed in various Drugs Consultative Committee (DCC) meetings and Central Drugs Standard Control Organisation (CDSCO) has taken this task for development of such online portal to bring uniformity, traceability and accountability in evaluation and disposal procedure of such applications for issuance of licenses or certificates across the country for the benefit of all the stakeholders.”

Online
Picture: Pixabay

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CDSCO in pursuance to implement e governance had launched various online services through Sugam portal on November 14, 2015.

The DCGI had also directed all SLAs and manufacturers for online submission of applications for issuance of Form 41 (Registration Certificate) and Form 10 (Import License) for veterinary vaccines through Sugam portal.

The applicants seeking for such certificates/licenses may now apply through online Sugam portal as per the checklist in the developed modules. The facility of offline submission of applications in hard copy may not be available after March 25, 2021 for processing, according to a CDSCO notice.

Sugam is an e-Governance system to discharge various functions performed by CDSCO under Drugs and Cosmetics (D&C) Act, 1940. The software system developed is an online web portal where applicants can apply for NOCs, licenses, registration certificates, permissions and approvals.

It provides an online interface for applicants to track their applications, respond to queries and download the permissions issued by CDSCO. It also enables CDSCO officials to process the applications online and generate the permissions online and generate MIS reports.

It contains step-by-step guidance to the applicants of the Sugam portal with screenshots of the workflow for various application submissions.

Following sections which are detailed in Sugam are user registration and login, applicant dashboard, managing sub login accounts, form submission for various processes and post approval changes.

Applications were made in hard copy dossier format to various divisions in CDSCO before the Sugam portal was introduced. The timelines for granting permissions or approvals for applications were almost three times more than what is there in the current scenario.

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