Last Updated on November 5, 2020 by The Health Master
The Central Drugs Standard Control Organisation (CDSCO)’s Sugam portal has approved 1,34,298 out of the total 1,51,724 applications during the lockdown period related to import and registration of drugs, medical device and diagnostics, test license, biologicals, veterinary, BA/BE for export, global clinical trial, new drug, investigational new drugs and fixed dose combinations (FDCs), among others.
Out of the total 1,51,724 applications which included 343 new ones, 2,459 applications are undergoing regulatory protocols and processes.
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.
Earlier the fees for applications were made in the respective bank and then the copy of challan/receipt was submitted to CDSCO office. But now in Sugam portal, fee is calculated according to the applications and can be paid online on the same portal in bharatkosh.gov.in. The receipt for payment is available on the portal which can be downloaded and submitted in the application.
Due to the introduction of the Sugam portal, India is now in the state to compete with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regions.
A separate medical device online portal was also started in line with new Medical Device Rules -2017 (MDR-2017) for applications related to medical devices and in-vitro diagnostics (IVDs).