CDSCO Enhances Sugam Portal

February 28, 2025

The Central Drugs Standard Control Organisation (CDSCO) has recently enhanced its digital platform, the Sugam Portal, to facilitate online applications for clinical trial site additions and changes in principal investigators for biological products. This initiative aligns with CDSCO’s ongoing efforts to streamline regulatory processes and improve efficiency in drug approvals.

About Sugam Portal

The Sugam Portal is an online system designed for manufacturers to apply for necessary licenses and approvals from CDSCO.
The portal aims to simplify the submission process for various drug-related applications.
This includes clinical trials for vaccines and rDNA-based drugs, which have now been incorporated into the online application system.

Recent Changes in Clinical Trial Applications

As of December 2024, CDSCO allowed online applications for specific drug types. The recent notification extends this to biological products. Applications for adding clinical trial sites will be deemed approved if there are no objections within 30 days. Changes in principal investigators will also be approved if they meet the established checklist criteria.

Digitisation of Regulatory Processes

CDSCO has been actively digitising its processes. Previous initiatives included the online submission of Periodic Safety Update Reports and other regulatory documents. The move to digital applications aims to reduce processing times and enhance transparency in drug approvals.

Recommendations for Brand Name Database

The Drugs Consultative Committee (DCC) has proposed that the Sugam Portal should include a database of drug products with their brand names. This recommendation aims to prevent confusion caused by similar or identical brand names across different therapeutic categories. The DCC seeks to ensure that the public can access this information to avoid potential medication errors.

Addressing Brand Name Conflicts

The DCC’s proposal marks the need for a system to manage overlapping brand names. If multiple products share a brand name, the first applicant to submit Form 51 will retain the rights to that name. This measure aims to protect patient safety and reduce the risk of prescription errors.

Regulatory Oversight and Human Rights Concerns

The National Human Rights Commission (NHRC) has expressed concerns regarding the use of identical brand names for different medications. Such practices can lead to serious health risks due to confusion in prescriptions. The NHRC has requested detailed reports from health authorities on measures to rectify this issue.

Future Directions for CDSCO

Moving forward, CDSCO plans to build a comprehensive database of pharmaceutical brand names. This will involve collaboration with state drug controllers to gather necessary data. Maintaining accurate records of prescription errors is also a priority to enhance patient safety.

« Previous Post Next Post »