CDSCO ENHANCES SUGAM PORTAL FOR BETTER REGULATORY OVERSIGHT

GS2 GOVERNANCE: 

Key Updates

• CDSCO has upgraded the Sugam Portal to streamline clinical trial site additions and changes in principal investigators for biological products.
• This move aligns with ongoing efforts to digitize regulatory processes and improve efficiency in drug approvals.

About the Sugam Portal

• A digital platform for manufacturers to apply for licenses and approvals from CDSCO.
• Now includes online applications for vaccines and rDNA-based drugs.

Recent Enhancements

• From December 2024, online applications for specific drug types were introduced; now extended to biological products.
• Clinical trial site approvals will be automatically approved if no objections are raised within 30 days.
• Changes in principal investigators will be approved based on predefined criteria.

Digital Transformation in Drug Regulation

• CDSCO has previously digitized Periodic Safety Update Reports and other regulatory filings.
• Online applications aim to reduce processing times and increase transparency.

Brand Name Database & Regulatory Measures

• The Drugs Consultative Committee (DCC) recommends a brand name database on Sugam to prevent confusion from identical drug names.
• If multiple companies apply for the same name, the first Form 51 applicant retains rights.
• The National Human Rights Commission (NHRC) has raised concerns over duplicate brand names causing prescription errors and demanded corrective measures.

Future Plans

• CDSCO will collaborate with state drug regulators to compile a comprehensive pharmaceutical brand name database.
• Improving record-keeping of prescription errors remains a key priority to enhance patient safety.