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.