CDSCO Mandates Online COPP Applications via ONDLS Portal

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Dated: 27.06.2025

CDSCO Mandates Online COPP Applications via ONDLS Portal

The Central Drugs Standard Control Organisation (CDSCO) has announced that all applications for the Certificate of Pharmaceutical Product (COPP) must now be submitted only through the ONDLS portal. This directive, issued via the latest circular dated June 2025, marks a critical step in India’s digital transformation of drug regulatory procedures.

What is COPP?

The Certificate of Pharmaceutical Product (COPP) is a WHO-recommended document that certifies that a drug is authorized for sale in the country of origin and is manufactured in compliance with Good Manufacturing Practices (GMP). It is a crucial requirement for Indian pharma exporters seeking market access in many developing and regulated countries.

What is the ONDLS Portal?

The Online National Drug Licensing System (ONDLS) is an integrated digital platform launched by CDSCO to consolidate all drug licensing, import/export certification, and registration activities under one roof. The system aims to reduce physical paperwork, increase transparency, and speed up regulatory approvals.

Key Changes Introduced

Mandatory Online Filing of COPP Applications: All manufacturers seeking COPP certification must now apply exclusively through the ONDLS portal.
No Physical Submissions Accepted: Manual or offline applications will no longer be processed by Zonal or Sub-Zonal CDSCO offices.
Digital Verification and Tracking: Applicants can monitor application status, receive deficiency letters, and track inspection timelines directly via the portal.
Centralized Processing: The system enables harmonized documentation review across all CDSCO offices, ensuring uniformity in COPP issuance.

Impact on Industry Stakeholders

Pharma Exporters: Must onboard their licensing teams to the ONDLS system and familiarize them with digital workflows.
Regulatory Professionals: Need to adapt SOPs to comply with electronic submissions and ensure proper document digitization.
CDSCO Zonal Offices: Will act as facilitators for inspections but no longer manage COPP applications manually.

Benefits of the ONDLS Integration

Enhanced transparency and accountability
Faster processing and reduced turnaround time
Improved data management and digital record-keeping
Elimination of regional disparities in documentation scrutiny
Seamless coordination between CDSCO HQ and zonal authorities

Conclusion

CDSCO’s directive to route all COPP applications through the ONDLS portal is a significant leap towards regulatory modernization. By digitizing export-related approvals, India strengthens its position as a trusted global pharma supplier, ensuring efficiency and credibility in compliance processes.

All pharmaceutical exporters and manufacturing units are advised to register and begin filing COPP requests via the ONDLS portal immediately to avoid processing delays.

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Source: CDSCO

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