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Dated: 18.07.2025
CDSCO Extends Deadline for WHO GMP COPP Applications via ONDLS Portal
The Central Drugs Standard Control Organization (CDSCO) had earlier issued Circular No. IT/COPP/ONDLS/2025/001 dated 25.06.2025, mandating that all applications for WHO GMP COPP (Certificate of Pharmaceutical Product) be submitted exclusively via the ONDLS portal starting 15 July 2025.
The decision aimed to streamline the application process, improve transparency, and eliminate delays and redundancies associated with manual filings.
Industry Challenges and Request for Extension
Despite this digital transition, CDSCO received numerous representations from:
- Pharmaceutical manufacturers, and
- Industry associations,
highlighting difficulties in completing the registration and document upload processes on the ONDLS portal. These stakeholders expressed the need for additional time to adapt to the new system.
Revised Deadline Announced
Taking these concerns into account and to ensure a smoother transition, CDSCO has officially extended the deadline:
New deadline: 15 August 2025 After this date, physical file submissions will not be accepted for:
- WHO GMP COPP approvals, and
- Grant of manufacturing licenses.
Instructions to State Drug Controllers
The CDSCO has directed all State/UT Drug Controllers to:
- Inform and instruct manufacturing units under their jurisdiction.
- Ensure all applications are routed via the ONDLS portal from 15 August 2025 onwards.
- Stop accepting hard copy submissions post the extended deadline.
Support Initiatives by CDSCO
To aid the transition, CDSCO is organizing:
- Knowledge sessions at zonal and sub-zonal offices.
- Training and awareness initiatives for pharmaceutical stakeholders to help them navigate the portal.
Support Contacts:
- uttamkumar@cdac.in
- ondlssupport-noida@cdac.in
- it-cell@cdsco.nic.in
Compliance and Regulatory Significance
This digital shift marks a pivotal step toward full e-governance in India’s pharmaceutical licensing regime. Manufacturers and exporters are advised to:
- Register early on the ONDLS portal,
- Upload complete documentation well before the deadline, and
- Attend CDSCO training sessions to avoid last-minute compliance issues.
Conclusion
CDSCO’s extension of the ONDLS portal deadline to 15 August 2025 reflects its responsiveness to industry needs while reinforcing its commitment to a paperless, transparent, and efficient regulatory ecosystem. Stakeholders must treat this extension as a final window to ensure their compliance processes are digitally aligned with national pharmaceutical norms.
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Source: CDSCO
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