CDSCO Sets Final Deadline for WHO-GMP COPP Applications via ONDLS Portal

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Dated: 11.08.2025

CDSCO Sets Final Deadline for WHO-GMP COPP Applications via ONDLS Portal

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has announced a significant shift in the process for granting WHO-GMP (Certificate of Pharmaceutical Product – COPP) approvals. Starting from 15th August 2025, all applications for WHO-GMP (COPP) must be submitted exclusively through the ONDLS portal, marking the end of physical submissions.

Key Highlights of the Announcement:

Mandatory Online Submission:
- As per Circular No. IT/COPP/ONDLS/2025/001 dated 25th June 2025, the initial deadline for transitioning to the ONDLS portal was set for 15th July 2025. However, considering industry feedback, the deadline was extended to 15th August 2025.
- After this date, no physical applications or files will be accepted for WHO-GMP (COPP) approvals.
Awareness and Training Sessions:
- To ensure a smooth transition, CDSCO has conducted multiple physical and hybrid training sessions at Zonal and Sub-Zonal levels since 21st July 2025. These sessions, held in collaboration with CDAC officials, aimed to address queries and familiarize stakeholders with the online system.
Responsibilities of State Authorities:
- State/UT Drugs Controllers are requested to ensure proper mapping of officials handling these applications and verify product lists before approval.
- Manufacturing units under their jurisdiction must be directed to submit applications exclusively through the ONDLS portal.
No Further Extensions:
- CDSCO has emphasized that no extensions beyond 15th August 2025 will be granted for physical submissions. Stakeholders are urged to comply with the new system to avoid disruptions.

Benefits of the ONDLS Portal:

Streamlined Process: The online system ensures faster processing and reduces paperwork.
Transparency: Applicants can track the status of their submissions in real-time.
Ease of Access: The portal simplifies the submission process, making it more efficient for manufacturers and authorities alike.

Support for Stakeholders:

For any assistance regarding the ONDLS portal, stakeholders can contact CDAC officials for guidance. This proactive approach by CDSCO aims to ensure seamless adoption of the online system.

Call to Action:

As the final deadline approaches, all pharmaceutical manufacturers and stakeholders are urged to transition to the ONDLS portal for WHO-GMP (COPP) applications. This move aligns with CDSCO’s vision of modernizing regulatory processes and supporting industry growth.

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Source: CDSCO

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