In a relief to pharmaceutical manufacturers, the Central Drugs Standard Control Organization (CDSCO) has extended the deadline for mandatory online submission of WHO GMP Certificate of Pharmaceutical Product (COPP) applications through the ONDLS portal to August 15, 2025. The earlier deadline of July 15, 2025 has been extended by a month following concerns raised by industry stakeholders.
The extension was announced via an official communication addressed to all State and UT Drugs Controllers. The decision comes in response to feedback indicating that several manufacturers are still in the process of registering and uploading necessary documents onto the ONDLS portal. Industry associations have highlighted onboarding challenges and requested more time to ensure compliance.
It may be recalled, that as per the earlier Circular dated June 25, 2025, it was initially mandated that all WHO GMP (COPP) applications be submitted exclusively through the ONDLS portal from July 15 onward. However, considering the industry’s difficulties, the deadline is now extended to August 15, 2025.
After August 15, 2025, physical files will no longer be accepted for approvals related to WHO-GMP or manufacturing licenses. The CDSCO emphasized that all applications must be processed digitally via the ONDLS platform from that date.
To assist stakeholders in adapting to the new digital process, CDSCO is conducting multiple knowledge sessions at the Zonal and Sub-Zonal levels. Manufacturers are encouraged to participate for better clarity on the system.
For technical support or issues related to ONDLS onboarding, manufacturers can contact CDAC at: