No More Physical WHO-GMP Certificate Applications After August 15: DCGI Alerts Pharma Firms

New Delhi: Reaffirming that no further extensions will be granted, the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), has instructed all CDSCO Zonal and Sub-Zonal Offices to direct manufacturing units under their jurisdiction to submit applications for WHO-GMP Certificates of Pharmaceutical Product (COPP) approval exclusively through the Online National Drugs Licensing System (ONDLS) portal starting August 15, 2025.

Regarding the above, the Drugs Controller General of India has written to all zonal and subzonal offices of CDSCO, directing them not to accept any physical applications for WHO-GMP Certificates of Pharmaceutical Product (COPP) after August 15, 2025.

In view of the above, the notice stated,

"As the final deadline is approaching, it is reiterated that no extension beyond 15.08.2025 will be granted for the physical submission of applications for WHO-GMP (COPP) approval.Hence, you are rcquested to dircct the Manufacturing units under your jurisdiction to submit application for the approval of WHO GMP (COPP) through ONDLS portal from 15.08.2025."

The notice mentioned that as per Circular No. IT/COPP/ONDLS/2025/001 dated 25.06.2025, it was mandated that all applications for WHO-GMP (COPP) must be submitted exclusively through the ONDLS portal starting from 15.07.2025. Accordingly, physical submissions were to be discontinued from that date.

However, considering various representations received from stakeholders and in support of industry interests, the deadline was extended up to 15.08.2025, as communicated vide Circular No. CDSCO IT-13011(12)/7/2025 dated 15.07.2025.

Now, in continuation, it is now re-emphasized that no physical applications/files will be accepted after 15.08.2025 for the grant of WHO-GMP (COPP).

Furthermore, it is highlighted that to facilitate a smooth transition, CDSCO has already conducted multiple physical and hybrid awareness and training sessions at zonal and sub-zonal levels from 21.07.2025 onwards, in collaboration with Centre for Development of Advanced Computing (CDAC) officials. These sessions were attended by state authorities and Pharma stakeholders to address queries and ensure seamless adoption of the online system.

Regarding the above, it is requested that the state licensing authorities (SLAs) ensure proper mapping of the concerned officials along with their respective jurisdictions who are handling these files and that they may be instructed to approve the list of products after due verification.

Additionally, to facilitate the procedure, the notification said, "CDAC may be contacted at uttamkumar@cdac.in or ondlssupport-noida@cdac.in & CDSCO (it-cell@cdsco.nic.in) for any assistance regarding the ONDLS portal."