32 Extension of timeline for grant of WHO GMP COPP through ONDLS portal 2025-Jul-15 61 KB

Dated : 15.07.2025

==> picture [326 x 86] intentionally omitted <==

----- Start of picture text -----<br> Se aes CDSCO IT-1301 AG 772025<br>CHE ae Government of India<br>LAV yal Directorate General ofHealth Services<br>Ear Central Drugs Standard Control Organization<br>wears suet FDA Bhawan. Kotla Road,<br>New Delhi-110002<br>----- End of picture text -----<br>

To

All State/UTs Drugs Controllers

Subject: Grant of WHO GMP COPP through ONDLS Portal reg.

Sir/Madam,

With reference to Circular No. IT/COPP/ONDLS/2025/001 dated 25.06.2025 regarding the “Grant of WHO GMP COPP through ONDLS portal”, it was directed that all applications for WHO GMP (COPP) shall be mandatorily submitted through the ONDLS portal from 15.07.2025 onwards, and no physical files will be accepted thereafter.

It has come to the attention that several manufacturers are still in the process of registering and uploading documents onto the ONDLS portal. We have also received representations from various industry associations highlighting challenges in onboarding on ONDLS portal and they need more time to complete the process.

In view of these concerns and to support industry interests, the deadline is hereby extended up to 15.08.2025.

In view of the above, you are requested to direct the Manufacturing units under your jurisdiction to submit application for the approval ofWHO GMP (COPP) through ONDLS portal from 15.08.2025. It may be noted that physical files will not be entertained for approval of grant of manufacturing License and WHO-GMP (COPP) from 15.08.2025. Meanwhile CDSCO is organizing multiple knowledge sessions at Zonal/Sub-Zonal levels. Stakeholders may like to attend these sessions for more clarity on the online process, if required.

Further, CDAC may be contacted at uttamkumar@cdac.in or ondlssupport-noida@cdac.in & CDSCO(it-cell@cdsco.nic.in) for any assistance regarding ONDLS portal.

This is for your information and necessary compliance.

==> picture [161 x 72] intentionally omitted <==

----- Start of picture text -----<br> eS Yours faithfully<br>\ Dy<br>(Dx. Raj sin ghuvanshi)<br>Drugs Controller Geheral (India)<br>----- End of picture text -----<br>

Copy to:

All Zonal and Sub-Zonal offices with direction not to accept the application in hardcopy after the deadline mentioned above.