CDSCO, in coordination with CDAC, has developed the ONDLS portal to digitize drug licensing processes. To enhance transparency and efficiency, submission of WHO-GMP (COPP) applications has now been mandated through this portal from 15 July 2025 and replaced physical submissions.

1. Launch of New Online Module on ONDLS Portal – A dedicated module for submission and processing of WHO-GMP (COPP) applications has been integrated into the ONDLS portal by CDAC. This is in addition to existing ONDLS functionalities for sale/manufacturing licenses and blood centre licensing.

2. Mandatory Online Filing from 15 July 2025 – All manufacturing units must submit WHO-GMP (COPP) applications exclusively through the ONDLS portal from 15.07.2025. Physical file submissions will no longer be accepted by CDSCO or state drug authorities from this date.

3. Pre-requisite Data Entry and Approval before COPP Application – Annexure has been attached with the notification to provide for the procedure for submitting an application

1) Manufacturing site registration

2) After registration of manufacturing site, details of the technical staff which are currently on license should be registered.

3) Add all license product through old license management data

4) Add license basic data through old license management data

5) Submit license data to the concern state drug regulatory

6) State drug regulatory approved the license data, new number will be generated against old license number.

7) You can file the application once the data is approved.

4. Designation of Technical Support Contacts – For any issues related to the ONDLS portal:

A.CDAC: uttamkumar@cdac.in, ondlssupport-noida@cdac.in

B.CDSCO IT Cell: it-cell@cdsco.nic.in