PXL/HO/Cir-003/2026-27                                            Date: 16.04.2026

Hyderabad

Subject: Issues faced while registering for WHO-GMP or COPP on ONDLS system – Data Request – Reg.

Members are kind aware, the Online National Drug Licensing System (ONDLS) is being implemented for the issuance of Certificates of Pharmaceutical Products (COPP) under the WHO GMP Scheme. In this context, we have received feedback from a few companies highlighting issues faced during the process. In light of this, we seek your inputs to understand the extent and nature of these challenges across the industry.

To ensure a smooth transition and enable Pharmexcil to effectively represent your concerns to CDSCO, we request your valuable inputs on the following:

1.         Specific Issues Faced:

o          Challenges encountered while applying through ONDLS.

o          Technical glitches or system-related problems.

o          Any difficulties in compliance with the new WHO GMP requirement.

2.         Timelines and Delays:

o          Instances of delays in application processing or COPP issuance.

o          Impact on export schedules or commitments.

Please share your detailed feedback at the earliest (by 18.April. 2026) using the google form: Link

Your proactive engagement will help us address these concerns promptly and ensure seamless implementation of the new system.

With Regards,

Raja Bhanu

Director General