PXL/HO/Cir-043/2025-26                                                                                                     Date: 21.07.2025

Hyderabad

Sub: Important Update Regarding WHO GMP and COPP Issuance- request to submit specific technical issues using ONDLS system – reg.

Dear Esteemed Members,

We wish to bring to your urgent attention a recent development concerning the issuance of Certificates of Pharmaceutical Products (COPP) under WHO GMP Scheme. It is a new initiative to mandate the application of WHO GMP for COPPs issued through the Online National Drug Licensing System (ONDLS) system.

The CDSCO is organizing interactive sessions nationwide to discuss this with the industry and bring them on board. Please be aware that this change is expected to have substantial impact on our international commerce if any technical glitches are encountered in application or issuance or even at acceptance at the importing country side.

To facilitate a smooth transition and address any potential challenges, we respectfully request that all exporters and manufacturers:

 * Carefully review the ONDLS system in light of this new requirement.

 * Direct all your queries and concerns to CDSCO.

 * Share a copy of these queries with Pharmexcil at [email dgdesk@pharmexcil.com].

Your detailed input is invaluable. Providing us with specifics will significantly strengthen the ability to represent your interests effectively to the appropriate authorities.

Thank you for your understanding and proactive engagement on this important issue.

With best regards

Raja Bhanu

Director General