CDSCO Introduces Parallel Processing for WHO-GMP COPP Applications

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a significant directive aimed at simplifying the process for obtaining WHO-GMP COPP (Certificate of Pharmaceutical Product) certifications. This new guideline, dated September 26, 2025, introduces a parallel processing mechanism for COPP/WHO-GMP applications alongside product license applications. Here’s what you need to know:

Key Highlights of the Directive

Parallel Submission of Applications: Applicants can now submit COPP/WHO-GMP applications for products even if the product license is still under consideration by the State Licensing Authority. This marks a departure from the earlier requirement where COPP/WHO-GMP applications could only be submitted after product license approval.
Preconditions for COPP/WHO-GMP Approval: While the applications can be processed simultaneously, the final approval and issuance of COPP/WHO-GMP certificates will only occur after the product license has been duly approved by the State Licensing Authority. Additionally, any old license data, if applicable, must be verified and accepted.
Streamlined Workflow: This parallel processing approach is expected to reduce delays and improve efficiency in the certification process, benefiting pharmaceutical manufacturers seeking international market access.
Compliance Mandate: All State Licensing Authorities and zonal/sub-zonal offices of CDSCO have been directed to ensure strict compliance with this new procedure.

Implications for the Pharmaceutical Industry

This directive is a welcome move for pharmaceutical companies aiming to expand their global footprint. By allowing simultaneous processing of product license and COPP/WHO-GMP applications, the CDSCO has addressed a critical bottleneck in the certification process. Manufacturers can now save valuable time, ensuring quicker access to international markets while maintaining compliance with regulatory standards.

Steps for Applicants

To leverage this new process, applicants must:

Submit a complete product license application with all requisite data to the State Licensing Authority.
Apply for COPP/WHO-GMP certification for the same product during the license application review period.
Ensure that all documentation is accurate and complete to facilitate smooth processing.

Conclusion

The CDSCO’s decision to enable parallel processing of COPP/WHO-GMP applications is a progressive step toward enhancing India’s pharmaceutical regulatory framework. By streamlining procedures and reducing delays, this initiative will bolster the industry’s competitiveness on the global stage. Pharmaceutical associations and stakeholders are encouraged to familiarize themselves with the new guidelines and ensure compliance.

In case you face any issues related to Indirect Tax-Customs, GST, Foreign Trade Policy (FTP), Arbitration matters and Central Licensing and related advisory matters in India then please feel free to get in touch with SJ EXIM Services.

We offer Legal advice and litigation support in matters related to Indirect Tax-Customs, FTP, other Indirect Tax matters & Arbitration law, all sorts of Central licensing and related matters. Come and explore the new way of doing business with us!

Source: CDSCO

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