Final approval of WHO-GMP certificates contingent on State Licensing Authority’s clearance

Final approval of WHO-GMP certificates contingent on State Licensing Authority’s clearance

The Central Drugs Standard Control Organisation (CDSCO) has introduced a new flexibility in the application process for the World Health Organization's Good Manufacturing Practices (WHO-GMP) Certificate of Pharmaceutical Product (CoPP). Pharmaceutical companies can now apply for CoPP certificates via the Online National Drugs Licensing System (ONDLS) even if the product license is still under review by the respective State Licensing Authority (SLA).

However, the CDSCO has emphasized that CoPP or WHO-GMP certificates will only be granted once the product license has been officially approved by the SLA. This change allows companies to initiate both processes concurrently, potentially speeding up the overall approval timeline.

In its official statement, the CDSCO clarified that the applicant must submit a complete and compliant product license application along with all required documents to the SLA. While this application is being processed, the company may also apply for CoPP/WHO-GMP through ONDLS.

The central regulator added that final issuance of the CoPP is conditional upon verification and approval of the product license by the concerned state authority, including validation of any previously issued license data, if applicable.

All State Licensing Authorities strictly adhere to the directive.

Earlier this year, the CDSCO had mandated that all applications for WHO-GMP CoPP must be filed exclusively through the ONDLS platform starting July 15, replacing the previous offline process. Due to industry feedback citing onboarding difficulties, the deadline was extended to August 15. The CDSCO conducted training and outreach to help stakeholders transition, and no further extensions were granted.

Despite these efforts, industry representatives have continued to raise issues regarding challenges in using the ONDLS system. Several state regulators have reportedly approached CDSCO to address these operational concerns to avoid delays in processing CoPP applications.

Click here to know more and access the official guidance document

Note:
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