Last Updated on August 22, 2025 by The Health Master
WHO-GMP
The era of shuffling paper applications for WHO-GMP certification is officially over.
In a move that’s been in the works for a while, the Drugs Controller General of India (DCGI) has announced a firm, final deadline: August 15, 2025.
From this date forward, all applications for the World Health Organization (WHO) Good Manufacturing Practices (GMP) (WHO-GMP) Certificate of Pharmaceutical Product (COPP) must be submitted exclusively through the Online National Drugs Licensing System (ONDLS) portal.
No extension
There will be no more extensions, no more physical files, and no more exceptions for WHO-GMP certification.
The DCGI initially set a July 15 deadline for this transition as per the circular dated June 25.
However, some industry associations raised their concerns, emphasizing the need for more time for properly adopting the new online process.
Keeping in view the said concerns, the DCGI provided a one-month extension, extending the final date to August 15, 2025.
What’s Next for the Pharma Industry?
With this final deadline, the DCGI has sent a letter to all the State Licensing Authorities (SLAs) asking them to instruct all manufacturing units in their jurisdictions to adopt the ONDLS portal immediately.
Q: What is meant by WHO-GMP certification?
A: A WHO-GMP Certificate of Pharmaceutical Product (CoPP) is a certificate issued by the drug regulatory authorities, which confirms that a pharmaceutical product is manufactured as per the WHO-GMP standards.
Q: What is the new deadline for online submission of applications for WHO-GMP certification for CoPP?
A: August 15, 2025, is the new deadline for online submission of applications for WHO-GMP certification for CoPP.
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