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Industry can apply for WHO GMP CoPP while product license is under consideration of SLA
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Gireesh Babu, New Delhi
October 07 , 2025
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After mandating that the applications for issuance of World Health Organization (WHO) Good Manufacturing Practices (GMP) Certificate of Pharmaceutical Product (CoPP) should be submitted only through online licensing system, the Central Drugs Standard Control Organisation (CDSCO) has said that the industry can apply for the certificate through the system for even products where the product license is under consideration by the State Licensing Authority (SLA).
This is subject to the condition that the grant of CoPP/WHO-GMP should be only after confirming the issuance of product license.
"It has been decided that applicants may now submit applications for issuance of CoPP/WHO-GMP certificate even for products where the product license is under consideration with the concerned State Licensing Authority," said the central drug regulator. The applications are to be submitted through the Online National Drugs Licensing System (ONDLS).
In such cases, the applicant shall first submit the complete license application along with all requisite data to the State Licensing Authority for approval. During the period in which the product license application is under examination, the applicant may simultaneously apply for CoPP/WHO-GMP for the same product.
"However, it is to be noted that before grant of CoPP/WHO-GMP, the concerned State Licensing Authority must ensure that the product license has been duly approved, and that the old license data, wherever applicable, has been verified and accepted," it added.
This implies that the processing of CoPP/WHO-GMP applications can be carried out in parallel with product license applications, but the final approval and issuance of CoPP/WHO-GMP shall be made only after confirmation of product license approval by the State Licensing Authority.
"All State Licensing Authorities are requested to take note of the above and ensure strict compliance," it added.
It may be noted that the CDSCO, in a circular on June 25, mandated that all applications for WHO-GMP CoPP should be submitted only online through the ONDLS from July 15 onwards and no physical files will be accepted thereafter.
The deadline was later extended to August 15, following concerns raised by various industry players, highlighting challenges in onboarding on ONDLS. The drug regulator conducted various awareness meetings and issued documents to help the industry onboard the system within the extended deadline and there was no further extension of the deadline, following this.
Industry experts, however, raised various concerns and challenges to complete the process through ONDLS and have requested the State Licensing Authorities to address the issue so that there would not be any delay in processing their orders. According to sources, some of the State authorities have also raised the request to the CDSCO.
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