The CDSCO now allows applicants to apply for COPP/WHO-GMP certificates even while their product licenses are under review by State Licensing Authorities. This parallel processing aims to expedite certification timelines. However, final approval of COPP/WHO-GMP will only be granted after the product license is officially approved and verified by the concerned authority.
In a significant update, the Central Drugs Standard Control Organization (CDSCO) has announced that applicants may now submit COPP/WHO-GMP certification requests for products whose licenses are still under consideration by State Licensing Authorities.
This move facilitates parallel processing of product license applications and COPP/WHO-GMP certification, potentially reducing delays in market entry. Applicants must first submit a complete product license application with all required data to the respective State Licensing Authority.
While the license is being reviewed, they may simultaneously apply for COPP/WHO-GMP certification. However, the final issuance of the COPP/WHO-GMP certificate will only occur after the product license is officially approved and any existing license data is verified and accepted.
State Licensing Authorities are instructed to ensure strict compliance with this directive, which is expected to streamline regulatory workflows and enhance efficiency in pharmaceutical certification processes across India.