The Drugs Controller General of India has directed all zonal and sub-zonal offices of the Central Drugs Standard Control Organization (CDSCO) to stop accepting physical applications for WHO-GMP (Certificate of Pharmaceutical Product – COPP) after August 15, 2025.

Initially, as per a circular issued on June 26, 2025, it was made mandatory to submit all applications for WHO-GMP (COPP) via the ONDLS portal starting July 15, 2025, with physical submissions ceasing from that date.

However, following multiple representations from stakeholders and in support of industry interests, the deadline for discontinuing physical submissions was extended until August 15, 2025, which was communicated through a circular issued on July 15, 2025.

CDSCO has now reaffirmed that no physical applications or files will be accepted after August 15, 2025, for the grant of WHO-GMP (COPP).

To support this digital transition, CDSCO has conducted multiple physical and hybrid awareness and training sessions at zonal and sub-zonal levels in collaboration with CDAC officials starting July 21, 2025.

These sessions were attended by state authorities and pharma stakeholders to address queries and ensure seamless adoption of the online system.

Drugs Controller General of India Dr Rajeev Singh Raghuvanshi has urged the State Licensing Authorities (SIAs) to ensure proper mapping of the concerned officials along with their respective jurisdictions who are handling these files, and instruct them to approve the list of products after due verification.

As the final deadline is approaching, CDSCO reiterated that further extensions will be granted beyond August 15, 2025 for the physical submission of applications for WHO-GMP (COPP) approval.

All zonal and sub-zonal offices of CDSCO are also asked to direct the manufacturing units under their jurisdiction to submit applications for WHO-GMP (COPP) approvals exclusively through the ONDLS portal after this date.