India’s drug regulator CDSCO has extended the mandatory online-only submission deadline for WHO'GMP Certificates of Pharmaceutical Product (CoPP) to 15 August 2025, following concerns raised by industry bodies regarding transition delays 

Initially, the regulator issued a circular on 25 June 2025, stating that all CoPP applications had to be filed exclusively through the ONDLS (Online National Digital Licensing System) portal starting 15 July, with no scope for physical submissions. However, due to reports that many manufacturers were still onboarding and uploading required documents, the Drugs Controller General of India (DCGI) approved the extension to 15 August. 

The CDSCO also announced that it will conduct multiple zonal and sub-zonal training sessions to support stakeholders with the new system. State drug controllers have been instructed to guide manufacturers within their jurisdictions to begin submitting online from mid-August onwards.

Industry leaders, including Pharmexcil, had flagged the abrupt transition as a threat to export continuity—particularly to Rest of World markets, which account for nearly 45 percent of India’s pharmaceutical exports. Pharmexcil stressed that alongside domestic bottlenecks like NOC delays, the sudden shift to online-only CoPP submissions could steer overseas buyers toward rival suppliers.

The ONDLS portal, developed in partnership with C-DAC, serves as a unified platform for applications related to manufacturing and sales licences, CoPP and GMP certificates, large-volume parenteral approvals, among other functions. This pivot towards digital licensing aims to standardise regulatory practices across states, improve transparency, and enhance ease of business. 

While the extension grants manufacturers additional time to adapt, the regulator has made it clear that physical CoPP applications will not be accepted after 15 August. Firms are encouraged to attend the upcoming online training sessions and reach out to CDAC for onboarding assistance.