Effective from August 15, 2025, the Central Drugs Standard Control Organisation (CDSCO) had mandated that applications for the World Health Organization-Good Manufacturing Practices (WHO-GMP) Certificates of Pharmaceutical Products (CoPP) must be submitted online only through the Online National Drug Licensing System (ONDLS) portal. The purpose of this mandate was to streamline approvals by replacing physical submissions with the ONDLS which serves as a single window for various drug licenses and certificates. CoPP is a critical document required for exporting medicines to international markets. It is a document issued by a country's drug regulatory authority, certifying that a specific drug is manufactured according to WHO GMP standards, enabling its registration and sale in other countries. In India, the CoPP is issued following a mandatory joint inspection of the manufacturing facility by the officials from the CDSCO and the state licensing authority (SLA). This joint inspection ensures compliance with GMP standards before the Drugs Controller General of India (DCGI) issues the CoPP. A joint inspection by zonal/sub-zonal CDSCO officer and SLA is required to verify necessary compliance with GMP guidelines. As per the requirement for first-time applicants, the process begins with a joint inspection after a thorough review of submitted documents. While the CoPP is generally valid for 3 years, a renewed joint inspection of the manufacturing site by the State FDA and CDSCO is necessary for revalidation. The joint inspection ensures that the manufacturing unit maintains required quality controls and adheres to international standards for export. For ayurvedic products, the Ministry of Ayush, CDSCO and SLA conduct joint inspections for CoPP issuance.
But unfortunately, ever since the CDSCO mandated that the applications for the CoPP must be submitted only through online, exporters have been reporting a range of challenges, from difficulty in accessing and navigating the portal to incomplete application submissions, system errors, and lack of clarity in compliance requirements. These issues have led to substantial delays in the issuance of CoPP, directly affecting exporters’ ability to meet shipment deadlines. In many cases, companies, especially those in the MSME segment, are forced to revert to manual submission processes at State Licensing Authorities as a last resort, defeating the purpose of digitization and adding further administrative burden. The government should take note of the fact that recurring technical glitches, prolonged processing timelines, and administrative inefficiencies are disrupting export schedules, jeopardizing contractual commitments, and risking India’s credibility in the global pharmaceutical supply chain. It is really deplorable that the exporters are continuing to face delay in issuance of CoPP through the ONDLS platform for the last nine months ever since the online system was introduced by the CDSCO. According to the industry, owing to this prolonged delay, registrations are presently at a complete standstill, leading to significant operational and regulatory challenges. There can be no two opinions about the fact that the transition to a new digital platform is both necessary and timely. The new digital platform has been designed with a vision for an integrated regulatory ecosystem where all stakeholders, from central and state authorities to laboratories and research institutions, operate seamlessly within a unified interface. By digitising the entire process for issuance of CoPP, the government wanted to enable real-time access to information, improve transparency, and significantly reduce approval timelines. But, the government should act really fast to make the new system seamless as the contractual commitments of several companies are at stake. |