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Govt seeks urgent industry inputs to resolve WHO-GMP COPP certification delays impacting pharma exports
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Shardul Nautiyal, Mumbai
April 21 , 2026
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Government has sought urgent industry inputs to resolve World Health Organization – Good Manufacturing Practices (WHO-GMP) Certificates of Pharmaceutical Products (CoPP) certification delays on the Online National Drug Licensing System (ONDLS) impacting pharma exports.
Exporters have been highlighting festering issues faced while registering for WHO-GMP CoPP on the ONDLS for the past several months. Issues range from technical glitches, timelines, delays in application processing or CoPP issuance and impact on export schedules or commitments.
The CDSCO had mandated that applications for the WHO-GMP CoPP must be submitted online only through the ONDLS portal, effective August 15, 2025. This is aimed to streamline approvals by replacing physical submissions, with the ONDLS serving as a single window for various drug licenses and certificates.
WHO-GMP certifications and Certificates of Pharmaceutical Products are critical documents required for exporting medicines to international markets. Industry representatives, including exporters and MSMEs, have cautioned 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.
This comes at a time when the Central Drugs Standard Control Organization (CDSCO) is also in the process to replace its decade-old SUGAM portal with a new open-architecture digital platform, following final approval from the Department of Expenditure, Government of India.
The existing SUGAM portal, introduced over a decade ago as an e-governance initiative to streamline drug regulation processes, is being phased out after completing its lifecycle. SUGAM has long served as the backbone for regulatory approvals, handling applications related to import and export clearances, manufacturing licenses, and renewals for drugs, cosmetics, and medical devices.
A key component of this evolving digital ecosystem is the ONDLS, which has been introduced specifically for issuing CoPP under the WHO-GMP scheme. Conceptually, ONDLS is meant to centralize and digitize the certification process, ensuring transparency, efficiency, and uniformity across the country. However, in practice, it has emerged as a significant pain point for the industry.
Users report 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 WHO-GMP CoPP certificates, 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.
Industry bodies, including the Pharmaceuticals Export Promotion Council of India (Pharmexcil), have been actively documenting these concerns and are preparing to present a consolidated representation to the CDSCO. Their feedback highlights not only technical shortcomings but also broader compliance challenges arising from updated WHO-GMP requirements, which many companies find difficult to align with through the current system. The delays have a cascading effect, impacting production planning, export logistics, and long-standing international partnerships.
Dr. Rajeev Raghuvanshi, Drug Controller General of India (DCGI), emphasized that the transition to a new digital platform is both necessary and timely. The new digital platform will be 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.
The proposed platform will digitally connect key institutions such as the Indian Pharmacopoeia Commission (IPC), National Institute of Biologicals (NIB), and Indian Council of Medical Research (ICMR), ensuring end-to-end coordination across the regulatory spectrum. The goal is to enable real-time access to information, improve transparency, and significantly reduce approval timelines.
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