CDSCO Shifts WHO-GMP and COPP Applications to ONDLS Portal

As part of a major step to digitisation of India’s pharmaceutical regulatory processes, the Central Drugs Standard Control Organisation (CDSCO) announced that effective 15 July 2025, all applications for World Health Organisation Good Manufacturing Practices (WHO-GMP) certification and Certificate of Pharmaceutical Product (COPP) will need to be submitted through the Online National Drugs Licensing System (ONDLS) only.

This announcement will completely remove the ability to submit physical applications to the CDSCO, and will enhance operational transparency, efficiency, and compliance Indian pharmaceutical manufacturing sector.

The ONDLS-developed and implemented by C-DAC and the Union Health Ministry, is a single-window for pharmacies to submit a variety of regulatory applications related to drug manufacturing licences, sale permissions, market standing certificates, post approval changes, WHO-GMP, and COPP. This announcement correlates with India's plans for promoting ease of doing business and digital transformation of the pharma regulatory architecture.

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This shift is expected to streamline documentation practices, reduce processing delays, and ensure uniformity in approvals across states and union territories. Since India is a big player in the generic drug manufacturing industry and global pharmaceutical exporter especially of antibiotics and herbal medicines, an approximation and procedural change to this type of format will continue to inspire confidence for other global regulators and trading partners.