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 The Central Drugs Standard Control Organisation (CDSCO) West Zone, Mumbai has successfully rolled out a digital transformation drive with focus on Online National Drugs Licensing System (ONDLS) and related digital services, stated Dr. Santosh Indraksha, deputy drugs controller (India) and head of CDSCO West Zone, Mumbai.
Dr. Indraksha further added, “The CDSCO is advancing a comprehensive digital transformation of India’s pharmaceutical regulatory framework, reinforcing efficiency, transparency, and global alignment across regulatory processes. At the centre of this transformation is the ONDLS, CDSCO’s flagship digital initiative. Initially designed to streamline regulatory processes for blood centres, ONDLS has introduced a standardized and transparent framework for approvals and compliance. By digitizing previously manual workflows, the system has significantly reduced turnaround times while strengthening regulatory oversight.”
Dr Indraksha further informed that as part of digital transformation drive, the CDSCO West Zone, Mumbai, recently conducted a webinar on ONDLS. The session saw participation from over 850 industry professionals, reflecting the increasing reliance on digital regulatory systems. Technical experts from the Centre for Development of Advanced Computing (C-DAC), including Uttam Kumar and Mukesh Kumar Singh, provided detailed guidance on system functionalities, compliance requirements, and best practices, helping stakeholders navigate the evolving digital framework.
Officials added that the efforts to promote digital adoption and fostering collaboration between regulators and industry were commended by Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI). Dr. Raghuvanshi acknowledged the proactive role of CDSCO West Zone and FDA Maharashtra in advancing stakeholder engagement and capacity-building initiatives aligned with Government of India priorities.
Operating under the ministry of health and family welfare, CDSCO has established a digitally integrated ecosystem that is redefining the delivery of regulatory services. Key functions including licensing, certification, compliance monitoring, and export facilitation are increasingly being managed through technology-driven platforms, resulting in faster approvals, improved traceability, and real-time access to regulatory data.
Expanding its scope, ONDLS now facilitates the issuance of World Health Organization Good Manufacturing Practice (WHO - GMP) certificates for pharmaceutical exports. This capability is critical for India’s export-oriented pharmaceutical sector, enabling faster certification while ensuring adherence to international quality standards and reinforcing India’s credibility in global markets.
Complementing ONDLS, platforms such as the SUGAM portal have enabled the digitization of a wide range of regulatory services, including approvals for drugs and medical devices and the issuance of No Objection Certificates (NOCs). Integration with the National Single Window System (NSWS) further enhances efficiency by enabling seamless, end-to-end application processing, reducing redundancies, and improving inter-agency coordination.
According to Dr Indraksha, “CDSCO’s approach to digital transformation is anchored in stakeholder engagement and capacity building. Through regular training programmes, workshops, and webinars, the organization continues to strengthen user capability across industry segments, ensuring effective adoption of digital platforms. CDSCO’s digital acceleration comes at a critical juncture as India strengthens its position as a global pharmaceutical hub amid increasing international expectations around quality, compliance, and supply chain transparency. Robust, integrated digital systems are now central to meeting these demands.”
“By combining technological innovation with policy alignment and stakeholder collaboration, CDSCO’s integrated platforms, anchored by ONDLS and supported by SUGAM and NSWS, are setting a benchmark for modern regulatory governance and enhancing India’s standing in the global pharmaceutical landscape,” he concluded.
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