March 7, 2025
New Delhi

Central Drugs Standard Control Organization (CDSCO) and C-DAC have entered into two distinct Memorandum of Understandings (MoUs) at CDSCO headquarters in New Delhi, signifying a major advancement in digital governance for the pharmaceutical sector, and in alignment with the Business Reforms Action Plan (BRAP) and Digital India Initiative.

Since 2014, C-DAC has played a pivotal role in the creation and implementation of online regulatory processes for CDSCO, facilitating the issuance of manufacturing and import licenses nationwide. The expansion of this collaboration will revolve on two key initiatives: the maintenance and enhancement of the SUGAM Portal, and the development of the Online National Drug Licensing System (ONDLS) for State Pharmaceutical Regulatory Processes.

The SUGAM Portal, which has proven instrumental in facilitating online licensing processes, is scheduled for substantial enhancements over the ensuing two years. The new contract will encompass the integration of supplementary processes and modules, while maintaining and supporting existing services. This enhanced platform is anticipated to yield streamlined regulatory approval workflows, thereby benefiting pharmaceutical companies and regulators alike.

The ongoing project pertaining to the automation of state drug regulation processes, which endeavours to establish connectivity between all 34 CDSCO centers across the nation, pharmaceutical industries, and state authorities, is being advanced. This initiative, funded under the auspices of the Digital India Initiative and BRAP, is being developed to address the escalating requirements of the pharmaceutical sector, thereby ensuring a transparent and efficient regulatory environment.

Pursuant to the newly executed agreements, C-DAC will render continuous support and services for both projects, ensuring adherence to the objectives of CDSCO. The MoUs were signed by the Director of Administration at CDSCO and the GC of e-Governance at C-DAC, thereby symbolizing a mutual commitment to the enhancement of public service delivery through the application of technology.

"Today's signing marks a renewed commitment to fostering a digital ecosystem that not only simplifies regulatory processes but also promotes transparency and efficiency within the pharmaceutical industry," stated the Director of Administration at CDSCO.

C-DAC's contribution to these pivotal projects underscores the organization's dedication to leveraging advanced technology to support governmental functions, enhancing ease of doing business (EoDB) in the pharmaceutical sector, and ensuring compliance with the Drug and Cosmetic Act.

As India continues to embrace digital transformation, the collaborative efforts between CDSCO and C-DAC pave the way for a more dynamic regulatory landscape, reinforcing the nation's position as a leader in pharmaceutical governance in the region.