Last Updated on September 30, 2024 by The Health Master
CDSCO
In the realm of pharmaceutical regulatory procedures, the Central Drugs Standard Control Organisation (CDSCO) has embarked on a significant digital transformation.
This initiative involves transitioning the submission of Period Safety Update Reports (PSUR) related to the marketing authorization of new drugs and others to an online system, marking a departure from the conventional offline mode.
The CDSCO has communicated that this transition will be effective from March 11.
Embracing Digital Evolution
The drug regulator, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), affirmed the functionality of the online system through the Sugam portal for submitting PSURs.
All applicants are now mandated to utilize this online portal, with offline submissions in hard copy or any other mode becoming obsolete from March 11, 2024.
A Systematic Approach
The move aligns with the broader strategy of the CDSCO to shift various application and approval processes to an online mode, reflecting the organization’s commitment to implementing an efficient e-governance mechanism.
Milestones in Digital Adoption
This shift follows the CDSCO’s directive last November, urging stakeholders to submit applications for Post Approval Changes (PACs) through the Sugam Portal for human vaccines and antisera, discontinuing the offline submission process from December 1, 2023.
Earlier in 2023, the CDSCO transitioned the submission procedure for test licenses for veterinary vaccines and drugs to an online format.
National Single Window System (NSWS) Portal
In a groundbreaking move, the CDSCO launched the National Single Window System (NSWS) portal on January 1, 2024.
This initiative, designed to enhance the ease of doing business in the medical devices industry, encompasses three initial activities.
The NSWS, developed by Invest India in collaboration with Tata Consultancy Service (TCS), serves as a one-stop-shop for all necessary approvals.
Expansion of NSWS Activities
Initially focusing on three activities under the Medical Devices Rules, 2017, the NSWS portal expanded its repertoire in January 2024.
Now, it includes five additional forms, ranging from applications for the manufacture of new drugs to the import of medical devices for clinical investigations.
Digital Drugs Regulatory System (DDRS)
Looking ahead, the CDSCO has initiated efforts to establish a Digital Drugs Regulatory System (DDRS).
Envisaged as a unified digital ecosystem with a single window, single sign-on, and a unified portal, DDRS aims to build trust, transparency, and accountability in drug regulation.
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