CDSCO Shifts PSUR Submission Online

This transition marks a significant step in streamlining regulatory submissions and embracing digitalization within the pharmaceutical sector.

To modernize regulatory procedures, the Central Drugs Standard Control Organisation (CDSCO) has shifted the submission process for Period Safety Update Reports (PSUR) concerning the marketing authorization of new drugs and others to an online system. 

This transition marks a significant step in streamlining regulatory submissions and embracing digitalization within the pharmaceutical sector.

Commenting on the necessity of this shift, Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), said, "All applicants submitting PSURs shall apply through an online portal as per checklist in the portal. The ability to submit applications offline in hard copy or any other mode will not be available for processing from March 11, 2024."

This move aligns with CDSCO's ongoing efforts to streamline various application and approval processes through online platforms. Last November, stakeholders were directed to submit applications for Post Approval Changes (PACs) regarding marketing authorization for human vaccines and antisera via the Sugam Portal's online system, discontinuing offline submissions from December 1, 2023.

In early 2023, CDSCO transitioned the procedure for submitting test license forms for veterinary vaccines and drugs to an online format, ceasing offline submissions in hard copy. This trend towards digitalization underscores CDSCO's commitment to enhancing efficiency and transparency in regulatory processes.

National Single Window System (NSWS) Portal Launch

In a bid to enhance regulatory efficiency further, CDSCO launched the National Single Window System (NSWS) portal on January 1, 2024. Developed by Invest India in collaboration with Tata Consultancy Service (TCS), NSWS aims to simplify the approval process for the medical devices industry by serving as a one-stop shop for all necessary approvals.

Initially focusing on activities under the Medical Devices Rules, 2017, NSWS offers applications for a Certificate of Registration of a notified body, a license to manufacture medical devices for various purposes, and a license to import medical devices for clinical investigations or testing.

Comprehensive Regulatory Guidelines for Drug Quality Surveillance

To bolster drug quality surveillance across India, CDSCO recently unveiled comprehensive regulatory guidelines for sampling drugs, cosmetics, and medical devices. These guidelines aim to standardize and streamline the sampling process while ensuring a centralized approach to maintaining data on product quality.

In line with these initiatives, the CDSCO has initiated plans to establish a Digital Drugs Regulatory System (DDRS) to serve as a unified digital ecosystem, simplifying regulatory activities for drugs, medical devices, cosmetics, and more.

The DDRS is expected to improve trust and confidence in the quality of healthcare products domestically and globally. To support this initiative, the CDSCO has invited Expressions of Interest (EoI) from Software Services Providers (SSPs) to facilitate the digital transformation of CDSCO, IPC, and NIB, with an expected duration of eight to ten years.

The system aims to be modular, accommodating various aspects of regulatory oversight, including end-to-end product management, stakeholder integration, real-time information capture, supply chain tracking, and monitoring of vigilance and enforcement activities.

By embracing digital initiatives, CDSCO aims to streamline regulatory procedures, facilitate ease of doing business, and ensure the safety and efficacy of healthcare products in the market.