The Central Drugs Standard Control Organization (CDSCO) unveiled a range of digital initiatives designed to transform pharmaceutical regulation in India. Announced at the iPHEX 2024 event, these advancements aim to boost transparency, enhance efficiency, and uphold the highest standards of safety and quality in the pharmaceutical industry, according to Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India (DCGI).
The three-day iPHEX 2024 event began on August 28, 2024, at the IEML Knowledge Park-II in Greater Noida. The premier event was a landmark occasion, offering a comprehensive platform for showcasing India’s pharmaceutical sector to a global audience. Organized by Pharmexcil, iPHEX 2024 is set to be a center of innovation, collaboration, and industry insights.
Dr. Raghuvanshi highlighted several key digital initiatives by CDSCO, starting with the National Single Window System (NSWS). This system is designed to consolidate regulatory approvals into a single, unified platform, reducing the need for multiple interfaces and streamlining processes for the industry. Currently, the NSWS is partially operational for medical devices and clinical trials, with plans for a phased expansion to other types of licenses.
Another significant development is the Online National Drug License System (ONDLS), also known as the “One Nation-One Drug Licensing System.” This initiative provides a centralized digital portal managed by CDSCO for uniform drug licensing across all states and union territories. It aims to standardize licensing requirements and processes, maintain a comprehensive license database, and enable quick verification to prevent discrepancies.
The introduction of the Track and Trace System will enhance the traceability of active pharmaceutical ingredients (APIs) and top formulations. This system will employ QR codes or barcodes for all APIs imported or produced in India, starting with the top 300 brands of formulations. Future phases will extend this system to all remaining formulations, vaccines, and narcotic drugs.
To expedite decision-making, CDSCO has also implemented streamlined Subject Expert Committee (SEC) meetings. This new format allows for more efficient and inclusive applicant presentations, aims for faster disposals, and includes a two-tier appeal mechanism for addressing grievances.
The Doorstep Delivery initiative will enable the direct sale and delivery of prescription drugs to consumers’ homes through registered emails, enhancing convenience while maintaining regulatory oversight. Additionally, the SUGAM portal integrates all import-related processes, clinical trials, and approvals for human and veterinary drugs, cosmetics, medical devices, and ethics committees. This comprehensive platform supports all facets of pharmaceutical regulation, ensuring compliance and ease of access to regulatory services.
As reported by pharmabiz.com, the initiatives are in line with the Government of India’s Digital India mission, which focuses on empowering stakeholders with more streamlined, transparent, and efficient regulatory systems. Through these digital advancements, CDSCO aims to solidify India’s position as a global leader in the pharmaceutical sector, with a continued emphasis on quality and safety.