Why in the news?
- The Drugs Controller General of India (DCGI) has mandated digital surveillance through the Online National Drugs Licensing System (ONDLS) to monitor and track the supply chain of high-risk solvents.
Online National Drugs Licensing System (ONDLS)
- What is it?: The Online National Drugs Licensing System (ONDLS) is a digital, single-window platform for processing drug-related licenses and monitoring high-risk pharmaceutical ingredients.
- Developed by: It is developed by the Centre for Development of Advanced Computing (CDAC) in collaboration with the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, and State/UT Drugs Regulatory Authorities under the Ministry of Health and Family Welfare.
- Implementation: Supervised by the CDSCO under the Ministry of Health and Family Welfare.
- Objectives:
- To ensure transparency, uniformity, and accountability in drug licensing across States and Union Territories.
- To provide real-time digital monitoring of manufacturing activities, especially for critical ingredients.
- To prevent adulteration and contamination of medicines, improving patient safety and pharmaceutical quality.
- Key Features:
- Single-Window Licensing Platform: For applications related to manufacturing and sales licenses, blood banks, and other certifications (COPP, GMP, WHO-GMP, Market Standing Certificates).
- Real-time Tracking of Solvents: Monitors solvents like glycerin, propylene glycol, sorbitol, maltitol, ethyl alcohol, and hydrogenated starch hydrolysate for safety compliance.
- Batch-wise Entry System: Mandates manufacturers to log details for every batch, including quantity, certificate of analysis (CoA), and vendor data.
- Integration with State Drug Authorities: Ensures uniform document submission and decision-making across States and UTs.
- Post-approval Change Management: Allows updates to licenses in compliance with regulatory standards without manual interference.
- Significance:
- Promotes Patient Safety: Prevents adulterated raw material use in pharmaceuticals.
- Enhances Traceability: Enables digital monitoring of every stage in drug manufacturing.
- Improves Regulatory Uniformity: Reduces inter-state licensing discrepancies.
- Supports E-Governance: Advances digitization of India’s public health regulation system.