CDSCO has directed all manufacturers and suppliers of pharmaceutical-grade high-risk solvents to register on the ONDLS portal and upload batch-wise manufacturing, quality, and distribution data. Distribution of any batch is prohibited unless the required information is uploaded and a system-generated NOC is obtained, ensuring supply chain transparency and product quality monitoring.
The Central Drugs Standard Control Organisation (CDSCO) has implemented a Digital Monitoring System (DMS) through the Online National Drug Licensing System (ONDLS) portal to strengthen oversight of pharmaceutical-grade high-risk solvents and excipients such as glycerine, propylene glycol, and sorbitol.
The initiative was introduced following concerns regarding contamination incidents involving pharmaceutical products. Under this system, manufacturers and suppliers are required to register on the ONDLS portal and upload batch-wise details including manufacturing quantities, Certificates of Analysis (CoA), vendor credentials, quantities supplied, and complete distribution trails.
The system aims to ensure traceability and maintain supply chain integrity. CDSCO has further mandated that no batch of pharmaceutical-grade high-risk solvent may be distributed unless the required details are uploaded to the DMS and a system-generated No Objection Certificate (NOC) is obtained. State and UT Drug Controllers have been instructed to ensure strict compliance.