CDSCO strengthens digital tracking of high-risk pharmaceutical solvents through ONDLS

The Central Drugs Standard Control Organisation (CDSCO), through a communication dated 27 October 2026, has directed State and UT Drug Controllers to ensure compliance with the Digital Monitoring System on the Online National Drugs Licensing System (ONDLS) portal for specified high-risk pharmaceutical-grade solvents. Manufacturers and relevant vendors/suppliers are required to register on the portal and upload batch-wise information, including quantities manufactured and supplied, Certificates of Analysis (CoAs), vendor details and onward distribution records. A system-generated No Objection Certificate (NOC) must be obtained before distribution of covered batches. The materials include glycerin, propylene glycol, sorbitol and other specified solvents and excipients. The measure strengthens end-to-end traceability of pharmaceutical-grade raw materials, particularly in light of concerns over contamination of cough syrups with diethylene glycol (DEG).