The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System through its Online National Drug Licensing System (ONDLS) portal to strengthen oversight of high-risk pharmaceutical solvents. This initiative, communicated via a letter dated October 22, 2025, responds to recent safety concerns, including the detection of Diethylene Glycol (DEG) in cough syrups, which posed major public health risks.
Following a high-level meeting chaired by the Union Health Secretary on October 5, 2025, the CDSCO has authorized strict compliance for solvent manufacturers. All manufacturers must now obtain or register their licenses on the ONDLS portal, with existing licensees submitting their current data through the “Old Licence Management” section. Additionally, batch-wise details, including quantity produced, Certificate of Analysis (CoA), and buyer information, must be uploaded.
State and UT Drug Controllers are directed to ensure no high-risk solvent batch reaches the market without adherence to these requirements. The updated ONDLS portal is fully operational to secure the pharmaceutical supply chain and protect product quality.