To address recent concerns over contamination in cough syrups, the CDSCO has launched a Digital Monitoring System on the ONDLS portal. This system mandates solvent manufacturers to register and upload batch-wise data, including CoA and vendor details. The initiative aims to ensure transparency, traceability, and quality control of high-risk solvents like Propylene Glycol and Glycerin used in pharmaceutical manufacturing.
In response to alarming reports of DEG contamination in cough syrups, the Central Drugs Standard Control Organisation (CDSCO) has implemented a Digital Monitoring System through the ONDLS portal.
This initiative, following a high-level meeting chaired by the Union Health Secretary, is designed to enhance oversight of high-risk pharmaceutical solvents such as Propylene Glycol, Glycerin, and Sorbitol.
All manufacturers of pharma-grade solvents are now required to obtain or update their manufacturing licenses via the ONDLS portal. Additionally, they must upload detailed information for each batch produced, including quantity, Certificate of Analysis (CoA), and vendor distribution data.
This digital system ensures real-time monitoring of the supply chain and enforces compliance with stringent quality norms.The move is a proactive step toward safeguarding public health, especially for vulnerable populations like children, by preventing the circulation of contaminated or substandard pharmaceutical ingredients.
States and UTs have been directed to ensure strict adherence, with technical support available through CDAC.