The DCGI chief said that a digital monitoring system needs to be created on the ONDLS portal to monitor the supply chain as well as the quality of high-risk solvents, including propylene glycol. Representative image. | Photo credit: Getty Images/iStockphoto
The Drugs Controller General of India (DCGI) has managed the digital monitoring of the Online National Drugs Licensing System (ONDLS) to track the supply chain of high-risk solvents.
The order, issued earlier this week, comes after serious safety concerns following the alleged deaths of more than 20 children under the age of five due to diethylene glycol (DEG) contamination of cough syrups in Madhya Pradesh recently. DEG is a toxic, colorless, odorless liquid with a sweet taste, often used as an industrial solvent.
ONDLS is a single window digital platform in India for processing drug and cosmetics related applications for manufacturing and sales licenses and various certificates. Developed by the Center for Development of Advanced Computing (CDAC) in collaboration with the Central Drugs Standard Control Organization (CDSCO), it aims to streamline and standardize the process across the country.
In his letter, DCGI chief Rajeev Singh Raghuvanshi noted, “It has been decided that a digital monitoring system needs to be created on the ONDLS portal to monitor the supply chain as well as the quality of high-risk solvents, including propylene glycol. Accordingly, the ONDLS portal has been updated and made operational by this directorate to address the issue.”
Also Read: CDSCO demands list of all cough syrup makers in India, launches joint audit
Earlier, all States/Union Territories were asked to review adherence to drug quality standards and promote rational use of cough syrups, especially in the pediatric population. Besides, they have been asked to take measures to ensure pre-production and batch testing through monitoring during inspections, sensitization of manufacturers through circulars, etc.
Dr. Raghuvanshi said that according to the latest order, all manufacturers of pharmaceutical grade solvents should obtain a manufacturing license through the ONDLS portal. The letter stated that in case the manufacturer already owns a manufacturing license, he must register on the ONDLS portal and submit the data through Old License Management under ONDLS.
Further, the solvent manufacturers should upload the details regarding each batch produced with quantity etc. and the details of the dealers to whom the solvents are sold from time to time on the ONDLS portal.
“You are also requested to ensure that no batch is made available in the market without complying with the above guidelines,” the DCGI directed.
Published – 23 Oct 2025 21:25 IST
