CDSCO Launches Digital Monitoring System on ONDLS for High-Risk Solvents

The move follows recent reports of contaminated cough syrups containing diethylene glycol (DEG) above permissible limits, linked to the deaths of over 20 children in Madhya Pradesh.

The Central Drugs Standard Control Organization (CDSCO) has introduced a Digital Monitoring System on the Online National Drugs Licensing System (ONDLS) portal to track the supply chain and quality of high-risk pharmaceutical solvents. 

The move follows recent reports of contaminated cough syrups containing diethylene glycol (DEG) above permissible limits, linked to the deaths of over 20 children in Madhya Pradesh.

Following high-level meetings on October 5, 2025, the CDSCO determined the need for enhanced monitoring of approximately 10 high-risk solvents, including propylene glycol. The ONDLS portal has been upgraded and is now live to facilitate this oversight.

Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi, in a communication to drug controllers across states and union territories, stated, "You are requested to direct all the manufacturers of pharma-grade solvents to obtain a manufacturing license through ONDLS portal."

He added, "In case the manufacturer already holds the manufacturing license, he must register on the ONDLS portal and submit the data through 'Old License Management' under ONDLS."

Solvent manufacturers are also required to upload batch-specific details on the portal, including quantity, Certificate of Analysis (CoA), and information on vendors supplied. The DCGI further directed state and UT regulators to ensure that no batch enters the market without adherence to these requirements.

The list of high-risk solvents includes glycerin, propylene glycol, maltitol and maltitol solution; sorbitol and sorbitol solution; hydrogenated starch hydrolysate; polyethylene glycol (MW less than 1000); diethylene glycol stearates; polyethylene glycol monomethyl ether (certain low MWs); polysorbates 20/40/60/80; polyoxyl 15 hydroxystearate; polyoxyl 20 cetostearyl ether; polyoxyl 8 stearate; octoxynol 9; nonoxynol 9; and ethyl alcohol.

The CDSCO reiterated that the ONDLS portal serves as a single-window platform for online processing of manufacturing and sales licenses, including Blood Banks and certifications like COPP, GMP, WHO-GMP, and Market Standing certificates. Following the cough syrup incident, the CDSCO has urged states and UTs to implement testing before manufacture and market release, including enhanced inspections and manufacturer sensitization via circulars.

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