Following recent incidents of cough syrup contamination with Diethylene Glycol (DEG), the Central Drugs Standard Control Organisation (CDSCO) has intensified regulatory oversight to ensure the safety and traceability of high-risk pharmaceutical solvents. A meeting chaired by the Union Health Secretary on October 5, 2025, emphasised strict monitoring of solvent quality and enhanced coordination between State and UT drug controllers.

To strengthen quality surveillance and traceability, the CDSCO has launched a Digital Monitoring System on the ONDLS Portal for monitoring the manufacture and distribution of high-risk solvents used in pharmaceutical formulations.

Key directives issued:

• Mandatory registration: All manufacturers of pharma-grade solvents must obtain their manufacturing licence through the ONDLS portal.
• Existing licence holders: Those already holding a valid licence must register under the “Old Licence Management” module and update all relevant details.
• Batch data submission: Manufacturers must upload details of each batch produced — including quantity, Certificate of Analysis (CoA), and vendor information — on the ONDLS portal.
• Compliance enforcement: State and UT Drug Controllers must ensure no solvent batch is released or available in the market without compliance with this directive.

The digital monitoring will cover the following high-risk solvents:
Glycerin, Propylene Glycol, Maltitol (and Maltitol Solution), Sorbitol (and Sorbitol Solution), Hydrogenated Starch Hydrolysate, Polyethylene Glycol (MW <1000), Diethylene Glycol Stearates, Polyethylene Glycol Monomethyl Ether (certain low MWs), Polysorbates (20/40/60/80), Polyoxyl compounds, Octoxynol 9, Nonoxynol 9, and Ethyl Alcohol.