Overview
- A DCGI directive dated October 22 made a Digital Monitoring System live on the ONDLS portal to oversee solvent production, movement, and quality in real time.
- All pharmaceutical‑grade solvent manufacturers must obtain licences via ONDLS and upload batch‑level data including quantity, certificate of analysis, and buyer or vendor details.
- CDSCO identified ten high‑risk solvents for targeted oversight, including glycerin, propylene glycol, sorbitol, maltitol, polyethylene glycol (molecular weight under 1000), and ethyl alcohol.
- State and UT drug controllers were told to block market release of any batch not verified on the portal, step up testing and inspections, and conduct manufacturer sensitisation.
- The action follows child deaths tied to DEG‑contaminated syrups and a WHO alert on risks from untracked distribution, with reports indicating Sresan Pharmaceuticals’ licence was revoked and its unit ordered shut.