Last Updated on December 9, 2025 by The Health Master
ONDLS Portal
Download the circular, link is given below: India’s Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System on the Online National Drug Licensing System (ONDLS Portal) with immediate effect concerning all manufacturers of high-quality solvents used in pharmaceuticals, requiring batch-to-batch entry and tracking in a new aggressive regulatory response to recent reports of fatal adulteration.
Why the Quality Testing Mandate?
Following news reports of the dastardly utilization of Diethylene Glycol (DEG) in cough syrups, the Union Health Secretary’s October 2025 review of drug quality norms found deficiencies that prompted immediate action.
This was done in light of tragic deaths due to adulterated cough syrup, especially in children.
Until now, allowing for the adequate monitoring of such raw materials has been challenging, as their tracking from product to processing plant to medicine has been complex, often using manual systems at best to create tangibility that has been altered.
Now, the hope with this system is that no drop of these high-risk solvents will go unaccounted for and thus be tested and verified before entering the marketplace for medicine production.
How the ONDLS Portal System Works
As per this digital monitoring system, manufacturers must now use the ONDLS portal that was already set up for other purposes to create a chain of custody from beginning to end.
Transparency falls on the shoulders of the solvent manufacturers.
Digital Compliance Checklist for Solvent Manufacturers
1. All manufacturers of pharma-grade solvents must obtain a manufacturing license and register on the ONDLS portal. Previous licensed manufacturers must also register and submit their old license data through the Old Licence Management section.
2. Every batch manufactured is required to provide the following information on the ONDLS portal:
- Total Quantity
- CoA
- Vendor Details (i.e. pharmaceutical companies that purchased solvents)
3. “No batch is available in the market without complying with the above direction,” according to CDSCO.
Where it was once easier to obtain ingredients, now they are digitally registered.
The CDSCO circular identifies the following eight categories of solvents as high risk and under digital watch, meaning it effectively creates a pharmaceutical supply chain digitization of these vulnerable materials.
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)
- Polysorbate 20/40/60/80, Polyoxyl 15 Hydroxystearate, Polyoxyl 20 Cetostearyl Ether, Polyoxyl 8 Stearate, Octoxynol 9, and Nonoxynol 9
- Ethyl Alcohol
Q1: Why the Digital Monitoring System Now for high risk solvents?
Because of recent, globally publicized situations regarding Diethylene Glycol (DEG) in cough syrups, there needed to be end-to-end monitoring in terms of transparency so if there are high-risk solvents, they cannot be substandard materials that endanger public safety.
Q2: Which Manufacturers Must Comply?
All pharma-grade solvent manufacturers moving forward and those registered prior must comply via registration on the ONDLS portal for additional information per high-risk solvents manufactured.
Q3: What Data Has to Be Uploaded?
The total quantity of each batch manufactured, the CoA in its entirety, and the details of all vendors to whom this was sold.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
USFDA inspection with positive VAI to Dr Reddy’s Formulations facility
Drug recall: Glenmark recalls 26,928 packs of oral contraceptives
New Drugs, Medical Devices and Cosmetics Act soon
Govt to amend MDR 2017: New Qualifications for Inspectors and Analysts
Drug recall: Zydus recalls 1512 bottles of Hepatitis B Drug
Govt rolls out incentive scheme for Pharma and MedTech sector
USFDA approval granted for Paroxetine Extended-Release tablets: Alembic
Drug recall: 5 Indian Companies recall drugs over quality issues
