The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System on its Online National Drug Licensing System (ONDLS) portal to enhance surveillance over the supply chain and quality of high-risk pharmaceutical solvents.
This critical action, announced in a letter dated October 22, 2025, is in direct response to recent contamination reports, notably Diethylene Glycol (DEG) found in cough syrups, which raised serious safety concerns across the country. The move follows a high-level meeting chaired by the Union Health Secretary on October 5, 2025, concerning drug quality compliance.
Mandatory Compliance for Solvent Manufacturers
The CDSCO has instructed all State and UT Drug Controllers to ensure that manufacturers of pharma grade solvents immediately comply with the new system:
- Mandatory Licensing and Registration: All manufacturers of pharma grade solvents must obtain their manufacturing license through the ONDLS portal.
- Existing Licensees: Manufacturers already holding a valid manufacturing license must register on the ONDLS portal and submit their existing data through the “Old Licence Management” section of the portal.
- Batch-wise Data Upload: Solvent manufacturers are now required to upload detailed information on the ONDLS portal for each batch manufactured, including:
- Quantity produced.
- Certificate of Analysis (CoA).
- Details of the vendors to whom the solvents are sold.
The CDSCO has also requested Drug Controllers to ensure that no batch of high-risk solvents is available in the market without complying with these new directions. The updated ONDLS portal is now live to address this urgent supply chain and quality issue.
For assistance, users may contact C-DAC at uttamkumar@cdac.in or ondlssupportnoida@cdac.in.