The system will monitor the manufacture, quality, and distribution of high-risk solvents, including Propylene Glycol, Glycerin, and Sorbitol, which have been implicated in past contamination incidents.
The directive, issued under file number F. No. IT/ONDLS/MFG/Exp/2025/003 and dated 22.10.2025, has been sent by the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, to all State and Union Territory Drug Controllers for immediate implementation and compliance.
The move follows a series of safety concerns after incidents of DEG contamination in cough syrups, which have raised serious public health alarms globally and domestically
To address these concerns, a high-level meeting chaired by the Union Health Secretary was held on October 5, 2025, with all State and UT Drug Controllers to review compliance with drug quality norms and promote the rational use of cough syrups, particularly in paediatric populations.
Subsequently, the CDSCO, through its earlier letter dated 07.10.2025, had already directed all States and UTs to take proactive measures—such as ensuring testing of raw materials before manufacture and release, enhanced inspection monitoring, and sensitisation of manufacturers through circulars—to prevent contamination incidents.
Building on these efforts, the Directorate has now decided to operationalize a Digital Monitoring System via the ONDLS portal to track the supply chain and quality parameters of identified high-risk solvents listed in Annexure-1, with Propylene Glycol being a key solvent under scrutiny.
The ONDLS portal has been upgraded and made live for this specific purpose.
Under this initiative, All State/ UT Drug Controllers are told, "You are requested to direct all the manufacturers of pharma grade solvents to obtain manufacturing licence through ONDLS portal. In case the manufacturer already holds the manufacturing licence, he must register on the ONDLS portal and submit the data through "Old License Management" under ONDLS."
Further, it was stated, "The solvent manufacturers shall also upload details on the ONDLS portal regarding each batch manufactured with quantity, CoA, etc. and details of the vendors to whom the solvents are sold from time to time."
The CDSCO has categorically instructed that no batch of solvent shall be available in the market unless the manufacturer fully complies with these new digital monitoring requirements. State and UT Drug Controllers have been directed to enforce this mandate rigorously.
Furthermore, the CDSCO stated that in case of any difficulties, CDAC may be contacted at uttamkumar@cdac.in or ondlssupportnoida@cdac.in for any assistance.
Annexure- 1
List of 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 |
10. | Ethyl alcohol |
To view the official notice, click the link below:
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