The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System on the Online National Drugs Licensing System (ONDLS) portal to closely track the supply chain and quality of high-risk pharmaceutical solvents. State drug controllers have been directed to ensure that all manufacturers of pharma-grade solvents obtain manufacturing licences through the upgraded digital platform.
This initiative follows recent reports of contaminated cough syrups containing diethylene glycol (DEG) beyond permissible limits, which led to the deaths of over 20 children in Madhya Pradesh. In response, the Union Health Ministry and CDSCO held high-level meetings on October 5, 2025, after which the decision was made to strengthen oversight of solvent quality and distribution.
The newly established monitoring system on the ONDLS portal will help track approximately 10 high-risk solvents, including propylene glycol, a key ingredient in many pharmaceutical formulations. The portal has been enhanced and is now fully operational to support this initiative.
The Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, has instructed all state and Union Territory (UT) drug controllers to ensure that manufacturers of pharma-grade solvents obtain or register their manufacturing licences via the ONDLS portal. Existing licence holders are required to register under the “Old Licence Management” module and upload detailed information for every batch produced, including quantity, certificate of analysis (CoA), and vendor details. Regulators have also been asked to ensure that no solvent batch is marketed without complying with these digital reporting requirements.
The list of high-risk solvents identified by the CDSCO includes:
Glycerin
Propylene glycol
Maltitol and maltitol solution
Sorbitol and sorbitol solution
Hydrogenated starch hydrolysate
Polyethylene glycol (molecular weight below 1000)
Diethylene glycol stearates
Polyethylene glycol monomethyl ether (low molecular weights)
Polysorbates (20/40/60/80), polyoxyl 15 hydroxystearate, polyoxyl 20 cetostearyl ether, polyoxyl 8 stearate, octoxynol 9, nonoxynol 9
Ethyl alcohol
The ONDLS portal, designed as a single-window platform for licensing, certification, and post-approval processes, supports applications for manufacturing and sales licences, blood bank approvals, and certificates such as COPP, GMP, WHO-GMP, and Market Standing Certificates.
Following the recent incidents, CDSCO has also advised states and UTs to strengthen quality assurance mechanisms by ensuring batch testing before market release, conducting regular inspections, and issuing advisories to sensitise manufacturers about compliance and safety standards.
This digital initiative marks a significant step towards enhancing transparency, accountability, and traceability in India’s pharmaceutical manufacturing ecosystem.
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