India’s drug regulator, CDSCO, has rolled out a real-time digital system on the ONDLS portal to monitor the supply and quality of high-risk solvents used in pharmaceutical manufacturing a move triggered by recent cough syrup contamination incidents.
Glimpse:
In response to fatal cases of syrup contamination, CDSCO has upgraded the Online National Drug Licensing System (ONDLS) to track high-risk solvents (like glycerin, propylene glycol, sorbitol, PEG, et al.). Manufacturers must now register, upload batch-level data and Certificates of Analysis (CoA), and submit vendor information giving regulators full visibility over production and distribution.
Amid growing alarm over cough syrups tainted with diethylene glycol (DEG), India’s Central Drugs Standard Control Organisation (CDSCO) has launched a digital monitoring system via the ONDLS portal to strengthen oversight of high-risk solvents used in pharmaceutical manufacturing
All state and union territory drug controllers have been instructed to ensure that manufacturers of pharmaceutical-grade solvents including glycerin, propylene glycol, maltitol, sorbitol, polyethylene glycol, and others obtain proper licensing via ONDLS. Existing licensees must register under the system’s “Old Licence Management” section and submit detailed records such as batch quantities, vendor information, and Certificates of Analysis (CoA).
Under the new mandate, no batch of these solvents can be released or distributed without proper registration, testing, and regulatory approval. The system enables real-time tracking of supply chains and quality assurance, closing loopholes in transparency and accountability across manufacturing and distribution.
This measure is part of CDSCO’s response to the shock caused by multiple child deaths in Madhya Pradesh, where contaminated cough syrup (notably “Coldrif”) was found to contain DEG far above permissible limits. The digital monitoring push reflects an urgency to prevent further pharmaceutical safety failures.
“We must ensure that the building blocks of medicines are beyond reproach this digital system gives us the eyes to detect, trace and prevent contamination.”
By
HB Team
