Cough syrup deaths: CDSCO launches digital tracker for high-risk solvents
All the state and Union Territory drug controllers have been told to ensure that manufacturers of pharmaceutical-grade solvents
 "Cough syrup deaths: CDSCO launches digital tracker for high-risk solvents")
India’s drugs watchdog has announced a new system to monitor the supply and quality of high-risk solvents in the cough syrups on the heels of the death of at least 24 children due to consumption of syrups contaminated with toxic diethylene glycol (DEG).
The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System on the ONDLS portal
to track the supply chain and quality of solvents used in pharmaceutical manufacturing.
All the state and Union Territory drug controllers have been told to ensure that manufacturers of pharmaceutical-grade solvents, including propylene glycol, glycerin, maltitol, sorbitol, polyethylene glycol, and others, obtain a manufacturing licence through the ONDLS portal.
Manufacturers holding existing licences must register on the portal and provide batch-level details, certificates of analysis (CoA), and vendor information.
The portal will allow regulators to monitor the production, sale, and distribution of high-risk solvents in real-time.
States and UTs have been asked to enforce these measures rigorously, including testing solvents before manufacture, monitoring compliance during inspections, and sensitising manufacturers about safe production practices. CDSCO has also provided technical support contacts for any difficulties in using the portal.
The list of high-risk solvents includes glycerin, propylene glycol, maltitol and its solution, sorbitol and its solution, hydrogenated starch hydrolysate, polyethylene glycol (MW <1000), diethylene glycol stearates, certain low-molecular-weight polyethylene glycol monomethyl ethers, polysorbates, and ethyl alcohol.
At least 24 children have died after consuming cough syrup contaminated with DEG in Chhindwara district of Madhya Pradesh.
The deaths have been linked to Coldrif syrup, manufactured by Sresan Pharmaceuticals in Tamil Nadu. The company’s manufacturing licence has been revoked and it has been ordered to permanently shut down.