The recent deaths of at least 25 children in India from contaminated cough syrup has prompted the government to set up a digital monitoring system to keep a check on the supply chain and high-risk solvents. Through an advisory issued to all state and Union Territory drug controllers, Central Drugs Standard Control Organisation (CDSCO) said that it has upgraded the Online National Drugs Licensing System (ONDLS) portal through which manufacturers of pharma grade solvents can obtain manufacturing licence.
“In case the manufacturer already holds the manufacturing licence, he must register on the ONDLS portal and submit the data through “Old Licence Management” under ONDLS,” the advisory said. The ten high-risk solvents highlighted by the CDSCO include glycerin, propylene glycol, diethylene glycol stearates, ethyl alcohol and others.
Further, the solvent manufacturers will have to upload details on the ONDLS portal regarding each batch manufactured with quantity, certificate of analysis, and details of the vendors to whom the solvents are sold.
Earlier, the central drug control department had asked state authorities to test the raw materials and finished formulations before they are released to the market. Following the deaths, the World Health Organization (WHO) issued a health advisory warning against the use and distribution of three cough syrups Coldrif, Respifresh TR and ReLife.