Drug watchdog to track cough syrup ingredients digitally

After contaminated cough syrups led to death of children in Madhya Pradesh, India's drug regulator has launched a digital monitoring system to monitor the supply chain and quality of high-risk ingredients used in making these formulations.

In a letter to the states, Drug Controller General Dr Rajeev Singh Raghuvanshi said a high-level meeting was held with the Health Ministry early this month to review compliance with drug quality norms and promote the rational use of cough syrups, especially in children.

In a directive, he has said all manufacturers of pharmaceutical-grade solvents must obtain a manufacturing licence through the Online National Drugs Licensing System (ONDLS) portal. The Central Drugs Standard Control Organisation (CDSCO) has released a list of high-risk solvents which includes glycerin, propylene glycol, maltitol, sorbitol, hydrogenated starch hydrolysate, polyethylene glycol and ethyl alcohol, among others.

“As you are aware that there have been recent reports of contamination of cough syrups with diethylene glycol (DEG), raising serious safety concerns, a high-level meeting under the chairmanship of the Union Health Secretary was held with all states and UTs on 5.10.2025 to review compliance with drug quality norms and promote the rational use of cough syrups, especially in paediatric populations,” Raghuvanshi said.

On October 7, the CDSCO requested all states and UTs to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections. “It has been decided that a digital monitoring system on the ONDLS portal needs to be established for monitoring the supply chain as well as quality of the high-risk solvents, including propylene glycol. Accordingly, ONDLS portal has been upgraded and made live by this directorate for addressing the issue,” he said.

The states have to ensure that the manufacturer must register on the ONDLS portal. “Further, the solvent manufacturers shall also upload details on the portal regarding each batch manufactured with quantity, certificate of analysis (CoA), etc., and details of the vendors to whom the solvents are sold from time to time. You are also requested to ensure that no batch is available in the market without complying with the above direction,” he said.