Medicines Advisory Committee calls for ban on high-risk solvents in children’s oral medicines: What it means

India’s top pharmaceuticals regulator has taken action to strengthen safety rules in response to a tragic wave of child deaths caused by contaminated cough syrup.

The Drugs Advisory Committee (DCC) recommended that the Central Drugs Standard Control Organization (CDSCO) prohibit the use of specific “high risk” solvents in pediatric oral liquid medicines.

The decision was approved during the 67th meeting of the DCC on November 17 in response to at least 22 deaths linked to contaminated syrup in Madhya Pradesh’s Chhindwara district.

The investigation into the deaths revealed that one syrup, Coldrif, was found to contain 48.6% of the deadly industrial ingredient diethylene glycol (DEG). Whereas, the acceptable limit of such solvents in medical syrups is barely 0.1%.

The DCC has recommended removing cough syrups from “Schedule K” exemption – a regulatory category that previously allowed syrups to be sold over-the-counter in some remote areas – meaning these medicines will only be sold with a doctor’s prescription.

Additionally, the Committee requested that CDSCO liaise with concerned parties and examine the feasibility of substituting safer alternatives for hazardous solvents such as propylene glycol (PG) and other related solvents.

This regulatory step comes after CDSCO took other measures to address the matter from October 2025. Manufacturers of pharmaceutical-grade solvents are required to register under the regulator’s digital monitoring system on the online National Drugs Licensing System (ONDLS) site, share vendor and distributor details and produce batch-wise certificates of analysis (CoA).

The central authority revamped the ONDLS portal to monitor the supply chain and quality of ten high-risk solvents like glycerin, propylene glycol and diethylene glycol stearate.

Further, States and Union Territories have been directed to ensure that no batch of solvents is allowed to enter the market without proper testing and documentation.

Additionally, as a follow-up to the recent fatalities, CDSCO collected 19 samples of oral syrups, antipyretic drugs, and antibiotics and initiated risk-based inspections at production facilities in six states.

In October, drug authorities reported two more syrups, Respifresh TR and Relife, for containing more DEG than allowed; However, these formulations were not linked to the deaths in Chhindwara.

Additionally, CDSCO has identified 112 drug samples, of which 52 were evaluated in central laboratories and 60 were evaluated in state laboratories, which were not of standard quality (NSQ). These include multivitamin supplements and popular drug formulations like pantoprazole and paracetamol.

According to Business Standard, the list also includes diclofenac-based painkillers and several batches of Telmisartan tablets, which are recommended for patients with hypertension or high blood pressure.