India Moves to Ban High-Risk Solvents in Children’s Syrups, Shift Cough Syrups to Prescription-Only

Regulators have begun supplier registration, batch testing, consultations on safer excipients following fatal DEG contamination.

Overview

At its Nov. 17 meeting, the Drugs Consultative Committee urged the CDSCO to prohibit specified high-risk solvents in paediatric oral liquid medicines.
The panel supported removing cough syrups from Schedule K, which would end over-the-counter sales in exempted areas by requiring prescriptions.
CDSCO ordered solvent‑manufacturer registration on the ONDLS portal, batch-wise certificates of analysis, mandatory DEG/EG testing for inputs and finished syrups, plus targeted sampling and inspections.
Investigators reported Coldrif contained 48.6% diethylene glycol in one sample, while Respifresh TR and ReLife showed elevated levels and were recalled with production halted.
Indian Pharmacopoeia updates have been fast‑tracked to embed DEG/EG testing norms, with stakeholder consultations underway to review formulations using propylene glycol and other high‑risk solvents.