Regulatory Measures on High-Risk Solvents in Cough Syrups

India's drug regulator is exploring methods to verify the quality of high-risk solvents, such as propylene glycol, which are used in making liquid oral formulations. This move follows incidents of contaminated cough syrups causing children's deaths.

Proposed Regulatory Changes

• The drug regulatory authority is considering halting the sale of cough syrups by non-licensed pharmacists in villages.
• Discussions are ongoing about whether the use of propylene glycol can be replaced in these formulations.
• An exemption for certain household remedies, including cough syrups, previously allowed for sale by unlicensed pharmacists in villages with populations under 1,000, may be revoked.

Addressing Toxic Contamination

• Concern over high-risk solvents like propylene glycol, due to possible contamination with diethylene glycol (DEG) and ethylene glycol (EG), has prompted a review by the Drugs Consultative Committee (DCC).
• Propylene glycol's role as a solvent, preservative, and stabilizer in oral liquid formulations, especially for pediatric use, is under scrutiny.

Government Initiatives

• The government is focusing on preventing toxic glycol contamination, which has been associated with several child deaths due to toxic cough syrups.
• A proposed digital monitoring system on the online national drugs licensing system (ONDLS) portal aims to track the supply chain of high-risk solvents.
• Solvent manufacturers are required to upload batch details, quantities, certificates of analysis, and vendor information on the ONDLS portal.