Centre considers prescription-only rule for cough syrups after children's deaths
What's the story
In light of recent incidents involving contaminated cough syrups, the central government is considering a major regulatory change. The proposed change could end over-the-counter access to these products and require a doctor's prescription. The proposal is currently with the Drugs Consultative Committee (DCC) and seeks to remove cough syrups from Schedule K, which allows certain low-risk medicinal products to be sold without a license.
Regulatory review
Proposal aims to delete cough syrup sale exemption
The agenda document for the DCC meeting states, "In view of the recent incidence due to contaminated cough syrup, it is proposed that the exemption provided for the sale of syrups for cough may be deleted." The document specifically mentions deliberations on "syrups" and does not include other cough-related products like lozenges or pills. Schedule K products are generally considered safe for routine use and include items such as aspirin, paracetamol tablets, analgesic balms, antacid preparations, etc.
Health risks
Contaminated cough syrups linked to child deaths
The proposal comes after several child deaths in Madhya Pradesh due to contaminated cough syrups with high levels of diethylene glycol. The World Health Organization (WHO) issued a medical alert after these incidents, warning that unregulated distribution through informal channels could pose health risks. The repeated contamination cases have raised concerns about regulatory gaps in overseeing liquid drug formulations.