As Health Ministry issues diktat on cough syrups, questions arise over OTC enforcement

The Indian Ministry of Health and Family Welfare has mandated prescription-only sales for cough syrups, including syrup formulations, in a bid to tighten controls over the use of these medicines. The new rules, issued on June 16, 2026, will see cough lozenges, pills and tablets still available over the counter (OTC), but syrups requiring a prescription.

This move comes in response to concerns over overdoses, incorrect dosing and the indiscriminate use of cough-and-cold preparations. Dr. Sivaranjani Santosh, a paediatrician from Hyderabad, welcomed the decision, highlighting the need for tighter regulation due to the potential complications posed by ingredients like terbutaline, levosalbutamol, salbutamol, chlorpheniramine maleate and phenylephrine.

However, doubts persist over the effectiveness of the new regulations. Pharmacists argue that many patients expect immediate relief and question whether a blanket prescription requirement will work in the long run. Counterfeit, adulterated and unbranded medicines also pose a significant challenge, making it difficult to differentiate between genuine and fake products.

Although codeine-containing cough syrups have largely been dispensed under prescriptions, concerns remain about the longevity of such restrictions. The Telangana Chemists and Druggists Association swiftly informed pharmacies about the new rules, but implementation is expected to vary across regions due to the difficulty in enforcing rules in smaller localities and towns.