Amid growing safety concerns over the unchecked use of syrup-based medicines, the Union Health Ministry has restricted their sale to valid prescriptions only, mandating that cough syrups and other medicinal syrups will be dispensed only through duly licensed pharmacies.
Issuing a gazette notification, the ministry communicated the omission of “Syrup” from the “Class of Drugs” listed under Schedule K of the Drugs Rules, 1945, through the Drugs (Fifth Amendment) Rules, 2026, notified in the Official Gazette on June 9.
With this omission, the sale of syrup-based medicines, including cough syrups, will require a valid prescription from a registered medical practitioner and “will be dispensed only through duly licensed pharmacies, in accordance with the provisions of the Drugs and Cosmetics Act, 1940,” the ministry said in a statement.
The move effectively ends the over-the-counter (OTC) sale of these syrups across India, as under the amendment, the word “Syrups” has been removed from item number (7) under serial number 13 of Schedule K of the Drugs Rules, 1945.
Under the new directive, chemists and pharmacies can sell syrup-based medicines only after seeing a valid prescription from a registered medical practitioner, which applies not only to cough syrups but to all medicinal syrups that were previously available without prescription requirements.
According to the health ministry, “the move is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” official sources said.
By making prescriptions mandatory for syrup medicines, the government aims to reduce misuse, improve patient safety, and encourage people to seek professional medical advice before taking medication.
The change follows concerns over the safety and quality of certain India-made cough syrups that were linked to deaths and health complications in some overseas markets, authorities say.
However, officials have clarified that this is not a blanket ban on all cough syrups, with the requirement for a prescription depending on the composition and regulatory classification of each formulation.
The Union Health and Family Welfare Ministry notified the amendment to bring syrup-based formulations, including cough syrups, under stricter regulatory oversight, with the sale and dispensing of cough syrups in smaller villages now required to take place only through duly licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940 and the Rules framed under it.
