Doctor’s prescription now mandatory for cough syrups and other medicinal syrups; Centre tightens drug sale rules

PTC Web Desk: The Central Government has tightened regulations governing the sale of medicinal syrups, including cough syrups, by making a doctor's prescription mandatory for their purchase from pharmacies across the country.

The change comes through the Drugs (Fifth Amendment) Rules, 2026, notified on June 9, and is aimed at strengthening oversight of liquid medicines following recent safety concerns linked to contaminated cough syrups.

Under the amendment, the government has removed the term "Syrups" from a category of medicines listed under Schedule K of the Drugs Rules, 1945. As a result, these medicines will no longer be available over the counter and can only be sold against a valid prescription issued by a registered medical practitioner.

The decision follows incidents in Madhya Pradesh and Rajasthan where contaminated cough syrups were allegedly linked to the deaths of several children, prompting renewed scrutiny of the manufacture, distribution and sale of syrup-based medicines.

According to the notification issued by the Department of Health and Family Welfare, the amendment has been introduced under the powers granted by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940. The new rules came into effect immediately upon their publication in the Official Gazette.

The government had first proposed the amendment through draft rules released on December 30, 2025, and invited objections and suggestions from stakeholders and the public. After reviewing the feedback received during the consultation period, the Centre finalised the amendment.

With the revised rules now in force, pharmacies will be required to ensure that medicinal syrups, including cough formulations, are dispensed only after verifying a valid prescription.