New Delhi, June 16: In a move aimed at strengthening drug safety and quality standards, the Union Health Ministry has made it mandatory for syrups, including cough syrups, to be sold only on a doctor’s prescription.
Officials said the decision is intended to bring syrup-based medicines under stricter regulatory control and improve oversight of their manufacture and sale.
The change has been introduced through the Drugs (Fifth Amendment) Rules, 2026, which were notified in the official gazette and came into effect immediately after publication.
As per the notification issued by the Ministry of Health and Family Welfare, the term “syrups” has been removed from Item 7 under the “Class of Drugs” section in Schedule K of the Drugs Rules, 1945. Schedule K lists medicines that are exempt from certain provisions related to manufacturing, sale and distribution under the Drugs and Cosmetics Act, subject to specified conditions.
The amendment follows a draft proposal released by the government in December last year, inviting feedback and suggestions from stakeholders. The ministry said all comments received were examined before the final decision was taken in consultation with the Drugs Technical Advisory Board (DTAB), the country’s top statutory body on technical matters concerning medicines.
The decision comes amid heightened scrutiny of cough syrups and other liquid oral medicines in recent years after reports linked poor-quality formulations to serious health incidents in several countries.
According to official sources, the latest rules are expected to improve traceability and regulatory supervision of syrup-based medicines by ensuring stricter compliance with licensing norms and quality-control standards by manufacturers and sellers.
