New Delhi: The Union Ministry of Health and Family Welfare has issued a notification placing all syrup formulations, including cough syrups, under prescription-only regulation, thereby prohibiting their over-the-counter sale without a valid prescription from a registered medical practitioner.
Union Ministry of Health and Family Welfare Amends Drugs Rules, 1945; Exemption for Sale of Cough Syrups in Small Villages Withdrawn
Key Amendment to Drugs Rules to Enhance Regulatory Control Over Cough Syrups notifiedhttps://t.co/eHlqszzcoK
— Ministry of Health (@MoHFW_INDIA) June 16, 2026
The notification, which came into effect on June 16, requires consumers to present a valid prescription from a registered medical practitioner in order to purchase any syrup formulation from pharmacies.
The move follows the notification of the Drugs (Fifth Amendment) Rules, 2026, issued by the Department of Health and Family Welfare on June 9. The rules state that they “shall come into force on the date of their publication in the Official Gazette,” according to the notification.
Under the amendment, the Centre has omitted the word “Syrups” from Schedule K of the Drugs Rules, 1945. Schedule K specifies categories of drugs that are exempt from certain provisions governing their sale and distribution under defined conditions.
“In the Drugs Rules, 1945, in Schedule K, under the column titled ‘Class of Drugs’, against serial number 13, item number (7), the word ‘Syrups’ shall be omitted,” the notification stated.
The government stated that the amendment was notified after a draft of the proposed rules was published in December 2025, and that objections and suggestions received from the public were duly considered. The notification further stated that the rules were framed by the Central Government “after consultation with the Drugs Technical Advisory Board,” in exercise of powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
