Centre amends drug rules; prescription now mandatory for cough syrups

In a significant move aimed at strengthening the regulation of medicine sales, the Union Ministry of Health and Family Welfare has made it mandatory for consumers to present a doctor's prescription when purchasing syrup-based medicines, including cough syrups.

Implementation under Drugs (Fifth Amendment) Rules, 2026

The decision comes into effect following the notification of the Drugs (Fifth Amendment) Rules, 2026, which were published in the Official Gazette on June 9, 2026.

"In exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:- (1) These rules may be called the Drugs (Fifth Amendment) Rules, 2026. (2) They shall come into force on the date of their publication in the Official Gazette," the notification read.

Syrups no longer available as OTC medicines

Under the amended rules, syrup medicines will no longer be available over the counter (OTC), meaning pharmacies cannot sell them without a valid prescription from a registered medical practitioner.

Changes to Drugs Rules, 1945 and Schedule K

The amendment modifies the Drugs Rules, 1945, by removing the word "Syrups" from item number (7) under serial number 13 of Schedule K. Schedule K contains categories of medicines that are exempt from certain provisions of the Drugs and Cosmetics Act, 1940, subject to specified conditions.

"In the Drugs Rules, 1945, in Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word "Syrups," shall be omitted," the ministry said in the official notification.

Stricter regulatory requirements for syrup medicines

With syrups no longer included in the exemption list, these medicines will now be subject to stricter regulatory requirements governing their sale and distribution.

According to the notification issued by the Ministry of Health and Family Welfare, the amendment was finalised after considering objections and suggestions received from stakeholders and the public. A draft of the proposed rules was first published on December 29, 2025, inviting comments for a period of 30 days.

The government stated that the rules were framed under the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, and were introduced after consultation with the Drugs Technical Advisory Board.

Objective of the drug rule amendment

The ministry said the move is intended to strengthen oversight of medicine usage and ensure that syrup-based formulations are dispensed under appropriate medical supervision.

Overview of the Drugs Rules, 1945

The Drugs Rules, 1945, framed under the Drugs and Cosmetics Act, regulate the manufacture, sale and distribution of medicines across India. The latest amendment marks a major change in the way syrup medicines are accessed by consumers, requiring prescriptions for their purchase from pharmacies nationwide.