Cough Syrups To Be Available Only With Doctor’s Prescription

New Delhi: Due to drug quality and patient safety concerns, the Union Health Ministry has changed rules banning the sale of syrups, including cough syrups, without a doctor’s prescription. Official sources said the move aims to bring syrup-based formulations, including cough syrups, under tighter regulatory control.

The change was announced through the Drugs (Fifth Amendment) Rules, 2026 published in the official gazette. The change entered into force immediately from the date of its publication.

According to the notification issued by the Ministry of Health and Family Welfare, the word “syrups” has been deleted from clause 7 of the “Drug Class” column of Schedule K of the Drug Rules, 1945.

Schedule K specifies categories of medicines that are exempt from certain provisions relating to manufacture, sale and distribution under the Drugs and Cosmetics Act and Rules, subject to prescribed conditions.

The move follows a draft notification issued by the government in December last year, seeking objections and suggestions from stakeholders.

The ministry said that before finalizing the change, comments received from the public were taken into account after consulting with the Drug Technical Advisory Board (DTAB), the country’s highest legal body on drug-related technical matters.

The decision comes amid increased regulatory scrutiny of cough syrups and other liquid oral formulations following reports of child deaths due to contamination in many countries in recent years.

According to sources, the latest change is expected to increase traceability and regulatory oversight of syrup-based medicines by ensuring that manufacturers and sellers comply with stricter licensing and quality control requirements.