Amid growing concerns over drug safety, the Centre has tightened rules governing the sale of syrups, including cough formulations. Under the amended regulations, a doctor's prescription is now mandatory to purchase these medicines from pharmacies. The Union Health Ministry stated that the decision was taken in direct response to recent cases of contaminated cough syrups.
The Union Ministry of Health and Family Welfare has issued a notification on June 9, bringing into force the Drugs (Fifth Amendment) Rules, 2026.
The recent amendment removes the word 'Syrups' from a category of medicines in the section Schedule K. of the Drug Rules. With the recent move, the over-the-counter sale of syrups is not possible from here on.
According to the notification, the Centre exercised powers under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940, to amend the Drugs Rules, 1945. The notification was issued by Harsh Mangla, Joint Secretary, Department of Health and Family Welfare. With the amendment now in force, pharmacies across the country will have to comply with the revised rules governing the sale of syrups and related formulations.
The regulatory change means syrups, including commonly used cough syrups, will no longer be available for purchase without a doctor's prescription.
According to the Health Ministry, the amendment follows a public consultation process that began with the publication of draft rules in December 2025. Objections and suggestions received from stakeholders were examined before the final rules were notified.
The move is expected to affect routine purchases of cough and other medicinal prescriptions issued by a registered medical practitioner.
What Schedule K covers
Schedule K of the Drugs Rules, 1945 outlines the specific categories of drugs that are exempt from certain provisions of Chapter IV of the Drugs and Cosmetics Act (which governs the manufacture, sale, and distribution of drugs).
These products, which include common items such as antiseptics, antacids and contraceptives, are allowed to be sold over-the-counter (OTC).
