The Union Ministry of Health and Family Welfare has changed the law regarding the sale of cough syrup. Now, you would not be able to buy any cough syrup without a doctor’s prescription. The ministry has notified an amendment to the Drugs Rules, 1945, via Gazette Notification GSR 927(E) dated December 29, 2025.
Published in the Gazette of India (Extraordinary)—Part II, Section 3, Sub-section (i)—on December 30, 2025, this notification removes the word “Syrup” from the “Class of Drugs” column under Entry 7, Serial Number 13 of Schedule K.
Lozenges and tablets can be purchased without a doctor’s prescription. Schedule K of the Drugs Rules, 1945, grants exemptions to specific categories of drugs from certain provisions of the Drugs and Cosmetics Act, 1940, and the rules framed thereunder. Prior to this amendment, Entry 13 of Schedule K permitted the sale of cough medicines in villages with a population of less than 1,000 without requiring compliance with certain provisions regarding retail sale licenses.
With the removal of the word “Syrup” from the said entry, this exemption will no longer apply to cough medicine syrups. Consequently, the sale and distribution of cough medicine syrups in small villages must now be conducted exclusively through pharmacies duly licensed under the Drugs and Cosmetics Act, 1940, and the rules framed thereunder.
This amendment has been introduced to strengthen regulatory oversight of the manufacturing process for syrups and to align the exemption framework with contemporary public health and safety requirements. It is expected that this measure will promote the responsible distribution and sale of cough medicines while ensuring better compliance with regulatory standards across the country.
Manufacturers, distributors, and retailers of cough medicines are advised to ensure strict compliance with the licensing and regulatory requirements applicable under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945.
