The government has amended the Drugs Rules, 1945, removing cough syrups from Schedule K and ending their exemption from certain retail licensing requirements.
The Ministry of Health and Family Welfare notified the amendment through Gazette Notification G.S.R. 927(E) dated December 29, 2025, published in the Gazette of India Extraordinary, Part II, Section 3, Sub-section (i), on December 30, 2025. The amendment omits the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the heading “Class of Drugs”.
Schedule K of the Drugs Rules, 1945 provides exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 and related rules for specified classes of drugs. Before this amendment, Entry No. 13 of Schedule K allowed the sale of cough syrups in villages with populations below 1,000 without requiring compliance with certain retail sale licensing provisions.
Following the removal of this exemption, the sale and dispensing of cough syrups in smaller villages will now be required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940 and the Rules framed thereunder.
The government said the amendment has been made to strengthen regulatory oversight of syrup formulations and to align the exemption framework with current public health and patient safety requirements.
The move is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.
Manufacturers, distributors and retailers dealing with cough syrups have been advised to ensure strict adherence to the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945
