Cough Syrups no longer for over-the-counter sale: Centre makes prescription mandatory
Babushahi Bureau
New Delhi, June 16, 2026:The Union Ministry of Health and Family Welfare has issued a significant notification tightening the regulatory framework for syrup-based medicines, including cough syrups, making them no longer available over the counter without a valid prescription from a registered medical practitioner.
The decision comes through an amendment to the Drugs Rules, 1945, aimed at strengthening regulatory oversight and ensuring safer distribution of syrup formulations across the country.
According to the notification issued under Gazette Notification G.S.R. 927 (E) dated December 29, 2025, the government has omitted the word “Syrup” from Schedule K, Serial No. 13, Entry 7 under the category of exempted drugs. This effectively removes earlier relaxations that allowed limited sale of cough syrups without full retail licensing requirements.
Schedule K of the Drugs Rules, 1945 previously provided exemptions from certain provisions of the Drugs and Cosmetics Act, 1940 for select categories of medicines. One such exemption permitted the sale of cough syrups in villages with populations below 1,000 without strict licensing compliance.
With the latest amendment now in effect, this exemption has been withdrawn. As a result, cough syrups can now only be sold and dispensed through duly licensed pharmacies operating under the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
Strengthening oversight of syrup-based medicines
The Ministry stated that the amendment has been introduced to enhance regulatory control over syrup formulations and align existing exemptions with current public health and safety requirements. The move is expected to ensure more responsible distribution, reduce misuse risks, and improve compliance standards nationwide.
Manufacturers, distributors, and retailers have been advised to strictly adhere to licensing norms and ensure full compliance with applicable legal provisions while dealing in cough syrup products.
Health officials believe the revised framework will help strengthen monitoring mechanisms, particularly in rural and semi-urban areas where regulatory gaps previously existed.
The notification marks a significant shift in India’s approach toward over-the-counter availability of syrup-based medicines, placing them firmly under prescription-controlled access.