New Delhi, June 16, 2026: The Union Ministry of Health and Family Welfare has amended the Drugs Rules, 1945, withdrawing a long-standing exemption that allowed cough syrups to be sold in villages with a population of less than 1,000 without certain retail licensing requirements.
According to a notification issued by the Ministry, the word “Syrup” has been removed from Entry No. 13 of Schedule K of the Drugs Rules, 1945. Schedule K lists categories of drugs that are exempt from specific provisions of the Drugs and Cosmetics Act, 1940 and related rules.
Previously, cough syrups could be sold in small villages without full compliance with retail sale licensing norms. Following the amendment, cough syrups can now be sold and dispensed only through duly licensed pharmacies, regardless of the village population.
The Ministry said the move is aimed at strengthening regulatory oversight of syrup formulations and ensuring that the distribution and sale of cough syrups meet current public health and safety standards. Officials believe the change will encourage responsible sale practices and improve compliance with drug regulations across the country.
Manufacturers, distributors and retailers have been advised to strictly follow all licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945.
The amendment is expected to enhance monitoring of cough syrup sales and support safer access to medicines in rural areas.
