New Delhi: The Union Ministry of Health and Family Welfare has tightened regulations governing the sale of cough syrups by withdrawing a long-standing exemption that allowed their sale in small villages without standard licensing requirements.
The amendment to the Drugs Rules, 1945, notified by the ministry, removes the word “Syrup” from a category of medicines listed under Schedule K, effectively ending a regulatory exemption that previously applied to cough syrups in villages with populations below 1,000.
Under the earlier provision, certain cough syrups could be sold in remote villages without full compliance with retail licensing norms under the Drugs and Cosmetics Act, 1940. Following the amendment, cough syrups can now be sold and dispensed only through duly licensed pharmacies, even in smaller rural areas.
The change was notified through Gazette Notification G.S.R. 927(E), issued on December 29, 2025 and published in the Gazette of India on December 30, 2025. The Ministry of Health and Family Welfare said the move seeks to strengthen regulatory oversight and align medicine distribution norms with current public health and safety standards.
According to the ministry, the amendment is aimed at ensuring more responsible sale and distribution of syrup formulations, particularly cough syrups, while improving compliance with existing drug regulations across the country.
“The amendment has been undertaken to strengthen regulatory oversight of syrup formulations and to align the exemption framework with contemporary public health and safety requirements. The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country,” the ministry said in an official release.
“Manufacturers, distributors and retailers dealing with cough syrups are advised to ensure strict adherence to the applicable licensing and regulatory requirements under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945,” it added.
The revised rule comes amid growing concerns over the misuse of cough syrups and several incidents in recent years involving allegedly contaminated syrup-based medicines linked to fatalities, including among children.
