Govt tightens sale of cough syrups
The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country. - Union Ministry of Health and Family welfare
The Union Ministry of Health and Family Welfare has tightened rules related to sale of cough syrups in the country. The amendment, called the Drugs (Fifth Amendment) Rules, 2026, was published in the official gazette and removes the word “syrup” from Entry No. 13 of Schedule K of the Drugs Rules, 1945, to end the exemption allowing cough syrups to be sold in small villages without full retail licensing.
Schedule K gives certain drugs exemptions from rules, but only under specific conditions. This update brings the rules in line with current public health needs and improves oversight of liquid medicines. Before this change, cough syrups could be sold in villages with fewer than 1,000 people without complying with certain retail licensing rules under the Drugs and Cosmetics Act, 1940.
“Consequently, 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 ministry said.
This decision follows a draft notification issued in December 2025 that sought stakeholder feedback. Officials said the amendment is meant to encourage responsible distribution and sale of cough syrups and to improve compliance.
The Health Ministry said, “The measure is expected to promote responsible distribution and sale of cough syrups while ensuring greater compliance with regulatory standards across the country.”
They also advised, “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.”
This change follows increased attention on cough syrups and other liquid medicines, after reports of contamination-related deaths of children in several countries led regulators to tighten quality controls. Sources say the amendment will improve traceability and oversight by ensuring that all cough syrup makers and sellers comply with stricter licensing and quality standards.
The ministry said these changes aim to protect public health without making access too difficult, since licensed pharmacies are still common in rural areas. Officials have asked everyone in the pharmaceutical supply chain to review their operations and ensure full compliance with the rules to avoid regulatory action.
