In a significant move aimed at improving drug safety and curbing misuse, the Union Ministry of Health and Family Welfare has removed cough syrups from Schedule K of the Drugs Rules, 1945. The amendment means that cough syrups can now only be sold through licensed pharmacies, ending a long-standing exemption that allowed their sale in certain villages and non-pharmacy retail outlets.
The decision is intended to strengthen regulatory oversight over the manufacture, distribution, and sale of cough syrups, which have frequently come under scrutiny due to cases of misuse and contamination. Until now, Schedule K permitted specific medicines to be sold in villages with populations below 1,000 without requiring full compliance with retail drug licensing regulations.
With the latest amendment, cough syrups will no longer qualify for this exemption. As a result, their sale and dispensing must now take place exclusively through licensed pharmacies in accordance with the Drugs and Cosmetics Act, 1940.
The move follows growing concerns over the widespread misuse of cough syrups as an inexpensive substitute for alcohol and narcotic substances, particularly among vulnerable populations in both urban and rural areas. Authorities have also reported large-scale smuggling of India-made cough syrups across international borders, including into Bangladesh.
Safety concerns have further intensified regulatory scrutiny. In recent years, contaminated cough syrups linked to toxic substances such as diethylene glycol (DEG) have been associated with multiple child deaths in India and abroad. Last year, contaminated syrup reportedly led to the deaths of at least 22 children in Rajasthan, while Indian-manufactured cough syrups were previously linked to fatal incidents involving children in The Gambia and Uzbekistan.
According to the Health Ministry, the amendment reflects the need to align existing regulations with current public health and safety requirements. Officials believe the change will encourage responsible distribution practices, improve compliance with drug regulations, and enhance consumer protection across the country.
The ministry has also urged manufacturers, distributors, and retailers to strictly follow all licensing and regulatory requirements governing the sale of cough syrups, reinforcing the government’s commitment to ensuring safer access to medicines.
