Updated 1 January 2026 at 14:23 IST
India Proposes Stricter Rules on Cough Syrup Sales After Child Deaths
The Indian government has proposed strict new rules to curb over‑the‑counter sale of cough syrups by removing them from Schedule K of the Drugs Rules, 1945. The move follows WHO alerts and child deaths linked to contaminated syrups, aiming to strengthen patient safety and prevent misuse, especially among children.
The Union Health Ministry has proposed strict new rules to curb the over‑the‑counter sale of cough syrups, following a series of child deaths linked to contaminated medicines. A draft notification under the Drugs and Cosmetics Act, 1940 seeks to remove the word “syrup” from Schedule K of the Drugs Rules, 1945, effectively making syrups prescription‑only drugs.
The draft, titled the Drugs (Amendment) Rules, 2025, has been published for public consultation. Citizens have 30 days to submit objections or suggestions before the rules are finalized and notified in the Gazette of India.
"These rules may be called the Drugs (Amendment) Rules, 2025. They shall come into force on the date of their publication in the Official Gazette. In the Drugs Rules, 1945, in Schedule K, in the Serial No. 13, under the column "'Class of Drugs`, in the Entry No. 7, the word "Syrup,'' shall be omitted. "
This move comes after the World Health Organisation (WHO) issued an alert in October 2025, warning of serious side effects and deaths linked to Coldrif cough syrup manufactured by Tamil Nadu‑based Sresan Pharmaceuticals. Reports confirmed that at least 26 children died in Madhya Pradesh’s Chhindwara and Betul districts, while over 20 deaths nationwide were tied to the contaminated syrup. Survivors have been left with lasting disabilities, including blindness and paralysis.
Medical experts say the government’s step is overdue. Dr. Atul Kakar, Chairperson of Medicine at Sir Gangaram Hospital, noted that chemists often dispense syrups without prescriptions, leading to misuse. “We saw many deaths in children due to poisonous cough syrups. The government must be strict not only with syrups but also with other drugs handed out without medical supervision,” he said.
Dr. Vivek Jain, Senior Director of Paediatrics at Fortis Hospital, Shalimar Bagh, added that liquid formulations are widely misused in children. “Making syrups prescription‑only will help curb self‑medication, prevent dosing errors, and reduce unnecessary exposure to antibiotics, cough suppressants, and steroids. This strengthens patient safety, especially for children who are far more vulnerable.”
The Health Ministry’s draft amendment reflects growing concern over drug safety lapses in India. By tightening rules on cough syrups, the government aims to prevent further tragedies and restore public trust in the country’s regulatory system.
Published By : Priya Pathak
Published On: 1 January 2026 at 13:56 IST