By Shalini Bhardwaj, New Delhi, January 1
In a major step to ensure the safety of people, the government of India on has Proposed amendments for strict criteria on the sale of cough syrups over the counter.
The Union government has issued a draft of an important amendment to the Drugs Rules-1945. The Health Ministry has proposed removing the word 'syrup' from Schedule K. This step has been taken to make the drug-related rules clear and effective, so that public interest is protected. Suggestions and objections have been invited from the public within 30 days.
"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. " Reads notification issued by the Union Health Ministry
The Ministry of Health and Family Welfare has issued a draft notification to amend certain rules, seeking objections and suggestions from the public. The government has issued this draft under the Drugs and Cosmetics Act of 1940. These proposed changes have been made public after consulting the Drugs Technical Advisory Board.
"The following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub- section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government."
Recently, the World Health Organisation in October 2025 also issued an alert after several deaths of children and serious side effects linked to Coldrif cough syrup manufactured by Tamil Nadu based Sresan Pharmaceuticals.
According to Dr. Atul Kakar, Chairperson, Medicine, Sir Gangaram Hospital, "Recently, the word syrup which contains many of these syrups which are cough syrup have been banned by the government and in the month of October we did see lots of deaths happening in children in Rajasthan and Madhya Pradesh because of the cough syrup because they contained some substance which were poisonous. Also, I feel that the medicine should not be prescribed by the chemist and there should not be much excess of the drugs given by the chemist, so let's not limit ourselves to the syrups only, other medicines also should not be prescribed, and the government should be very strict in cutting down the medicines which are given by the chemist themselves."
"Removing syrups from the OTC exemption list is a timely and much-needed step. Liquid formulations are widely used in children, but they are also the most commonly misused--often given without correct dosing, age-appropriate indication, or medical supervision. Making syrups prescription-only will help curb self-medication, prevent dosing errors, and reduce unnecessary exposure to antibiotics, cough suppressants, and steroids. Ultimately, this move strengthens patient safety, especially for children, who are far more vulnerable to medication misuse." Said Dr Vivek Jain, Senior Director & Unit Head, Paediatrics, Fortis Hospital, Shalimar Bagh, Delhi.
- ANI
Reader Comments
We welcome thoughtful discussions from our readers. Please keep comments respectful and on-topic.