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 &amp; Unit Head, Paediatrics, Fortis Hospital, Shalimar Bagh, Delhi.&nbsp; &nbsp;

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. 

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.

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.&nbsp;

India proposes stricter Drugs Rules to restrict over the counter sale of cough syrups

According to a report by India's Central Drug Control Organisation, about 50 companies that are in business of producing cough syrups in India have reportedly failed quality tests.

India: Over 50 cough syrup companies fail quality tests; WHO links bad quality syrups to deaths

The World Health Organization (WHO) has issued an alert over an India-made cough syrup that was sold in Iraq after it was found contaminated and deemed “not safe for use”.

The alert came after a sample of the common cold syrup, ‘Cold Out’, was obtained from a location in Iraq and submitted for laboratory analysis.

"The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%," the health body said.

The WHO said that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

The syrup was manufactured by Fourrts (India) Laboratories Pvt. Ltd, a Chennai-based plant, and the product is stated to be manufactured for Dabilife Pharma Pvt. Ltd. India, the WHO said in a statement.

"To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product," the alert said.

It said that this syrup may have marketing authorisations in other countries or regions.

<h2>Toxic chemical&nbsp;</h2>

"The substandard batch of the product is unsafe and its use, especially in children, may result in serious injury or death," the alert warned.

"Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death," the WHO said.

The Iraqi officials have not yet found any deaths related to poisonous medications, but last week the Ministry of Health&nbsp;said that the medicine failed separate tests conducted by Iraqi authorities and that products circulating in the market were being confiscated.

<h2>Fifth time&nbsp;</h2>

This is the fifth time that contaminated syrups have been tied to an Indian manufacturer.

Cases of Indian-made tainted cold syrups have been reported in Indonesia,&nbsp;Gambia, Uzbekistan and&nbsp;Cameroon, and have killed about 300 children in the past year, reports Bloomberg.

The Indian manufacturer Marion Biotech, which had exported the syrups to Uzbekistan, had its drug license cancelled by the Uttar Pradesh government.

The company involved in Gambia, Maiden Pharmaceuticals, denied that its drugs were responsible for the deaths in the country. Later, tests by an Indian government laboratory found no toxins in the syrup.

According to Reuters, DCGI (Drugs Controller General of India) chief VG Somani wrote to WHO, saying the samples of Maiden's syrup had not been contaminated with ethylene glycol and diethylene glycol.

(With inputs from agencies)

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The World Health Organization (WHO) has issued an alert over an India-made cough syrup that was sold in Iraq after it was found contaminated and deemed “not safe for use”.

The World Health Organization (WHO) has issued an alert over an India-made cough syrup that was sold in Iraq after it was found contaminated and deemed “not safe for use”. The alert came after a sample of the common cold syrup, ‘Cold Out’, was obtained from a location in Iraq and submitted for laboratory analysis. "The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%," the health body said. The WHO said that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. The syrup was manufactured by Fourrts (India) Laboratories Pvt. Ltd, a Chennai-based plant, and the product is stated to be manufactured for Dabilife Pharma Pvt. Ltd. India, the WHO said in a statement. "To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product," the alert said. It said that this syrup may have marketing authorisations in other countries or regions. Toxic chemical "The substandard batch of the product is unsafe and its use, especially in children, may result in serious injury or death," the alert warned. "Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death," the WHO said. The Iraqi officials have not yet found any deaths related to poisonous medications, but last week the Ministry of Health said that the medicine failed separate tests conducted by Iraqi authorities and that products circulating in the market were being confiscated. Fifth time This is the fifth time that contaminated syrups have been tied to an Indian manufacturer. Cases of Indian-made tainted cold syrups have been reported in Indonesia, Gambia, Uzbekistan and Cameroon, and have killed about 300 children in the past year, reports Bloomberg. The Indian manufacturer Marion Biotech, which had exported the syrups to Uzbekistan, had its drug license cancelled by the Uttar Pradesh government. The company involved in Gambia, Maiden Pharmaceuticals, denied that its drugs were responsible for the deaths in the country. Later, tests by an Indian government laboratory found no toxins in the syrup. According to Reuters, DCGI (Drugs Controller General of India) chief VG Somani wrote to WHO, saying the samples of Maiden's syrup had not been contaminated with ethylene glycol and diethylene glycol. (With inputs from agencies) WATCH WION LIVE HERE

WHO issues alert over ‘contaminated’ India-made cough syrup sold in Iraq  

India suspended production at a pharmaceutical company after its cough syrup was linked to the death of 19 children in Uzbekistan. The cough syrup was manufactured by the Indian drug-maker Marion Biotech and has killed at least 19 children in Uzbekistan's Samarkand.

Uzbekistan: Cough syrup kills 19 children, country blames India-made syrups for deaths