Kerala Paediatricians criticise Centre's cough syrup ban for children under 2

Written By :  Adity Saha
Published On 2025-10-09 11:18 GMT   |   Update On 2025-10-09 11:18 GMT
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Thiruvananthapuram: Amid rising concerns over certain cough syrups following the deaths of children in Madhya Pradesh due to contaminated formulations, the Union Health Ministry has advised that cough and cold medicines should not be prescribed or given to children below two years of age. 

The advisory has sparked outrage and criticism from paediatricians in Kerala, who are unhappy and have opposed the blanket ban on such medicines and asked for a clear definition of what counts as a “cough medicine” instead of disallowing all such medicines for children below two years.

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The Ministry has mentioned that cough and cold medications are generally not recommended for children below five years, and above that, any use should follow careful clinical evaluation with close supervision and strict adherence to appropriate dosing and avoiding multiple drug combinations.

Also read- MP Cough Syrup Case: Doctors' associations demand central probe, case withdrawal for arrested paediatrician

The Ministry has written to the Director of Health Services of all States and Union Territories in this regard. It said that most acute cough illnesses in children are self-limiting and often resolve without pharmacological intervention, as per the NewsonAir report.

The Ministry has requested that all State and UT Health Departments, District Health Authorities, and all Clinical Establishments implement and disseminate this advisory across government dispensaries, district hospitals, and medical institutions. In response, the Directorate General of Health Services (DGHS) has issued an advisory to all states and Union Territories on the rational use of cough syrups in children.

However, paediatricians in Kerala have criticised the directive, pointing out that the centre's disallowing cough and cold medicines should not be interpreted to mean that children under two years should be left untreated when they have a cough.

Calling the measure 'Extreme', a senior paediatrician told The Hindu, "Cough is just a symptom and children can be coughing due to many reasons, including allergic rhinitis or asthma, which can be very distressing for parents of young children. There are several classes of drugs which we use to treat these coughs, all of which fall under the “cough medicine” classification. In the current situation, the authorities should define what is a “cough” medicine, rather than disallowing all medications for kids below two years. There should be clarification on when children can be given “cough medicine” and which class of medicines may be safely prescribed."

According to the paediatricians, children, even those below two years with asthma, need bronchodilators, while those with allergic rhinitis would need to be prescribed antihistamines, both of which are used to treat coughs. Cough suppressants, on the other hand, should not be used for children below two years, as the preservatives used in these formulations may not be suitable for children.

“There are some decongestants in the market with irrational drug combinations which need to be avoided for children. Over-the-counter (OTC) cough medications for children should not be resorted to. But if parents feel that their young child has a significant cough, paediatricians should be able to treat it,” said, Indian Academy of Paediatrics, Kerala, president I. Riaz.

Dr. Riaz feels that while the blanket ban on cough medications for young children may not be rational, the IAP would like to use this opportunity to create awareness about good practices among parents, such as avoiding self-medication of children and not using OTC drugs.

Meanwhile, the Kerala health minister stated that the State Health Department is in the process of formulating clear-cut guidelines on the management of cough illnesses in children.

Medical Dialogues had reported that at least 11 children have died from kidney failure after consuming contaminated Coldrif cough syrup in Madhya Pradesh's Chhindwara district in the past 30 days. Following these deaths, police arrested Dr Pradeep Soni, a paediatrician posted at the Community Health Centre (CHC) in the town, who had prescribed the syrup, and registered him as an accused in the case. Apart from Dr Soni, the police have named the directors of a Tamil Nadu-based pharmaceutical company (M/s Sresan Pharmaceuticals, Kanchipuram, Tamil Nadu) as the second accused in the case.

After his arrest, the doctor confessed he had been prescribing the same cough syrup for the past 15 years to children suffering from cough and fever, completely unaware that it was contaminated. He said he could never have imagined that the syrup could be unsafe. The Coldrif cough syrup in question was manufactured by Sresun Pharmaceuticals. During a government quality check, it was found to contain Diethylene Glycol (DEG) far beyond the permissible limit, which is - 48.6%. DEG is an industrial chemical known to cause kidney failure and death.

Also read- MP Cough Syrup Deaths: IMA slams Paediatrician's arrest as unfair

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