Amid rising concerns over child deaths potentially linked to contaminated cough syrups, the Central government has issued an advisory against prescribing or dispensing cough and cold medications to children below two years of age. The advisory further states that these medications are generally not recommended for children under five, and their use in older children should only follow careful clinical evaluation and close supervision.
This directive follows reports of child deaths in Madhya Pradesh and Rajasthan allegedly linked to the consumption of cough syrups. The Union Health Ministry has communicated this advisory to the Director of Health Services in all States and Union Territories.
In Madhya Pradesh, nine children have died after allegedly consuming cough syrups that led to kidney ailments. The state government has banned the sale of Coldrif syrup following these deaths, which were suspected to be due to kidney infections in the Chhindwara district. Chief Minister Mohan Yadav described the deaths as "extremely tragic". The implicated syrup was manufactured in a factory in Kanchipuram, prompting the state government to request an inquiry from Tamil Nadu.
Conflicting reports have emerged regarding the presence of contaminants in the cough syrups. Initial investigations by national and state health authorities in Madhya Pradesh found no traces of Diethylene Glycol (DEG) or Ethylene Glycol (EG), toxic substances known to cause kidney injury. However, Tamil Nadu's drug regulator confirmed DEG contamination in samples taken directly from the manufacturing site of Sresan Pharma in Kanchipuram, leading to an immediate stop production order for the Coldrif brand.
In Rajasthan, two deaths have been reported, with several other children developing complications after taking a cough syrup distributed under the Chief Minister's Free Medicine Scheme. The state government has suspended Drug Controller Rajaram Sharma and halted the distribution of all 19 medicines supplied by Kayson Pharma. While the health department denies a direct link between the deaths and the cough syrup, pending test results and a formal investigation are underway. The cough syrup in question is a dextromethorphan-based formulation, which is not recommended for pediatric use.
The recent incidents have prompted increased scrutiny of pharmaceutical quality control. Since 2012, over 10,000 samples of medicines from Kayson Pharma have been tested, with 42 found to be substandard. The Union Health Ministry has initiated inspections of 19 drug manufacturers across six states to identify and rectify quality control lapses.
Health experts emphasize the dangers of DEG and EG contamination, as these substances can damage the kidneys, liver, and nervous system, with children being particularly vulnerable. Symptoms of poisoning include nausea, vomiting, and abdominal pain, potentially leading to kidney failure and death.
The Directorate General of Health Services (DGHS) has recommended non-pharmacological measures, such as adequate hydration and rest, as the first-line approach for managing coughs and colds in children. This advisory underscores the importance of cautious and judicious use of medications in pediatric populations, especially in light of the recent tragedies.
