Following Tamil Nadu, Madhya Pradesh and Kerala, five more states have banned the sale and distribution of Coldrif cough syrup, which is allegedly linked to the death of 16 children.

The states are Karnataka, Punjab, Himachal Pradesh, Uttar Pradesh and Puducherry.

This came after 16 children, aged between one and seven, died due to kidney failure in the past month in Madhya Pradesh and Rajasthan after consuming the cough syrup.

The Madhya Pradesh government had asked authorities in Tamil Nadu to look into the safety of the formulation. On October 2, a report by the Tamil Nadu director of drug control found that samples of Coldrif cough syrup manufactured at a plant of Sresan Pharmaceuticals in the state’s Kancheepuram district were found to be “NSQ”, or not of standard quality.

The report said that the samples contained 48.6% diethylene glycol, which can cause acute kidney and liver failure.

Following Tamil Nadu’s finding, on October 5, Madhya Pradesh also reported that one sample of Coldrif had 48.6% of diethylene glycol in it.

The permissible limit of diethylene glycol as an impurity is 0.1%. However, drug officials Scroll spoke to said that the chemical is unsafe even in trace amounts and should ideally be completely absent from an ingestible syrup. Its presence is a serious quality compliance issue, the officials said.

On Sunday, the Uttar Pradesh government banned the sale, import and export of Coldrif cough syrup, ANI reported.

The Karnataka government followed suit on Monday and banned the use of any cold and cough syrup for children below the age of two, while prohibiting the use of Coldrif cough syrup, The Indian Express reported.

On the same day, the Punjab Food and Drugs Administration also banned the sale, distribution and use of Coldrif cough syrup, PTI reported.

In Himachal Pradesh, authorities have completely banned the use of Coldrif cough syrup, while another syrup produced in the state, by the name Nastro-DS, is under scrutiny despite a clean chit from the Madhya Pradesh food and drugs administration, The New Indian Express reported.

“The lab analysis of Nastro-DS cough syrup samples has shown the presence of diethylene glycol within permissible limits,” Himachal Pradesh Drug Controller Manish Kapoor was quoted as saying. “Aqunova Pharma voluntarily decided to put on hold the production of Nastro-DS cough syrup after the Madhya Pradesh FDA took the samples.”

The Puducherry Drug Control Department has also prohibited the purchase, distribution and sale of a specific batch of Coldrif syrup.

In 2023, an inquiry by the World Health Organization had found diethylene glycol in India-made cough syrups allegedly linked to the deaths of 70 children in The Gambia.

In the wake of the deaths, the Directorate General of Health Services on Friday issued an advisory to all states and Union Territories, reiterating the “judicious prescribing and dispensing” of cough syrups for children.

The department, which reports to the Union health ministry, said that most “acute cough illnesses in children are self-limiting and resolve without pharmacological intervention”, adding that cough and cold medications should not be prescribed for children under two years.

Gujarat bans two other cough syrups

On Tuesday, the Gujarat Food and Drugs Control Administration banned the use of Respifresh TR and Relife – two other cough syrups that were found to have diethylene glycol beyond permissible levels.

On Monday, the Madhya Pradesh drug controller had labelled the two syrups that were manufactured in Gujarat as “not of standard quality”.

Of the 13 samples of the cough syrups collected by the Chhindwara drug inspector, 10 were assessed as being of “standard quality”, while three were found to be “not of standard quality”.

PIL before SC urges probe into deaths

Meanwhile, a lawyer has filed a public interest litigation before the Supreme Court seeking an independent, court-monitored probe into the deaths of multiple children in Rajasthan and Madhya Pradesh, Bar and Bench reported on Tuesday.

The petition highlighted that “no nationwide recall was initiated by the Union Ministry of Health and Family Welfare or the Central Drugs Standard Control Organisation, thereby allowing continued sale of the toxic drug in other states”.

The plea called for a look into forming a national drug recall policy in the country.

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