Exclusive: Coldrif Cough Syrup Contains Salt Banned 2 Years Ago For Children Under 4

Coldrif, the cough syrup at the centre of the controversy behind the death of 19 children in Madhya Pradesh, contains salts banned for use in children under the age of four, according to a 2023 order accessed by NDTV.

Prescribed in children to treat symptoms of cold and cough, including runny nose, sneezing and sore throat and watery eyes, Coldrif contains Chlorpheniramine Maleate, Paracetamol and Phenylephrine.

The central government order dated December 18, 2023, noted that the fixed-dose combination (FDC) of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg drop/ml "should not be used in children below four years of age."

The order, issued by the Central Drugs Standard Control Organisation, and undersigned by Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India, ordered firms to "mention warning" in this regard on label and package insert.

This means, all manufacturers of FDC are to mention "FDC should not be used in children below four years of age" on label and package insert or promotional literature of the drug, as per the directive.

However, it has been found that the pharmaceutical companies did not change the labels as asked. The state governments also did not ban the syrup or launch any awareness campaign regarding the use of cough syrup in children.

The 'Killer' Cough Syrup

Coldrif, a cough syrup manufactured by Sresan Pharmaceuticals in Tamil Nadu's Kancheepuram, is linked to the deaths of dozens of children in Madhya Pradesh and Rajasthan. On October 2, the Tamil Nadu drug control authorities declared that the Coldrif syrup sample they tested was adulterated. The sample contained diethylene glycol (48.6% w/v), a poisonous substance "which may render the contents injurious to health", the report said.

Diethylene glycol is used in the manufacture of printing ink, glue, brake fluid, and lubricants. Its consumption can cause severe kidney, liver, and nervous system damage in humans.

The symptoms begin with nausea, abdominal pain, and reduced urine. In severe cases, this progresses rapidly to acute kidney failure, seizures, and death.

Also Read: 'Poison Fed As Medicine': They Had A Cold, A Cough Syrup Killed Them

Pharma Companies Fail To Obtain WHO-GMP Certificate

In January 2023, the World Health Organization (WHO) called to protect children from "contaminated medicines". The death of over 300 children in at least seven countries was linked to the use of over-the-counter cough syrups with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG).

One such disaster played out in the Gambia in 2022 when at least 70 children died after consuming contaminated cough syrups. This was followed by a central government directive to obtain WHO-GMP certification.

Only 72 per cent of the Micro, Small, and Medium Enterprises (MSME) pharmaceutical companies in the country have obtained the quality certification. Of over 5,000 (5,308) MSME pharmaceutical companies, 3,838 companies have obtained certification. The remaining 1,470 companies have not yet applied.

Srisan Pharma, a company selling cough syrup in Madhya Pradesh, also lacked a GMP certification but continued to manufacture and sell generic drugs.

A CDSCO inspection found unbilled containers of DEG, a highly toxic chemical, at Srisan Pharma's factory. The company was adding 46-48 per cent of DEG to cough syrup against the permitted limit of only 0.1 per cent.

Also Read: Rust, Filth, Neglect: Factory Made 'Killer' Cough Syrup Despite Violations