Deadly Oversight: Coldrif Cough Syrup Contains Banned Ingredients Linked to Multiple Child Deaths in India

Coldrif samples analyzed in Tamil Nadu were discovered to be contaminated with harmful substances.

New Delhi:

According to a 2023 governmental directive obtained by NDTV, Coldrif, the controversial cough syrup linked to 19 children's deaths in Madhya Pradesh, contains ingredients prohibited for administration to children younger than four years.

Commonly prescribed to treat pediatric cold and cough symptoms including runny nose, sneezing, sore throat, and watery eyes, Coldrif contains a combination of Chlorpheniramine Maleate, Paracetamol, and Phenylephrine.

The central government directive dated December 18, 2023, specifically stated 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."

This order, issued by the Central Drugs Standard Control Organisation and signed by Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India, instructed pharmaceutical companies to clearly include warning labels on their packaging and inserts.

The directive mandated all FDC manufacturers to explicitly state "FDC should not be used in children below four years of age" on product labels, package inserts, and promotional materials.

However, investigations revealed that pharmaceutical companies failed to update their labeling as required. Additionally, state governments neither prohibited the syrup nor initiated awareness campaigns regarding the potential dangers of administering these cough syrups to children.

The 'Deadly' Cough Syrup

Coldrif, manufactured by Sresan Pharmaceuticals in Kancheepuram, Tamil Nadu, has been connected to numerous child fatalities in Madhya Pradesh and Rajasthan. On October 2, Tamil Nadu drug control authorities confirmed that tested Coldrif syrup samples contained diethylene glycol (48.6% w/v), a toxic substance "which may render the contents injurious to health."

Diethylene glycol is an industrial chemical used in manufacturing printing ink, adhesives, brake fluid, and lubricants. Human consumption can cause devastating damage to the kidneys, liver, and nervous system.

Initial symptoms include nausea, abdominal discomfort, and decreased urination. Severe cases rapidly progress to acute kidney failure, seizures, and ultimately death.

Pharmaceutical Companies' Failure to Obtain WHO-GMP Certification

In January 2023, the World Health Organization (WHO) issued a global alert regarding contaminated medicines threatening children's safety. Over 300 child deaths across at least seven countries were associated with over-the-counter cough syrups containing confirmed or suspected high levels of diethylene glycol (DEG) and ethylene glycol (EG).

A similar tragedy unfolded in Gambia during 2022, where at least 70 children perished after consuming tainted cough medications. Following this incident, the Indian central government mandated WHO-GMP certification for pharmaceutical manufacturers.

Despite this requirement, only 72 percent of India's Micro, Small, and Medium Enterprises (MSME) pharmaceutical companies have secured the quality certification. Of the approximately 5,308 MSME pharmaceutical operations nationwide, 3,838 have obtained certification while 1,470 companies have yet to apply.

Srisan Pharma, the company distributing cough syrup in Madhya Pradesh, lacked GMP certification but continued manufacturing and selling generic medications.

A subsequent inspection by CDSCO discovered unbilled containers of DEG, a highly toxic substance, at Srisan Pharma's production facility. The company was incorporating 46-48 percent DEG in its cough syrup formulations, drastically exceeding the permitted limit of only 0.1 percent.