Deadly Cough Syrup Scandal: 23 Children Die as CAG Report Reveals Systemic Failures in Drug Testing

New Delhi:

Significant findings have emerged regarding the reality of drug testing procedures amid an investigation into the deaths of nearly two dozen children who consumed contaminated cough syrup. The Comptroller and Auditor General of India (CAG) had previously highlighted the poor management of medicine stores in Madhya Pradesh's Chhindwara district, where most of these fatalities occurred. The audit also noted a considerable deficit in drug testing in Tamil Nadu, suggesting serious oversight by pharmaceutical regulatory authorities.

The renewed scrutiny of drug testing protocols follows the tragic deaths of 23 children in Madhya Pradesh. These fatalities have been connected to Coldrif syrup manufactured by Sresan Pharmaceuticals, a company based in Tamil Nadu.

What CAG Said In 2024

The CAG's performance audit examining public health infrastructure and health services management, presented on December 10, 2024, identified significant shortfalls in meeting drug inspection targets and sample collection.

In 2016-17, Tamil Nadu authorities were tasked with conducting 1,00,800 inspections. However, only 66,331 were completed, representing a 34% shortfall. By 2020-21, this deficit increased to 38%, with just 62,358 inspections carried out of the targeted 1,00,800.

Between 2016 and 2021, the most substantial shortfall was recorded at 40% during the 2019-20 period.

The CAG also identified deficits in the collection of drug samples for testing by inspectors. During this timeframe, the shortfall reached 54% in both 2018-19 and 2020-21.

Drug inspections constitute a crucial step in pharmaceutical production processes, designed to ensure medication quality and prevent adulteration. These inspections are conducted by specialized drug inspectors. Medications only reach retail outlets and medical facilities after receiving proper clearance.

Toxic Substance In Coldrif

Samples of Coldrif, a medication prescribed for pediatric cold and cough symptoms, were declared adulterated by Tamil Nadu authorities earlier this month after testing revealed the presence of diethylene glycol (DEG). DEG is a toxic substance used in manufacturing printing ink and adhesives that can cause severe damage to the kidneys, liver, and nervous system in humans.

A subsequent inspection discovered undocumented containers of DEG at Sresan's Kancheepuram facility and revealed that the company was incorporating 46-48% DEG into the Coldrif cough syrup, drastically exceeding the permitted limit of 0.1%.

The Tamil Nadu Drugs Control Authority subsequently issued an order to halt production and froze all inventory. The company's operating license was also suspended.

Sresan Pharma's owner, Ranganathan Govindan, has since been arrested.

Madhya Pradesh Blames Tamil Nadu

Madhya Pradesh Chief Minister Mohan Yadav has attributed responsibility to the Tamil Nadu government for the deaths of over 23 children in his state, characterizing it as a failure of regulatory vigilance and timely intervention. "The deaths have occurred due to manufacturing defects of the cough syrup, which was being produced at the factory in Tamil Nadu. Therefore, timely action and sampling should first have been initiated there," he stated.