Toxic Cough Syrup Tragedy Triggers Nationwide Mandatory Testing Reform in India

The reform comes as the death toll continues to rise in Madhya Pradesh, with contaminated Coldrif syrup identified as the culprit.

Rising Death Toll Across States

The tragic toll has steadily climbed, with 22 children confirmed dead in Madhya Pradesh's Chhindwara district alone as of October 9, 2025. The victims, all aged five or younger, include five-year-old Vishal and four-year-old Mayank Suryavanshi from Parasia town, who died at a Nagpur hospital. Additional fatalities have been reported in Betul district, where four-year-old Kabir and two-and-a-half-year-old Garmit died after developing severe kidney complications following consumption of the syrup.

Beyond Madhya Pradesh, the tragedy has extended to Rajasthan, where three children in Bharatpur, Sikar, and Churu districts have also died after consuming contaminated syrups. The Nagpur Government Medical College has reported additional deaths, possibly linked to toxic syrup, bringing the total suspected fatalities across regions even higher.

Toxic Contamination Revealed in Laboratory Tests

Laboratory analysis has confirmed that Coldrif syrup contained diethylene glycol (DEG) at 48.6% - nearly 500 times the permissible safety limit of 0.1% set by the World Health Organization and India's Central Drugs Standard Control Organisation. DEG is an industrial solvent used in manufacturing paints, brake fluids, and antifreeze coolants, and is highly toxic to humans.

When ingested, DEG breaks down into toxic acids that trigger metabolic acidosis, causing irreversible kidney damage, neurological symptoms, and ultimately death. According to health experts, these contaminants turn medicinal syrups into "slow poisons" that systematically shut down children's organs.

Nationwide Regulatory Response and Testing Mandate

In response to the crisis, the central government has made testing for diethylene glycol (DEG) and ethylene glycol (EG) mandatory for all oral syrups. This reform, part of the Draft Drugs (Second Amendment) Rules, 2025, represents the most significant regulatory overhaul in decades:

· Enhanced testing protocols: Strict enforcement of raw material and finished product testing aligned with global standards

· State-level crackdowns: Multiple states including Uttar Pradesh, Uttarakhand, Kerala, Tamil Nadu, Karnataka, Rajasthan, and Madhya Pradesh have banned Coldrif and similar syrups

· Comprehensive inspections: Widespread sampling of cough syrups and raw materials across manufacturing units and supply chains

Accountability and Compensation Measures

Law enforcement and regulatory agencies have moved swiftly to assign responsibility:

 Ranganathan Govindan, owner of Sresan Pharma (manufacturer of Coldrif), was arrested in Chennai and faces charges of culpable homicide and drug adulteration

· The manufacturing unit has been sealed, with all products from the company removed from sale pending further testing

· Dr. Praveen Soni, a government doctor from Parasia who prescribed the syrup, was arrested and suspended from service

· The Madhya Pradesh Chief Minister has announced compensation of ₹4 lakh (approximately $4,800) for each affected family

Global Context and Historical Failures

This tragedy echoes similar incidents that have damaged India's reputation as the "pharmacy of the Global South". Since 2022, over 300 children worldwide have died from toxic cough syrups originating from Indian manufacturers:

· The Gambia (2022): 66 children died after consuming syrups made by Maiden Pharmaceuticals

· Uzbekistan (2022): 18 children died from contaminated Dok-1 Max syrup

· Cameroon (2023): 6 children died after taking Naturcold syrup containing high DEG levels

These repeated incidents reveal persistent regulatory failures, including inadequate testing, corporate cost-cutting, and jurisdictional gaps between central and state authorities that manufacturers exploit.

A Preventable Tragedy Sparks Reform

As investigations continue and the Special Investigation Team pursues further accountability, the national mandate for DEG and EG testing represents a critical step toward preventing future tragedies. However, the successful implementation of these reforms across India's vast pharmaceutical landscape - comprising over 13,000 licensed manufacturers - remains the crucial challenge ahead.

The heartbreaking deaths of these children underscores an urgent need for sustained regulatory vigilance, corporate responsibility, and global cooperation to ensure that medicines meant to heal do not become instruments of tragedy.