Over 700 Cough Syrup Manufacturers Face Intense Scrutiny: DEG-Linked Child Deaths Trigger Nationwide Crackdown

The Indian government has launched a nationwide crackdown on paediatric cough syrup manufacturers following reports of child deaths linked to contaminated medicines. More than 700 manufacturers are now under intensive audits by central and state drug regulators, as part of measures to ensure strict compliance with drug quality and safety standards, Minister of State for Health Anupriya Patel informed the Rajya Sabha.

Cluster of Fatalities in Madhya Pradesh Triggers Investigation

The crackdown was prompted by a series of child deaths in Chhindwara district, Madhya Pradesh. In response, a multidisciplinary expert team from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and Central Drugs Standard Control Organisation (CDSCO) conducted field investigations in Chhindwara and Nagpur, coordinating with state authorities.

Investigators collected 19 samples of medicines consumed by the affected children from clinics and nearby pharmacies. Laboratory testing revealed that:

• 15 samples met standard quality requirements
• 4 samples were declared Not of Standard Quality (NSQ)

Deadly Contaminant: Diethylene Glycol in Coldrif Syrup

Testing identified the Coldrif Syrup manufactured by Sresan Pharmaceuticals, Kancheepuram, Tamil Nadu, as containing 46.28% Diethylene Glycol (DEG). DEG and Ethylene Glycol (EG) are highly toxic industrial chemicals that can cause acute kidney failure, neurological damage, and death, particularly in children.

Factory Inspections Reveal Severe GMP Violations

CDSCO inspections of Sresan Pharmaceuticals flagged serious Good Manufacturing Practices (GMP) lapses, including unhygienic production and improper storage conditions. Consequences included:

• Cancellation of the company’s manufacturing licence
• Filing of criminal cases in Madhya Pradesh and Tamil Nadu
• Arrests of responsible personnel
• Immediate recall and sales ban in Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry

Stricter Guidelines and Regulatory Reforms

To prevent future tragedies, the Central Drugs Controller has issued several directives:

Additionally, the Indian Pharmacopoeia Commission (IPC) has updated IP-2022 to mandate DEG and EG testing at both raw material and finished product stages before market release, aligning with global safety standards.

Zero Tolerance for Drug Safety Breaches

Minister Patel emphasized the government’s zero-tolerance stance toward pharmaceutical negligence, particularly in safeguarding children, who are most vulnerable to adverse drug reactions. The crackdown represents a significant effort to strengthen drug safety oversight and restore public confidence in paediatric medicines.