At least 19 children under the age of five have died in Madhya Pradesh’s Chhindwara district after consuming a contaminated batch of Coldrif cough syrup, triggering a nationwide investigation into pharmaceutical safety standards. Manufactured by Tamil Nadu-based Sresan Pharmaceuticals, the syrup contained diethylene glycol (DEG)—a toxic industrial solvent—at nearly 500 times the permissible limit. The company’s owner was arrested on Thursday, according to Reuters.
Health officials attributed the deaths to acute kidney failure caused by DEG poisoning. The Central Drugs Standard Control Organisation (CDSCO) has recalled the product and sealed the company’s Tamil Nadu manufacturing unit. A Special Investigation Team has been formed, and the World Health Organization has requested details on whether the batch was exported.
The Coldrif incident has prompted a broader review of paediatric syrups sold in India. Two additional products—Respifresh TR and ReLife—manufactured by Gujarat-based firms, have also been flagged for DEG contamination, though not yet linked to fatalities. Both have been recalled, and state drug controllers have been instructed to intensify testing of all syrups currently in circulation.
This isn’t the first time DEG contamination has led to child deaths. Over the past two years, Indian-made syrups have been implicated in the deaths of at least 141 children across Gambia, Uzbekistan, and Cameroon. In each case, DEG poisoning was identified as the cause, sparking international outrage and calls for tighter regulation of India’s pharmaceutical exports.
While India now mandates pre-export testing for syrups, domestic batches—like Coldrif—often bypass similar scrutiny. Experts say this regulatory gap leaves millions vulnerable and underscores the need for uniform quality checks across both domestic and international supply chains.
The contamination reportedly stems from the use of industrial-grade solvents in place of pharmaceutical-grade ones. Ingredients like polyethylene glycol and glycerine, commonly used in syrups, are available in both grades. While the pharmaceutical version is tightly regulated, the industrial variant—used in products like antifreeze—can contain high levels of diethylene glycol.
Manufacturers may opt for cheaper industrial-grade inputs, especially when regulatory oversight is lax. India’s drug regulation is split between central and state authorities, often resulting in inconsistent enforcement. While export-bound syrups now undergo mandatory testing, domestic batches are not held to the same standard, leaving a dangerous gap in quality control.
India is one of the world’s largest producers and exporters of generic medicines, often referred to as the ‘pharmacy of the global south’. Its drugs reach dozens of countries across Asia, Africa, and Latin America. But repeated incidents of diethylene glycol contamination—both at home and abroad—have raised serious concerns about the country’s quality control mechanisms.
While export-bound syrups now face mandatory testing, domestic formulations are still vulnerable, as seen in the Chhindwara deaths. Experts warn that without uniform standards, batch-level testing, and stricter supplier audits, the risk of toxic contamination remains high.
So, what can be done to prevent the same? According to Dr Anish Pillai, lead consultant – neonatology and paediatrics at Motherhood Hospitals, Kharghar, Mumbai, “Ensuring medicine safety starts with the basics—procuring drugs only from licensed distributors and government-approved suppliers.” Additionally, he believes that every child’s response to medication must be closely monitored carefully. Pillai adds, “Pharmacists and hospital procurement committees play a vital role in maintaining consistent quality control, and their involvement is key to preventing such tragedies.”
“We talk about regulatory compliance, regulation, inspections, but that’s not what quality is about. Quality is about the patient’s safety, the efficacy and purity of the product,” GV Prasad, co-chairman and managing director of Dr Reddy’s Laboratories said during a panel discussion at Indian Pharmaceutical Alliance’s 9th edition of the Global Pharmaceutical Quality Summit 2024. He added that it is high time we focus on creating a quality culture in the Indian pharma industry—not just the larger pharma companies, but also smaller companies. “It should be something of an absolute. If a small dosage can cure you, a small impurity can also harm you. So, it’s necessary to embrace patient centricity in quality, and design your systems around that.”
First Published: Oct 10, 2025, 12:34
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