Indian police arrest proprietor of cough syrup agency linked to deaths of 17 youngsters – Life Pulse Daily

Introduction

The recent arrest of S. Ranganathan, the owner of Sresan Pharmaceutical Manufacturer, has reignited concerns about pharmaceutical safety in India. The company’s cough‑syrup brand “Coldrif” has been linked to the tragic deaths of 17 children under five years old in Madhya Pradesh. The deaths were caused by the presence of the highly toxic solvent diethylene glycol (DEG), found in concentrations far exceeding the permissible limit. This article examines the facts of the case, the regulatory gaps that allowed it to happen, and the broader implications for Indian drug manufacturers and consumers worldwide.

Analysis

Background of the Coldrif Tragedy

In early October 2025, health officials in the central Indian state of Madhya Pradesh reported a sudden spike in pediatric deaths. Autopsies revealed acute renal failure consistent with diethylene glycol poisoning. Investigations traced the source to “Coldrif,” a cough‑syrup marketed by Sresan Pharma, a company based in Tamil Nadu. Laboratory tests confirmed that the syrup contained DEG at levels nearly 500 times the maximum permissible concentration set by the Indian Pharmacopoeia.

What Is Diethylene Glycol?

Diethylene glycol is a colourless, sweet‑tasting liquid used industrially as a solvent and antifreeze. While it is inexpensive, it is also nephrotoxic and can cause rapid kidney failure when ingested. Because of its sweet taste, it has historically been used as a counterfeit sweetener in illicit food and pharmaceutical products, leading to several high‑profile poisoning incidents worldwide.

Regulatory Framework in India

India’s drug‑regulation system is overseen by the Central Drugs Standard Control Organization (CDSCO) and state‑level drug controllers. The law requires manufacturers to:

• Test every batch of raw material for contaminants.
• Perform final‑product quality checks in government‑accredited labs.
• Obtain a licence for each type of formulation before marketing.

Since 2023, exported cough syrups have faced an extra layer of testing after a series of deaths in Gambia, Uzbekistan, and Cameroon were linked to Indian products. However, the Coldrif case shows that domestic surveillance is still insufficient.

Timeline of Key Events

International Context

The World Health Organization (WHO) has described the incident as a “regulatory gap” that jeopardises both domestic patients and export markets. India accounts for roughly 40 % of generic medicines used in the United States and supplies more than 90 % of essential medicines in many African nations. Any lapse in quality control can therefore have global repercussions.

Summary

The Coldrif tragedy underscores three critical failures:

1. Manufacturing oversight: Inadequate testing allowed DEG to contaminate a widely used pediatric product.
2. Regulatory enforcement: Despite existing laws, batch‑level inspections were either missed or insufficient.
3. Consumer awareness: Parents lacked reliable information to identify unsafe medicines.

The swift arrest of the company’s proprietor signals a firmer stance by Indian authorities, but lasting change will require systemic reforms.

Key Points

Practical Advice

For Parents and Caregivers

• Check the label: Verify the manufacturer’s name, batch number, and expiry date before giving any medication to a child.
• Purchase from reputable sources: Use licensed pharmacies or verified online platforms that require a prescription.
• Report adverse reactions: If a child shows sudden vomiting, lethargy, or reduced urine output after taking a medication, seek medical help immediately and inform local health authorities.

For Healthcare Professionals

• Maintain vigilance: Keep an updated list of recalled medicines and share it with patients.
• Advocate for testing: Encourage hospitals to send suspicious batches to accredited labs for toxicology screening.
• Educate families: Explain the risks of unverified medicines and the importance of adherence to prescribed dosages.

For Industry Stakeholders

• Strengthen quality control: Implement routine DEG testing using gas chromatography‑mass spectrometry (GC‑MS) for all liquid formulations.
• Adopt digital traceability: Use blockchain or QR‑code systems to track each batch from raw material to final product.
• Collaborate with regulators: Participate in joint audits and share data on supply‑chain integrity.

Points of Caution

While the Coldrif case received extensive media coverage, not all Indian cough syrups are unsafe. However, consumers should remain alert to the following red flags:

• Unbranded or “home‑made” syrups sold in informal markets.
• Medicines lacking a batch number or manufacturing licence.
• Significantly lower price points compared to established brands, which may indicate compromised quality.

Ignoring these warning signs can increase the risk of exposure to toxic contaminants like DEG.

Comparison with Previous Incidents

India has faced several high‑profile pharmaceutical scandals in the past decade:

Gambia, Uzbekistan, and Cameroon Outbreaks (2023)

More than ten infant deaths were linked to Indian‑made cough syrups containing DEG. Those incidents prompted the Ministry of Health to tighten export‑testing protocols, but domestic oversight remained lax.

Ranbaxy Quality‑Control Scandal (2013)

The U.S. FDA banned several Ranbaxy products after finding falsified data and contamination. The case led to criminal charges against senior executives and a $500 million settlement.

Comparison Summary

Each episode reveals a pattern: inadequate raw‑material testing, gaps in regulatory enforcement, and delayed public alerts. The 2025 incident is the first to trigger a high‑profile arrest within India’s borders, suggesting a potential shift toward stricter accountability.

Legal Implications

The arrest of S. Ranganathan invokes several sections of the Indian Drugs and Cosmetics Act, 1940 and the Indian Penal Code (IPC):

• Section 18 of the Drugs and Cosmetics Act: Prohibits the manufacture of drugs that are adulterated or contain harmful substances.
• Section 269 of the IPC: Criminal negligence causing death.
• Section 275 of the IPC: Sale of noxious substances as food or drink.

Potential penalties include:

• Imprisonment of up to 10 years per count.
• Fines up to ₹10 crore (≈ $1.2 million) for each violation.
• Suspension or cancellation of the company’s manufacturing licence.

Additionally, the Food Safety and Standards Authority of India (FSSAI) may initiate parallel proceedings for consumer protection violations. Victims’ families can file civil suits for compensation under the Consumer Protection Act, 2019.

Conclusion

The Coldrif tragedy spotlights a critical intersection of public health, corporate responsibility, and regulatory oversight. While the swift arrest of the pharmaceutical owner marks a decisive step, lasting safety will depend on:

1. Robust, transparent testing of raw materials and finished products.
2. Consistent enforcement of existing drug‑safety laws across all Indian states.
3. Greater public awareness about how to verify medication authenticity.

Given India’s pivotal role as a global supplier of affordable medicines, the world watches closely. Strengthening India’s drug‑quality ecosystem will protect not only its own children but also millions of patients abroad who rely on Indian generics for life‑saving treatment.

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