Coldrif Syrup Tragedy Exposes India’s Deepening Drug Safety Crisis
At least 22 children have died in India this month after consuming a contaminated cough medicine, triggering renewed scrutiny of the country’s drug safety system and regulatory oversight. Laboratory tests found the syrup contained nearly 45% diethylene glycol (DEG), a highly toxic industrial chemical commonly used in antifreeze and brake fluid. The permitted limit under pharmacopeial standards is just 0.1%.
The product, marketed as Coldrif Syrup, was manufactured by Sresan Pharmaceuticals, a Tamil Nadu–based company, and distributed across multiple districts of Madhya Pradesh. Health authorities confirmed that the DEG concentration was hundreds of times above safe limits, making the medicine lethal rather than therapeutic.
Following the deaths, regulators arrested the company’s owner, sealed the manufacturing unit, and ordered an immediate recall of all affected batches. While these actions signal urgency, experts warn that the incident is part of a much larger and unresolved pattern of pharmaceutical failures in India.
A fast-growing market, weak safeguards
India’s cough syrup market was valued at about $262.5 million in 2024 and is projected to grow rapidly over the next decade, driven by over-the-counter sales and limited access to doctors in rural areas. Air pollution in many regions also contributes to widespread coughing among children, prompting parents to rely on readily available syrups despite limited medical guidance.
Public health specialists note that cough syrups are often misused as quick fixes for symptoms caused by pollution or viral infections, conditions that such medicines cannot cure. High demand combined with lax monitoring creates fertile ground for substandard and dangerous products to enter the market.
A familiar and deadly pattern
The Madhya Pradesh deaths echo earlier tragedies that severely damaged global confidence in Indian-made medicines. In 2022, nearly 70 children died in The Gambia and 18 in Uzbekistan after consuming contaminated syrups produced by Indian manufacturers. In those cases, tests detected diethylene glycol and ethylene glycol, both toxic chemicals never meant for human consumption.
The World Health Organization later confirmed that the affected products contained “unacceptable amounts” of these contaminants and warned that exposure can cause vomiting, kidney failure, altered mental states, and death.
Health experts say the latest case follows the same script. One Delhi-based specialist, speaking anonymously, explained that the problem lies not just in isolated negligence but in how medicines are manufactured and regulated at the ground level.
Inside the Sresan Pharmaceuticals factory
Investigations into the facilities operated by Sresan Pharmaceuticals paint a disturbing picture. Reports from Indian media described abandoned production areas with stained floors, rusted machinery, blocked windows, and discarded labels. Inspectors reportedly found signs of hurried shutdowns, half-burnt packaging, and a lack of basic hygiene expected in pharmaceutical manufacturing.
An official inspection in Kanchipuram district identified more than 350 violations, including the absence of mandatory quality tests and severely unhygienic conditions. These findings highlight how life-saving drugs can be produced in environments closer to informal workshops than regulated laboratories.
Regulatory gaps at the core
India’s drug oversight system is split between central and state authorities. The Central Drugs Standard Control Organisation (CDSCO) sets national standards and oversees large manufacturers and exports, while state drug controllers handle licensing, inspections, and surveillance for most domestic producers.
This dual structure often results in poor coordination. State regulators, who oversee thousands of small and medium manufacturers like Sresan Pharmaceuticals, frequently lack trained inspectors, modern testing labs, and digital tracking systems. CDSCO itself has acknowledged these capacity gaps, warning that weak state enforcement can quickly become systemic failure.
A nationwide inspection drive in 2024 found widespread non-compliance with Good Manufacturing Practices, leading to closures and suspensions. Yet critics argue that enforcement remains reactive rather than preventive.
The danger of cheap substitutes
Most contamination cases stem from the use of industrial-grade solvents in place of pharmaceutical-grade ingredients. Glycerin and propylene glycol, essential bases for syrups, are expensive when produced to medical standards. Cheaper alternatives like DEG cost far less and are sometimes illegally substituted, with fatal consequences.
Despite repeated disasters and international criticism, experts say domestic safeguards have barely improved. Factories may shut temporarily, only to reopen under new names, while accountability remains elusive.
A growing crisis of trust
India has long been known as the “pharmacy of the Global South,” supplying affordable medicines worldwide. But repeated contamination incidents are eroding that reputation. Several countries now demand independent testing of Indian drug imports before distribution.
At home, families of victims face long legal battles, limited compensation, and few convictions. Public health lawyers emphasize that India’s laws are robust on paper but ineffective without consistent enforcement and adequate funding for regulators.
What comes next?
In the aftermath of the Coldrif Syrup tragedy, experts are once again calling for reforms: a unified drug safety authority, routine audits of raw material suppliers, real-time data sharing between states, and stronger penalties for violations.
Until such measures move beyond announcements, the cycle is likely to repeat. Each contaminated batch sparks outrage, followed by brief crackdowns and eventual silence.
Behind every bottle of medicine lies a chain of trust. When that chain breaks, the cost is not just reputational damage, but young lives lost to failures that were entirely preventable.
