At least 22 children have died in India this month after consuming a contaminated cough syrup found to contain nearly 45% diethylene glycol (DEG), a toxic industrial solvent used in brake fluid and antifreeze. The concentration is hundreds of times above the permissible limit of 0.1% set by pharmacopeial safety standards.

The syrup, branded Coldrif, was manufactured by Sresan Pharmaceuticals in Tamil Nadu and distributed across several districts of Madhya Pradesh. Laboratory tests confirmed the dangerously high DEG levels. 

Following the deaths, authorities arrested the company’s owner, sealed the factory, and ordered an immediate recall of all implicated batches.

While these steps suggest swift action, the tragedy is far from an isolated event. It fits a recurring pattern of deadly contamination in India’s pharmaceutical industry, one that has repeatedly exposed significant regulatory gaps and a culture of neglect that allows such disasters to keep unfolding.

The cough syrup market was worth 262.5m in 2024, and has been predicted to grow to $743m by 2035, growing at by 9.9% each year, according to Market Research Future.

Driving this consumption is both the lack of doctors, particularly in rural areas, which drives people to over-the-counter remedies. In addition, high levels of air pollution in many areas cause children to cough – something that cannot be solved by cough syrup.

Pattern of deaths

The deaths in Madhya Pradesh echo earlier incidents that have shaken global confidence in Indian drug exports. In 2022, nearly 70 children in The Gambia and 18 in Uzbekistan died after consuming contaminated syrups manufactured by Indian firms.

In Uzbekistan, the victims had taken Dok-1 Max, produced by Marion Biotech, a Noida-based manufacturer. Tests revealed that the syrup contained ethylene glycol (EG), a poisonous chemical used in industrial antifreeze. 

A few months earlier, a similar tragedy unfolded in The Gambia. The World Health Organization (WHO) linked dozens of Gambian children’s deaths to four syrups made by another Indian company, Maiden Pharmaceuticals Ltd. 

“Laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” according to the WHO.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death.”

A health expert based in Delhi told Health Policy Watch, on condition of anonymity, that such incidents are not surprising: “To understand why this keeps happening, you have to look at where and how these medicines are actually made – and what rules are being ignored.” 

Factory of filth and neglect

That warning proved eerily accurate in the case of Sresan Pharmaceuticals, the company behind Coldrif. 

A recent Indian Express investigation described a scene of chaotic abandonment inside the factory: “Stacked plastic jars, stained concrete floors, hoses still snaking across the ground. Windows closed tight, some blocked with makeshift barriers.” 

Through a narrow opening, reporters saw “piles of white and blue containers leaning against the walls, black buckets on the floor, and discarded labels charred in the backyard.”

In the ashes outside, investigators found half-burnt labels of Pronic Iron Syrup and Cyproheptadine Hydrochloride Syrup IP — products also manufactured by Sresan. The site, the report said, reeked of hurried abandonment, as if workers had fled in panic.

An India Today report from Kanchipuram, where the factory operated, revealed over 350 violations, including rusted machinery, unhygienic conditions, and the absence of mandatory quality testing. 

These findings paint a grim picture of how, without proper regulation, some life-saving drugs are brewed in conditions closer to workshops than laboratories.

India’s weak oversight

India’s Central Drugs Standard Control Organisation (CDSCO) is responsible for the oversight of new drugs, imports, clinical trials, and setting national standards. 

It falls under the Union Health Ministry, and licenses large manufacturers and handles export approvals.

Under CDSCO’s oversight, there are six zonal offices, four sub-zonal offices, and a network of central drug testing laboratories.

However, according to the Indian Drugs & Cosmetics Act, 1940, the regulation of the manufacture, sale and distribution of most drugs is a mandate of state drug controllers. The states are also responsible for licensing, market sampling, and post-market surveillance. 

State drug controllers oversee thousands of small and medium-scale manufacturers,  including firms like Sresan Pharmaceuticals that produce drugs for local markets.

But this dual regulatory model has serious cracks, and two authorities that rarely work in sync.

The CDSCO has acknowledged that state labs and regulatory bodies frequently lack capacity, both in terms of trained personnel and infrastructure to carry out rigorous testing for impurities or enforce license compliance. 

As the state authorities hold many of the licensing powers, these gaps in state enforcement often turn into systemic fatal oversights.

A 2024  inspection drive led by CDSCO and state drug controllers checked over 400 premises, including many medicine manufacturers. 

The drive found widespread non-compliance: a large fraction of units were issued show-cause notices, suspended, or shut down for failing to meet GMP and other safety standards. 

“There must be coordination between the Centre and the state agency. We can’t play the blame game,” said Ishtiyaq Wani, editor of a local health news outlet, speaking to Health Policy Watch. “India is one of the largest drug exporters to low-income countries, but unless both regulators act jointly, such tragedies will keep repeating.

Cheap illegal substitutes 

Most cough syrup contamination originates from substandard or illegal raw materials. Pharmaceutical-grade solvents such as glycerin and propylene glycol, the standard base in syrup medicines, must meet strict purity standards. 

Cheaper industrial-grade substitutes, including diethylene glycol or ethylene glycol, are sometimes used illegally as substitutes because they cost less than half the price. Such shortcuts have repeatedly led to child deaths in both domestic and international markets.

Each time a crisis erupts, officials promise reform. But even after global embarrassment over the Gambia and Uzbekistan tragedies, India’s domestic safeguards remain barely changed.

State regulators, meant to be the first line of defense, often lack accredited testing labs, qualified inspectors, and digital systems to track batches. The result is predictable: contaminated drugs slip through until lives are lost.

“The system responds only after people die,” said a retired scientist  who spoke on condition of anonymity. “Once the media leaves, the checks fade again.”

Without a coordinated surveillance network between the central and state authorities, accountability simply dissolves. Factories are shuttered for a few months, then quietly reopen under new names or owners.

A crisis of confidence

India’s drug industry built its global reputation by supplying affordable medicines to the developing world. But repeated incidents of fatal contamination are eroding that trust. In countries from Gambia to Indonesia, authorities demand independent testing of Indian exports before distribution. 

At home, families of victims are left with little recourse. Few cases ever result in a conviction. Compensation is rare, and company directors often vanish into bureaucratic loopholes.

The problem, health economists warn, is not a lack of rules but their uneven enforcement. “The law is strong on paper,” said one public health lawyer in Bengaluru. “But when state regulators are underfunded and overburdened, even the best laws mean little.”

In the aftermath of the Coldriff tragedy, experts have again called for tighter oversight — a unified drug safety authority, routine supplier audits, and real-time data sharing between states and the CDSCO. But unless these proposals move beyond press conferences, little will change.

For now, the pattern remains painfully familiar: a deadly batch, public outrage, temporary bans – then silence and inaction until the next tragedy.

India’s pharmaceutical industry is still the “pharmacy of the Global South,” but each new contamination weakens that claim. Behind every bottle of syrup, there’s a fragile chain of trust. And each time that chain breaks, it costs more than reputation — it costs children’s lives.

Image Credits: WHO, CDSCO.