Posted on October 11, 2025
Following a tragic event in which several children died after ingesting tainted cough syrup, India’s central drug authority has shifted much of the burden to a regulatory failure in Tamil Nadu. Government officials said that multiple failures on the part of the Tamil Nadu drug control officials allowed the manufacturer to continue to operate without any oversight, effectively resulting in what officials call a health public health scandal.
The syrup Coldrif, manufactured by Sresan Pharmaceuticals, Kancheepuram, Tamil Nadu, has been connected to the deaths of more than 20 children in Madhya Pradesh. Tests also found that it contained diethylene glycol (DEG), a toxic industrial solvent, at 48.6 percent, which far exceeds the permissible limit of 0.1 percent. The revelation prompted urgent investigations into how such a gross violation could go unnoticed.
According to insiders, the Central Drugs Standard Control Organisation (CDSCO) has claimed that the state regulatory authority, Tamil Nadu Food and Drug Administration (TN-FDA), failed in serious regulatory negligence. It is alleged that the state regulatory authority did not register the manufacturer under the Sugam portal which is a database to stream line all drug manufacturers into a common regulatory registry did not enforce mandatory inspections, and did not communicate with the central agency about important issues resulting from its audits.
As one central anonymous official stated, “because CDSCO did not participate in any of the inspections at Sresan Pharma this company was not included in any of the CDSCO databases.” The central authorities claim that when they subsequently attempted to conduct a joint audit with the Tamil Nadu inspectors, the state inspectors did not attend, despite requests. As a result, the CDSCO had to carry out inspections independently and subsequently recommend license suspension and criminal actions.
The results of the recent inspections revealed a disturbing picture of the Sresan facility: there were more than 350 violations, including unsanitary conditions and rusting equipment, and potentially using non-pharma-grade chemicals. In addition, it was reported that Sresan did not comply with WHO-GMP norms or the modifications to Schedule M, and in view of the several reminders for the necessary upgrades, Sresan has still not made an application for upgrades that are constitutionally required.
Tamil Nadu officials have defended their response at the same time. They said inspections of the unit occurred until the year 2022, and in 2021-22, they had imposed penalties for violations. Health Minister Ma Subramanian said the state would send a formal reply to the central government’s allegations. Two drug inspectors in Kancheepuram have reportedly been suspended for failing to inspect the unit in recent years.
In Madya Pradesh, the Chief Minister, Mohan Yadav, has made a public announcement blaming Tamil Nadu’s regulatory apparatus, accusing it of failing to take timely action and sampling of the syrup at the source. He said that the disciplinary steps have already been taken against the state drug controllers and inspectors at MP, and the owner of the manufacturing company has been taken into custody.
The controversy has highlighted larger concerns about oversight of the pharmaceutical industry in India. The central regulator stated that inspections of a number of drugmakers discovered serious shortcomings in testing both raw material and finished product – many companies apparently manufactured product without testing each batch, as is mandated by regulation. In response, CDSCO has issued directives to all state drug controllers to tighten enforcement, especially for excipient and ingredient checks.
As the inquiry develops, the next question is whether criminal liability will be found, and how state and federal agencies might work to shore up confidence in the regulatory system. This case reveals tensions in health regulation autonomy, existing at the state level while equally reinforcing the primacy of coordinated national oversight at the same time. It raises uncomfortable questions about accountability and safety in the pharmaceutical supply chain.