Cough syrup deaths: A year before tragedy, CAG warned Tamil Nadu of drug testing shortfalls

A year before the deaths of over 20 children in Madhya Pradesh’s Chhindwara district from contaminated cough syrup, the Comptroller and Auditor General of India (CAG) had already sounded the alarm on glaring lapses in Tamil Nadu’s drug regulatory system — the state where the fatal syrup was manufactured.

Between 2016-17 and 2020-21, Tamil Nadu’s drug inspectors consistently failed to meet targets, conducting only 61% of planned inspections and collecting barely half the required samples for quality testing, the CAG report revealed. Despite the warnings, systemic gaps in oversight and enforcement persisted — gaps that experts now say proved deadly.

In the aftermath of the Chhindwara tragedy, the prescribing doctor and three local drug inspectors were suspended, while the Centre ordered “risk-based inspections” at 19 pharmaceutical units across six states to identify regulatory weaknesses.

Sresan Pharmaceuticals, the Tamil Nadu-based manufacturer of Coldrif cough syrup linked to the deaths, received a show-cause notice for serious violations — but only after the Madhya Pradesh drug regulator pressed its southern counterpart to act. “Had the Tamil Nadu authorities enforced the CAG’s recommendations and tightened their inspection protocols, this tragedy might have been prevented,” a senior official said.

The CAG’s performance audit, submitted to the Tamil Nadu government on August 1, 2024, and tabled in the Assembly that December, painted a bleak picture of the state’s public health oversight.

From 2016 to 2021, drug inspectors repeatedly missed targets: in 2017-18, only 60,495 of the targeted 1,00,800 inspections were carried out — a 40% shortfall. Even in 2020-21, inspections lagged by nearly 38%.

The same pattern extended to sample collection. In 2020-21, for instance, just 8,604 of 18,816 required samples were tested — a 54% deficit.

Compounding the crisis was a severe manpower shortage: the drug control department operated with only 344 staff against a sanctioned strength of 488, leaving a 32% vacancy rate.

Officials warn these persistent failures are not isolated to one state. “Drugs manufactured in Tamil Nadu are distributed across India. Weak local oversight poses a national risk,” one official noted.

The revelations now sharpen the focus on regulatory accountability — and whether India’s drug safety framework can prevent another tragedy born not of negligence, but of warnings ignored.