Officials seal Coldrif cough syrup bottles in Chhindwara, MP, on Sunday. (ANI)
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Between 2016-17 and 2020-21, the drug regulator in Tamil Nadu consistently fell short of its targets, with inspectors conducting about 61% of scheduled drug inspections and collecting roughly 49% of the samples required for quality testing.
These persistent shortfalls — which lay bare structural weaknesses in monitoring and enforcement, and are in focus following the death of 22 children after drinking contaminated cough syrup in Madhya Pradesh’s Chhindwara district — were red-flagged by the Comptroller and Auditor General of India last year.
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The Centre has also directed “risk-based inspections” to be carried out in 19 manufacturing units across six states to identify gaps and strengthen quality assurance mechanisms.
Sresan Pharmaceuticals, the manufacturer of the Coldrif cough syrup linked to the deaths, has been issued a show-cause notice accusing it of grave violations, but only after the Madhya Pradesh drug regulator wrote to its Tamil Nadu counterpart requesting action.
Had Tamil Nadu regulators conducted regular inspections and acted on the CAG report, this tragic incident could have been averted, officials say.
On August 1, 2024, the CAG sent a performance audit report to the Tamil Nadu government. The report, which examined the state’s public health infrastructure, was tabled in the state Assembly on December 10, 2024 and covered the performance audit for the period 2016-2022. It red-flagged a series of deficiencies, including weaknesses in the drug regulatory ecosystem, and presented scathing data on the state’s drug inspections.
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According to the CAG data, between 2016-17 and 2020-21, drug inspectors consistently fell short of targets: in 2016-17, only 66,331 of the 1,00,800 inspections targeted were conducted, a shortfall of 34%; in 2017-18, 60,495 inspections were conducted against a target of 1,00,800, leaving a 40% gap; in 2018-19, 59,682 inspections were conducted from 98,280 targeted, a 39% shortfall; in 2019-20, 62,275 inspections were conducted out of 1,03,500 targeted, leaving a 40% gap;
and in 2020-21, 62,358 inspections were conducted against a target of 1,00,800, resulting in a 38% shortfall.
In the same period, drug inspectors also fell short of targets for collecting samples for testing.
In 2016-17, only 9,561 of the 17,280 samples that were to be lifted were collected, a shortfall of 45%; in 2017-18, 8,908 samples were lifted against a target of 17,280, leaving a 48% gap; in 2018-19, 8,988 samples were collected from 19,656 targeted, a 54% shortfall; in 2019-20, 9,011 samples were lifted out of 19,320 targeted, leaving a 53% gap; and in 2020-21, 8,604 samples were collected against a target of 18,816, resulting in a 54% shortfall.
The report also flagged the manpower shortage being faced by the drug control department, which likely exacerbated the issue: against the sanctioned strength of 488, the working strength was 344 — a 32% vacancy.
According to officials, these numbers point to public health implications, not just for
Tamil Nadu but nationally, since drugs are distributed across multiple states.
Kaunain Sheriff M is an award-winning investigative journalist and the National Health Editor at The Indian Express. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, an investigation into one of the world’s most powerful pharmaceutical companies.
With over a decade of experience, Kaunain brings deep expertise in three areas of investigative journalism: law, health, and data. He currently leads The Indian Express newsroom’s in-depth coverage of health.
His work has earned some of the most prestigious honours in journalism, including the Ramnath Goenka Award for Excellence in Journalism, the Society of Publishers in Asia (SOPA) Award, and the Mumbai Press Club’s Red Ink Award.
Kaunain has also collaborated on major global investigations. He was part of the Implant Files project with the International Consortium of Investigative Journalists (ICIJ), which exposed malpractices in the medical device industry across the world. He also contributed to an international investigation that uncovered how a Chinese big-data firm was monitoring thousands of prominent Indian individuals and institutions in real time.
Over the years, he has reported on several high-profile criminal trials, including the Hashimpura massacre, the 2G spectrum scam, and the coal block allocation case. Within The Indian Express, he has been honoured three times with the Indian Express Excellence Award for his investigations—on the anti-Sikh riots, the Vyapam exam scam, and the abuse of the National Security Act in Uttar Pradesh. ... Read More
