CAG Flagged Tamil Nadu Drug Regulator’s Lapses Before MP Cough Syrup Deaths: Report

An official looks at bottles of the Coldrif cough syrup after a raid by the Drug and Pharmaceuticals Department officials in Jabalpur, Madhya Pradesh. (IMAGE: PTI)

The Comptroller and Auditor General of India (CAG) last year pointed out that Tamil Nadu’s drug regulator repeatedly fell short of its targets, with drug inspectors conducting only about 61% of scheduled inspections and collecting just 49% of required samples for quality testing between 2016-17 and 2020-21.

The shortcomings, which reflect poor monitoring and weak enforcement, came to the fore after 22 children died after consuming contaminated cough syrup in Madhya Pradesh’s Chhindwara district.

Officials told The Indian Express, which first reported the findings, that if Tamil Nadu’s drug inspectors had carried out regular inspections or acted on the CAG’s warnings, the tragedy might have been prevented.

The CAG data between 2016-17 and 2020-21 shows that drug inspectors consistently failed to meet their targets. The newspaper reported that the CAG sent a performance audit report to the Tamil Nadu government in August last year and it was tabled in the state assembly in December 2024.

The audit, which reviewed the state’s public health infrastructure, raised red flags about systemic weaknesses in the drug regulatory ecosystem and revealed gaps in Tamil Nadu’s inspection practices.

The data accessed by the newspaper paints a more damning picture and also shed light on a manpower crunch in the drug control department due to unfilled vacancies.

What The Numbers Say

Inspections: Between 2016-17 and 2020-21, drug inspectors consistently missed inspection targets across India.

• 2016-17: 66,331 of 1,00,800 inspections completed — 34% shortfall
• 2017-18: 60,495 of 1,00,800 — 40% shortfall
• 2018-19: 59,682 of 98,280 — 39% shortfall
• 2019-20: 62,275 of 1,03,500 — 40% shortfall
• 2020-21: 62,358 of 1,00,800 — 38% shortfall

Samples for testing:

• 2016-17: 9,561 of 17,280 — 45% shortfall
• 2017-18: 8,908 of 17,280 — 48% shortfall
• 2018-19: 8,988 of 19,656 — 54% shortfall
• 2019-20: 9,011 of 19,320 — 53% shortfall
• 2020-21: 8,604 of 18,816 — 54% shortfall

Manpower: Against a sanctioned strength of 488 posts, only 344 were filled — a 32% vacancy rate.

Officials said the shortfall poses a serious public health risk, not just for Tamil Nadu but nationally, since medicines manufactured and distributed in one state often reach multiple others.

Meanwhile, the Madhya Pradesh government has formed a Special Investigation Team (SIT) to probe the deaths and the owner of Sresan Pharmaceuticals, the manufacturer of Coldrif cough syrup, has been taken into police custody.