Cough syrup deaths: CAG report already flagged regulatory lapses in TN last year

While the death of 22 children in Madhya Pradesh after being administered contaminated cough syrup, manufactured by a Tamil Nadu company, has exposed major lapses in production, inspection, and testing of pharmaceutical products in the state, the Comptroller and Auditor General (CAG) had already flagged lapses by the state drug regulatory body last year.

The deaths pointed to the lack of adequate monitoring of drug samples and inadequate inspections by the Tamil Nadu Drugs Control Department in the state, while Sresan Pharmaceuticals, which manufactures Coldrif cough syrup, was found to be running for more than six years without maintenance and for 14 years without any inspection by drug control authorities.

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CAG flagged regulatory oversight

Even as the role of drug inspectors is under scrutiny in the wake of the deaths, a CAG report released last year highlighted significant shortfalls in the enforcement of drug inspections and sample testing in Tamil Nadu. It said inspection targets were unmet by 34-40 per cent annually, and sample lifting shortfalls ranged from 45-54 per cent. The shortfalls indicate challenges in regulatory oversight and quality control of pharmaceuticals.

The CAG performance audit of Tamil Nadu's public health infrastructure (covering 2016-2022) had pointed out underperformance in the Drugs Control Department, where manpower shortages were a major concern highlighted.

Vacancies ail regulatory body

With a staggering 32 per cent vacancy rate, the report stated that only 344 of 488 sanctioned posts were filled and the department struggled to meet basic mandates.

A former Drugs Administration Department official, on condition of anonymity, told The Federal that the vacancies impact the overall monitoring and regulatory functions of the department as the drug inspection targets are not met. “It is these issues that the CAG report had flagged, and they need to be considered now because there are several positions that need to be filled to ramp up sample lifting to full capacity."

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Shortfalls in facility checks, quality testing

The report also stated that the drug inspectors managed just 61 per cent of targeted drug facility checks on average, with shortfalls ballooning to 40 per cent in some years. Sample collection for quality testing was even poor, and could reach only 49 per cent of requirements—down to 46 per cent in 2018-19 and 2020-21. The report had urged immediate reforms, including improved staffing and infrastructure upgrades.

TN detected Coldrif’s toxicity: Health minister

The testing of Coldrif samples on time could have detected the toxic adulteration long before it claimed young lives, as the cough syrup was found laced with 45-48 per cent diethylene glycol (DEG), a highly toxic industrial solvent unfit for human consumption and exceeding safe limits by thousands of percent.

Responding to the criticism, state Health Minister Ma Subramanian said that we have taken immediate action after finding out about the lapses at the end of the Tamil Nadu government.

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“Even though lab reports by health officials from Madhya Pradesh and Union government officials stated that it was a safe medicine, it was the Tamil Nadu government that found that it was a highly toxic medicine. Details of this have also been sent to the states of Odisha and Puducherry so that other states are not affected," Subramanian said, while addressing the media on the sidelines of an event on Friday (October 10).

Subramanian shifts blame to AIADMK, Centre

He added that every year, a pharmaceutical export trade of Rs 12,000 crore to Rs 15,000 crore is being carried out from Tamil Nadu to about 100 countries. There are 397 pharmaceutical manufacturing companies in Tamil Nadu alone.

Hinting that the entire blame cannot be put on the DMK government, Subramanian said that the current problem is a large-scale issue and the leader of the Opposition, Edappadi K Palaniswam,i should also answer for the lapses mentioned in the CAG report from 2015 to 2021, during which his party was in power in Tamil Nadu.

Also read: Cough syrup deaths: TN govt not cooperating, it needs to take 'concrete steps', says MP CM Yadav

“The company Sresan Pharma has been given a notice that states that it has 10 days to respond or its license will be revoked. It is mandatory to conduct inspections at drug manufacturing facilities every year and the Union government's drug inspection team has not conducted any kind of inspection for the last three years. The state senior drug inspectors who did not inspect the drug in the past years have been dismissed, and departmental action will be taken," Subramanian added.