Amid Cough Syrup Deaths, Big Reveal In Centre's 2024 Audit On Drug Testing
Major revelations have been made over the reality of drug tests amid a probe into the deaths of nearly two dozen children after consuming adulterated cough syrup. The Comptroller and Auditor General of India (CAG) had last year flagged a shortfall in drug tests in Tamil Nadu, pointing to a serious negligence by the drug authorities.
The renewed focus on drug testing follows the death of 23 children in Madhya Pradesh. The deaths are linked to the Coldrif syrup manufactured by Sresan Pharmaceuticals, a Tamil Nadu-based company.
What CAG Said In 2024
The CAG's performance audit on the public health infrastructure and management of health services, tabled on December 10, 2024, had flagged shortages in reaching the targets for drug inspection and lifting of samples.
In 2016-17, the target for total inspections to be carried out in Tamil Nadu was 1,00,800. But only 66,331 inspections were carried out, reflecting a 34% shortfall. Three years later, in 2020-21, the shortfall in targeted inspection of drugs increased to 38%. During this period, 1,00,800 inspections were to be done, but only 62,358 were carried out.
Between 2016 and 2021, the highest shortfall was noted at 40% during 2019-20.
The CAG also flagged shortfalls in the lifting of drugs for testing by drug inspectors. During the above period, the deficit was noted at 54% in 2018-19 and 2020-21.
Drug inspections are a critical step in the pharma production process that aims to ensure the quality of drugs and prevent adulteration. The inspections are carried out by drug inspectors. The medicines make their way to the retail shops and clinics only after their clearance.
Toxic Substance In Coldrif
Samples of Coldrif, a drug prescribed to treat symptoms of cold and cough in children, were declared adulterated by Tamil Nadu authorities earlier this month after it was found to contain diethylene glycol (DEG). DEG is a poisonous substance used in the manufacture of printing ink and glue that could cause severe kidney, liver, and nervous system damage in humans.
An inspection later found unbilled containers of DEG at Sresan's Kancheepuram factory, and that the firm was adding 46-48% of DEG to the Coldrif cough syrup against the permitted limit of only 0.1%.
The Tamil Nadu Drugs Control Authority had then issued a stop-production order and frozen all its stocks. The company's license was also suspended.
Sresan Pharma's owner, Ranganathan Govindan, has now been arrested.
Madhya Pradesh Blames Tamil Nadu
Madhya Pradesh Chief Minister Mohan Yadav has blamed the Tamil Nadu government for the deaths of over 23 children in his state, describing it as a failure of regulatory vigilance and timely action. "The deaths have happened due to manufacturing defects of the cough syrup, which was being made at the factory in Tamil Nadu. So, timely action and sampling should first have been initiated there," he said.
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