Dr. Praveen Soni- The pediatrician who is alleged to have allegedly accused of writing contaminated phlegm syrup causing the death of 14 children- the Madhya Pradesh government has suspended the license of a medical store owned by a member of his family. The Madhya Pradesh government is now investigating why such a large consignment of contaminated phlegm syrup reached Parasia in Chhindwara district. More than 600 contaminated phlegm syrup were sent from Jabalpur to Chhindwara, and one of them left for Parasia.
On the other hand, the Medical Association of India (IMA) has defended a doctor arrested in connection with the deaths due to cough syrup in Madhya Pradesh, saying that the approval of the syrup and its quality monitoring comes completely under the purview of the drug regulatory system. The IMA said in a statement on Monday that the Central Drug Standards Control Organization (CDSCO) and the Madhya Pradesh Food and Drug Administration in the case failed to monitor the concentrations of DEG (Diathylene Glycol) in Cuff Syrup.
The 26-page report of the Tamil Nadu government, specially obtained by India Today TV, revealed severe violations and unstable practices at Srison Pharmaceutical in Kanchipuram, whose phlegm syrup ‘Coldriff’ has been linked to 14 children in Madhya Pradesh and two in Rajasthan.
In the inspection conducted by the Tamil Nadu Drug Control Department, more than 350 flaws were found in the construction process. The authorities classified the violations into ‘severe’ and ‘major’, and concluded that the firm lacked basic features, qualified employees and proper procedures to ensure product safety.
Dirty campus, lack of quality check
Inspectors reported that Coldrif Cuff Syrup was being constructed under unclear conditions, with no air handling units (AHUs), poor ventilation, and equipment was damaged or rusty. The report states that the layout and design of the plant only contributes to the risk of contamination.
The quality assurance department was not present, and no authorized person was appointed to monitor the batch release. There was no standard operation process (SOP) to recall products or deal with quality deficiencies.
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“The company has not provided no gowning process, GMP drain, pure water system, insect control or cleaning system,” the report said. The products were reportedly stored in corridors and places where AHUs were not working, making them in contact with dust and cross-polls.
Use of non-pharma grade chemicals
In one of the most shocking conclusions, the report showed that the company had bought a 50 kg propilin glycol without a challan, indicating illegal purchase. It also found excerpts from the diathylene glycol (DEG) in the syrup, a highly toxic industrial solvent that is often used in brake fluid, paint and plastic.
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Propilein glycol is a relatively safe industrial solvent used in food and cosmetics, but dietyline glycol is also fatal to humans even in small amounts. The use of DEG instead of propilin glycol is a known cause of large -scale incidents of toxicity worldwide, including recent deaths of children in Chhindwara, Madhya Pradesh.
Officials found that the company used plastic pipes to move liquid formulation, there was no filtration system, and pump chemical wastes directly into normal drains. The report further states, “Pure water tanks used in important manufacturing works were found in unhealthy positions.”
The inspection team found that the raw material was released without testing or seller permission, and no pharmacovizlance system was present to monitor adverse reactions. The samples were taken in an open environment, making the contamination unavoidable.The report said, “There were no measures to prevent the entry of pests or rodents. Fly catcher and air layer were missing. There was no ventilation of air filtered in production areas.”There was also a shortage of skilled employees in the company and major quality checks including analytical testing methods and verification of cleaning processes were never done.
Government action
After inspection, the Tamil Nadu government banned the sale of cuff syrup Coldriff across the state from 1 October and ordered the removal of all existing stocks from the market. A senior official told news agency PTI that adulteration was later confirmed in samples collected from the plant.“We have sought an explanation from the manufacturer. The plant has been stopped in the plant till further orders,” the official said.
A nationwide alert has been issued after the death of children in Chhindwara. Several states including Madhya Pradesh, Rajasthan and Tamil Nadu have now banned the sale and use of Coldriff Syrup till further investigation.
In Madhya Pradesh, the state government has suspended three officers and transferred the State Drug Controller, as the deaths were linked with contaminated phlegm syrup in initial reports.
The findings of the Tamil Nadu government now show that if the manufacturer had followed the most basic drug safety criteria, this tragedy could have been stopped.