A shocking case in Chhindwara district, Madhya Pradesh, where over 14 children died due to cough syrup consumption, has stirred the nation. Amidst this, a 26-page report from the Tamil Nadu government on the Sresen Pharmaceutical factory has unveiled startling information.
An exclusive report acquired by India Today-Aaj Tak from the Tamil Nadu Drug Control Department's inspection revealed that syrups were being manufactured amid filth. There was a lack of skilled manpower, machinery, facilities, and equipment. The Quality Assurance Department was practically non-existent, and no checks were performed before batch release.
According to the report, severe negligence occurred in the production of 'Coldrif' cough syrup at Tamil Nadu's Sresen Pharmaceuticals, with 39 critical and 325 major lapses identified. The syrup contained 48.6% diethylene glycol (DEG), a known cause of kidney failure.
Plant Layout
The inspection revealed that 'Coldrif' syrup was being manufactured under unsanitary conditions. The factory lacked Air Handling Units (AHUs), had poor ventilation, and equipment was either damaged or rusted. The report stated that the plant's layout and design contributed significantly to the contamination risk.
Source: aajtak
The report indicated that the company purchased 50 kg of propylene glycol without an invoice, which is illegal. DEG traces, a highly toxic industrial solvent, were also found in the syrup, which is generally used in brake fluids, paint, and plastics.
While propylene glycol is a less harmful industrial solvent used in food, pharmaceuticals, and beauty products, diethylene glycol can be deadly to humans even in small amounts.
The substitution of propylene glycol with DEG is a well-known cause of toxicity incidents worldwide, including the recent child fatalities in Chhindwara, Madhya Pradesh.
Source: aajtak
Plastic Pipe Use in Formulation Transfer
Officials reported that the company used plastic pipes for liquid formulation transfer, had no filtration systems, and discharged chemical effluents directly into common drains.
The report further indicated, 'Critical manufacturing operations revealed water tanks in unhygienic conditions.'
The inspection team found that raw materials were released without testing or vendor approval, and there was no pharmacovigilance system to monitor adverse reactions. Sampling occurred in the open, making contamination inevitable.
Source: aajtak
No Pest Control Measures
The report highlighted a lack of arrangements to prevent insects or rodents. Fly catchers and air curtains were absent, and there was no provision for filtered air in production areas.
The report mentioned inadequate skilled manpower and that analytical test methods or cleaning processes had never been validated.
Following the inspection, the Tamil Nadu government banned the sale of Coldrif cough syrup throughout the state from October 1 and ordered the removal of all stock from the market.
'Production Halt Until Further Notice'
A senior official told the news agency PTI that samples taken from the factory later confirmed contamination. We have sought an explanation from the manufacturer. Production has been halted until further notice.
The revelations by the Tamil Nadu government indicate that, had the manufacturer adhered even to the most basic drug safety norms, this tragedy could have been averted.
In response, the Madhya Pradesh government suspended three officials and removed the state drug controller. Dr. Praveen Soni, who prescribed the syrup, was arrested and suspended. Additionally, the government announced a compensation of 4 lakh rupees for the families of the deceased. Several states, including Madhya Pradesh, Rajasthan, Kerala, and Tamil Nadu, have banned the sale of the syrup. The central government has initiated risk-based inspections of 19 drug units across 6 states.
