“Inside the Factory Behind Deadly Cough Syrup: Hundreds of Safety Violations”

A 26-page Tamil Nadu government report, obtained exclusively WNS TV, has uncovered serious violations and unhygienic practices at Kancheepuram-based Sresan Pharmaceutical.

Whose cough syrup Coldrif has been linked to the deaths of 14 children in Madhya Pradesh and two in Rajasthan.

The Tamil Nadu Drugs Control Department’s inspection identified over 350 lapses in the manufacturing process, classifying them as ‘critical’ and ‘major’. The report concluded that the company lacked basic facilities, qualified staff, and proper procedures to ensure product safety.

Filthy Premises and Lack of Quality Checks

Inspectors reported that Coldrif was manufactured in unhygienic conditions, with poor ventilation, no air handling units (AHUs), and damaged or rusted equipment. The plant’s layout increased contamination risks. The company had no Quality Assurance department, no designated authority for batch release, and no standard procedures for recalls or quality failures.

The report also highlighted the absence of proper gowning procedures, pest control, cleaning mechanisms, GMP-compliant drains, and purified water systems. Products were stored in corridors where AHUs were non-functional, exposing them to dust and cross-contamination.

Use of Non-Pharma Grade Chemicals

Alarmingly, the company purchased 50 kg of propylene glycol without invoices, suggesting illegal procurement. Traces of diethylene glycol (DEG)—a highly toxic industrial solvent—were found in the syrup. DEG, often used in brake fluids and plastics, is lethal even in small quantities and has caused similar mass poisoning incidents worldwide.

Additionally, the company used plastic pipes for liquid transfer, lacked filtration systems, and discharged chemical effluents into general drains. Purified water tanks were reportedly unhygienic, and raw materials were released without testing or vendor approval.

Lapses Across Production Stages

The inspection revealed no measures to prevent rodent or insect entry, missing fly catchers and air curtains, and unventilated production areas. Major quality checks, including validation of analytical methods and cleaning procedures, were never performed, and no pharmacovigilance system existed to track adverse reactions.

Government Crackdown

Following the inspection, the Tamil Nadu government banned the sale of Coldrif from October 1 and ordered all existing stock removed. Samples confirmed adulteration, prompting production to be halted pending the manufacturer’s explanation.

The deaths in Chhindwara have triggered a nationwide alert, with Madhya Pradesh, Rajasthan, and Tamil Nadu halting Coldrif sales. In Madhya Pradesh, three officials were suspended, and the state drug controller transferred after preliminary reports linked the fatalities to the syrup.

The findings indicate that the tragedy could have been prevented had the manufacturer adhered to basic drug safety norms.