Inspections at the Sresan Pharmaceuticals facility in Kanchipuram have uncovered 364 critical and major violations including leaking equipment, rust, use of non-pharma materials, lack of pest control, and unsafe storage practices in the same plant tied to child fatalities from toxic cough syrup.
Glimpse:
Tamil Nadu drug inspectors found that the Coldrif manufacturing plant operated under deeply unsafe conditions, identifying 364 violations across all phases of production. From cracked and leaking equipment to use of industrial-grade raw materials without invoices, the findings shed light on how routine quality norms were breached raising serious questions about regulatory oversight and corporate responsibility.
A recent inspection by Tamil Nadu’s Drugs Control Department revealed 364 critical and major violations at the Sresan Pharmaceuticals plant in Kanchipuram, where the controversial Coldrif cough syrup is manufactured.
Inspectors documented severe deficiencies throughout the facility: corroded, cracked, and leaking equipment, absence of functioning air handling units, no purified water systems, and missing pest control mechanisms.
Many production and labeling operations were done in ill-ventilated zones without adherence to cleanliness protocols.
Perhaps most alarming was the report that the firm procured non-pharmaceutical grade propylene glycol without invoices, bypassing standard vendor traceability.
Inspectors also identified diethylene glycol (DEG) contamination in the syrup batch under scrutiny, a known lethal industrial solvent.
Raw materials were released for use without proper testing or vendor approvals. The plant lacked a functional Quality Assurance department, SOPs for recalls, or any pharmacovigilance system to track adverse reactions.
The facility had reportedly been operating under such conditions for years, despite licensing since 2011. State drug inspectors had not flagged these concerns until recently.
In response, the Kanchipuram plant has been sealed. Show-cause notices have been issued to the company, and law enforcement agencies including a Special Investigation Team (SIT)have been involved.
This case underscores how systemic regulatory failures and lax manufacturing discipline can lead to tragedies demanding urgent reforms across pharmaceutical compliance and oversight.
“When production becomes a gamble and safety a forgotten clause, every batch risks becoming a threat.”
By
HB Team
