An investigative report reveals serious lapses at the Sresan Pharma facility in Kanchipuram filthy production conditions, lack of quality checks, unqualified personnel, and use of non-pharma grade solvents linked to toxic cough syrup deaths in Madhya Pradesh and Rajasthan.
Glimpse:
A Tamil Nadu inspection found over 350 violations at the Sresan Pharma plant making Coldrif syrup, including use of industrial grade solvents, non-functioning ventilation, rusted equipment, absent quality assurance, and unhygienic manufacturing practices. One batch (SR-13) was found to have nearly 48% diethylene glycol (DEG), far exceeding safe limits, and has been declared “Not of Standard Quality.” The facility has been sealed and the license suspended pending further probe.
An exhaustive ground inspection by Tamil Nadu regulatory authorities has uncovered alarming failures at Sresan Pharmaceutical, the Kancheepuram plant manufacturing Coldrif cough syrup implicated in recent child deaths due to kidney failure. The findings suggest not just isolated errors, but a systemic breakdown of drug safety protocols.
Major Findings & Violations
The facility was operating with no proper ventilation or functional air handling units (AHUs), with rusted and damaged equipment.
Hygiene was severely neglected
Storage of raw materials and finished products in corridors, production areas exposed to dust, pest infestation, no pest control mechanisms.
Absence of basic quality-assurance infrastructure: no authorised personnel for batch release, lack of standard operating procedures (SOPs), no system for product recalls or adverse event tracking.
Regulatory & Human Impact
Batch SR-13 (May 2025, expires April 2027) of Coldrif was tested and found heavily contaminated.
As many as 16 children in Madhya Pradesh have died after consuming syrup from this batch others in Rajasthan. Many children developed acute kidney failure.
The state government has sealed the facility, suspended its production, and revoked or suspended relevant licenses pending further investigation. Show-cause notices have been issued.
Systemic Lapses Triggering the Crisis
Inspector oversight had reportedly been minimal or absent for years, despite mandatory regulatory requirements.
Qualified staff and essential technical checks were missing; raw inputs were not tested for impurities, suggesting weak procurement audits.
“This is not just about one rogue batch it’s about what happens when regulatory oversight is decayed, corners are cut, and basic pharmaceutical integrity is ignored.
By
HB Team
