Exclusive | Significant GMP Violations And Unhygienic Conditions Found At Sresan Pharma In Joint Inspection
During the joint inspection of the facility, 39 critical and 325 major deviations were identified, exposing significant non-compliance with Good Manufacturing Practices
Published : October 9, 2025 at 6:00 PM IST
Chennai: During a joint inspection by drug inspectors conducted at Ms. Sresan Pharmaceutical Manufacturer in Kancheepuram District, Tamil Nadu, a large number of non-compliances were found. The inspection report, accessed by ETV Bharat, recorded a total of 364 deviations, including 39 critical and 325 major deficiencies.
The company manufactured the Coldrif cough syrup (Chloropheniramine Maleate Syrup) linked to at least 22 children’s deaths in Madhya Pradesh.
The inspection findings report of the office of Director of Drugs Control, Tamil Nadu, highlighted critical gaps that pose significant risks to product quality and patient safety. Notable issues included the lack of adherence to Good Manufacturing Practices (GMP), unhygienic storage and manufacturing conditions, absence of validated testing methods, poor air handling unit functionality, inadequate personnel qualifications, and non-compliance with protocols related to sampling, cleaning, validation, and quality control.
The joint inspection was conducted by P Nithin Kumar, Senior Drugs Inspector Kancheepuram Zone and R Sasikumar, Drugs Inspector Thiruvallu Zone on October 3.
Specific critical deficiencies included the use of non-pharmaceutical grade raw materials, such as propylene glycol, in drug formulations without testing for toxic contaminants like diethylene glycol, which is a poisonous substance. The inspection also revealed poor environmental controls, with absence of proper air filtration systems, functional purified water systems, and pest control measures, leading to potential contamination risks.
Major deficiencies encompassed inadequate documentation practices, lack of process validation, insufficient training and hygiene protocols for staff, improper storage of raw materials and finished products, and ineffective recall and complaint handling systems.
The facility also exhibited improper storage and handling of raw materials and finished products, missing or incomplete documentation, and ineffective systems for complaint management, recalls, and quality reviews.
Due to these serious violations, the Deputy Director of Drugs Control has issued a stop production order for the manufacturing facility until further notice. A show-cause notice has also been issued to the manufacturer giving 10 days for explanation before any further punitive action, including potential license cancellation, is taken.
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