TN unit, Pg1.

Key Highlights:

• A pharmaceutical unit on the outskirts of Chennai is under investigation for producing Coldrif Syrup, linked to 14 child deaths in Madhya Pradesh.
• The Tamil Nadu Drugs Control Department issued show-cause notices to the proprietor, Dr. G Ranganathan, and analytical chemist, K Maheshwari, citing violations of the Drugs and Cosmetics Act, 1940.
• The syrup sample was found to be adulterated with Diethylene Glycol (48.6% w/v), a poisonous substance, and misbranded for lacking a mandatory warning about usage in children below four years.
• Ranganathan previously directed Sresan Pharmaceutical Limited, which was struck off in 2009, and later obtained a manufacturing license for Sresan Pharmaceutical Manufacturer in 2011, valid until 2026.

Detailed Insights:

• The Tamil Nadu Drugs Control Department initiated action after receiving a letter from the Madhya Pradesh Food and Drug Administration regarding the deaths in Chhindwara.
• Inspectors found 264 violations at the unit, which operated with insufficient staff training and infrastructure, and had been previously red-flagged for quality issues with hand sanitizers during Covid.
• The company's core business included manufacturing drugs like promethazine, chlorpheniramine, astemizole, and cetirizine, used for allergies and cold symptoms, as well as preparations to improve haemoglobin levels.
• The show-cause notices demanded a recall of all stock, complete distribution records, and documents related to raw material purchases, including propylene glycol.

Key Concepts Involved:

• Adulteration: The process of making a substance impure by adding another, typically inferior, substance.
• Misbranding: The act of labeling a product with false or misleading information.
• Diethylene Glycol: A toxic alcohol used as a solvent, antifreeze, and humectant, dangerous if ingested.