Context
The Union Health Ministry has launched extensive inspections of pharmaceutical manufacturing units across six States following the detection of diethylene glycol (DEG) in samples of the cough syrup Coldrif, produced by Sresan Pharmaceuticals. The move comes amid reports of multiple child deaths suspected to be linked to contaminated batches.
Key Developments
- State Bans:
- Madhya Pradesh and Kerala have banned the sale and distribution of Coldrif after lab tests confirmed DEG contamination.
- Tamil Nadu’s Drug Control Department ordered immediate suspension of production at Sresan Pharmaceuticals after finding a batch “not of standard quality.”
- Central Action:
- The Union Health Ministry initiated risk-based inspections at 19 drug manufacturing units in six States to verify compliance with quality norms.
- Investigations are ongoing in Chhindwara (Madhya Pradesh) and Rajasthan, where at least 10 child deaths have been linked to the cough syrup.
Toxicological Background
- Diethylene Glycol (DEG) and Ethylene Glycol (EG) are industrial solvents used in antifreeze and brake fluids.
- In pharmaceuticals, they can contaminate syrups when industrial-grade raw materials are used instead of pharmaceutical-grade ingredients.
- Both substances are highly toxic, damaging kidneys and the nervous system, and can be fatal to children.