M.P. and Kerala ban cough syrup brand; Centre starts inspection of pharma units in six States, Pg1

Key Highlights:

• The Union Health Ministry initiated risk-based inspections of 19 drug manufacturing units across six states after detecting diethylene glycol (DEG) in Coldrif cough syrup samples.
• Madhya Pradesh and Kerala banned the sale and distribution of Coldrif, manufactured by Sresan Pharmaceuticals, following reports of contamination.
• An investigation is ongoing into the deaths of at least 10 children potentially linked to contaminated cough syrups in Madhya Pradesh and Rajasthan.
• The Tamil Nadu Drugs Control Department ordered Sresan Pharmaceuticals to halt production after finding a batch of Coldrif to be "not of standard quality" and adulterated with DEG.

Detailed Insights:

• The Union Health Ministry initially ruled out the presence of DEG or ethylene glycol (EG) in syrup samples, based on tests conducted by the CDSCO.
• A multidisciplinary team is analyzing samples and investigating the cause of deaths in Chhindwara, Madhya Pradesh.
• DEG and EG are industrial solvents that can contaminate pharmaceutical ingredients due to poor oversight or the use of cheaper industrial-grade materials.
• The World Health Organization (WHO) has issued multiple global medical product alerts since October 2022 regarding over-the-counter medicines contaminated with DEG/EG, with an estimated 300 fatalities among children worldwide.
• The Madhya Pradesh government's order cited a test report from Tamil Nadu indicating that samples contained 48.6% of DEG, a poisonous substance.

Key Concepts Involved:

• Diethylene Glycol (DEG): A toxic industrial solvent that can contaminate pharmaceutical products.
• Ethylene Glycol (EG): Similar to DEG, a toxic industrial solvent used in various products.
• Adulteration: The process of making a product impure or lower in quality by adding foreign or inferior substances.