The cough remedies Regulatory Scrutiny has intensified globally following tragic incidents of contamination, particularly involving the pediatric segment. Contamination with toxic industrial solvents like Diethylene Glycol (DEG) and Ethylene Glycol (EG) has been linked to numerous child fatalities in multiple countries, severely impacting consumer confidence and the reputation of the global pharmaceutical industry. This crisis has exposed significant regulatory gaps, especially concerning the quality control of raw materials and domestic manufacturing standards.
In response, regulatory bodies worldwide are enforcing much stricter Good Manufacturing Practices (GMP) and mandatory testing protocols, requiring manufacturers to rigorously screen for DEG/EG in excipients used in liquid formulations. These mandates necessitate substantial investment in quality control infrastructure and are pushing manufacturers to comply with global safety standards, even for domestic sales. The increased oversight marks a permanent shift towards heightened accountability and safety in the production and distribution of cough syrups.
Related Reports