India directed drug manufacturers to stop using propylene glycol sourced from the Delhi-based firm that supplied the ingredient to Marion Biotech, whose cough syrups were linked to deaths of 19 children in Uzbekistan, according to a government document seen by Reuters.
The European Commission (EC) has taken an European Union-wide legally binding decision and confirmed the favorable benefit/risk profile of ambroxol and bromhexine containing medicines. This decision follows the opinion of the Coordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh) as well as the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within the European Medicines Agency (EMA).
Ambroxol and Bromhexine Expectorants: Safety Information to Be Updated