The World Health Organisation (WHO) has raised a warning on two cough syrups manufactured by Uttar Pradesh-based Marion Biotech Pvt Ltd, which were considered as the cause of death of 18 children in Uzbekistan.
The two products are DOK-1 Max syrup and Ambronol syrup. To date, the manufacturer, Marion Biotech, has not furnished guarantees to WHO on the safety and quality of the implicated products.
Laboratory examination of specimens of both products, undertaken by national quality control laboratories under the Ministry of Health, Republic of Uzbekistan, found both products to be contaminated with unacceptable amounts of diethylene glycol and /or ethylene glycol.
Ethylene glycol and Diethylene glycol are harmful to humans when consumed and can be fatal.
National regulatory authorities/health authorities were suggested to instantly report to WHO on discovering these substandard products in their respective country.
The Indian drug regulator has directed the firm to stop all manufacturing activities after conducting an inspection. Pharmexcil, India's export promotion council, has also immediately suspended the company's membership.
Copyright © 2021 Institute of Good Manufacturing Practices India ( IGMPI® All Rights Reserved. Trademarks are the property of the owner )