Maldives Food and Drug Authority MFDA says importers of cold medicine (cough, cold, and fever medicine) must submit chemical analysis reports for the medicine before importing them into the Maldives.
This comes after the World Health Organization WHO alerted its member countries saying that large batches of liquid cold medicine in production since last October from several countries have been contaminated by chemicals diethylene glycol (DEG) and ethylene glycol (EG).
WHO stated that these contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.
As a cautionary measure to rule out such contaminations, MFDA said that a cold medicine from the approved list of medicines can also be imported into the Maldives if a chemical analysis of the medicine rules out DEG and EG contaminations.
MFDA said that it had reviewed the list of laboratories given approval to conduct such investigations to make the process easier for the importers.
The Authority said that the laboratory must be pre-qualified by WHO or be an accredited laboratory from a country included in FDA Reference Country Category 1. It further said that the laboratory can be an ISO 17025-certified laboratory and that the laboratory must not be owned by the company that produces the medicine being tested.
Yesterday MFDA banned the sale and use of 'Alergo Oral Liquid' (Cetrizine) as an MFDA random market sampling revealed that the medicine has been contaminated with DEG and EG. The medicine is manufactured by Pharmix Laboratorie of Pakistan.
