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healthysoch
New Delhi, June 26, 2020 :
There are many manufacturers of Active Pharmaceutical Ingredients (API) around the world, ensuring a large and diversified capacity of production for this product. So far, we have identified ten potentially quality approved suppliers from Asia, North America, and Europe.
Dexamethasone is an off-patent, common supportive treatment option and is generally affordable. WHO 2016 and 2019 surveys of different health facilities in low- and middle-income countries indicate that dexamethasone was available to patients at a median price of $0.33 per 4mg/ml injection ampoules (range: US$0.13-$3.5). Major UN procurers may be able to supply dexamethasone for a median price of $0.092 per 4mg/ml injection ampoule.
There are likely no restrictions, as dexamethasone is authorized worldwide.
There are 21 records of falsified dexamethasone in the WHO Global Surveillance and Monitoring System database with the most recent one received from the Eastern Mediterranean in February 2020.
It is expected that, following the high level of publicity given to the medicines, more reports will be received in the future. This is based on experience with chloroquine products when hydroxychloroquine was thought to be a potential treatment for COVID19
Increased vigilance throughout all supply chains and due diligence in any procurement activities are essential. Member States and regulatory authorities are encouraged to promptly report any incidents of substandard or falsified dexamethasone to the WHO global surveillance and monitoring system.
Work is ongoing to determine producers of licensed and quality assured products. Further assessments of additional production capacity will be undertaken.
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