National Drug Authority Breaks Silence On Deadly Cough Syrups Linked To The Death Of 66 Children

National Drug Authority Breaks Silence On Deadly Cough Syrups Linked To The Death Of 66 Children

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By Spy Uganda

The National Drug Authority (NDA) has cleared the air on deadly cough syrups linked to the death of 66 children in Gambia saying they are not authorised for sale and use in Uganda.

 “NDA provides assurance to the public that the affected products are not available on the Ugandan market. NDA has never approved nor authorised the sale of any products from Maiden Pharmaceuticals Limited (Haryana, India),” NDA said in a statement.

NDA further noted that to ensure safety, they also verify and inspect drugs for importation at ports of entry as well as post-market surveillance.

”Inspection and licensing of pharmacies and drug shops through the regional offices and Testing of medicines and medical devices in NDA WHO accredited and 1SO 17025 certified laboratories at Mulago.

”After granting market authorisation, NDA further undertakes post-market surveillance that includes risk-based sampling and testing of medicines on the market; investigate drug-related complaints and also address any adverse drug reaction events regarding medicines through Pharmacovigilance.”

According to World Health Organization (WHO) laboratory analysis, the affected syrups including; Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip NCold Syrup contain unacceptable amounts of Diethylene Glycol and Ethylene Glycol as contaminants which are toxic to humans when consumed and can be fatal.

WHO further added that the toxic effect “can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”

On Wednesday last week, WHO Issued a health alert over the four cough and cold syrups made by Maiden Pharmaceuticals in India “have been potentially linked with acute kidney injuries and 66 deaths among children”.

The UN health agency also cautioned the contaminated medications may have been distributed outside of the West African country, with global exposure “possible”.

WHO chief Tedros Adhanom Ghebreyesus expressed concern saying ”the loss of these young lives is beyond heartbreaking for their families.”

Tedros added that WHO was also “conducting further investigation with the company and regulatory authorities in India.”

WHO said information received from India’s Central Drugs Standard Control Organisation indicated that the manufacturer had only supplied the contaminated medications to The Gambia.

“However, the supply of these products through informal or unregulated markets to other countries in Africa, cannot be ruled out,” WHO added.

“In addition, the manufacturer may have used the same contaminated material in other products and distributed them locally or exported,” it warned.

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