An Indian drug manufacturer is under fire after the death of more than 60 very young patients in The Gambia. The children are said to have all taken a cough syrup from Maiden Pharmaceuticals, according to Gambian authorities, who have been investigating the deaths for more than a month. The company, Maiden Pharmaceuticals, announced an internal investigation and was also visited by Indian government auditors over the weekend. According to Indian media, Maiden may lose the export permission.
Last week, the World Health Organization (WHO) sent a international warning from. The cough medicines Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup contain lab tested, the harmful substances diethylene glycol and ethylene glycol. These ingredients can cause severe kidney damage and symptoms, especially in children: “abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental status and acute kidney injury that can lead to death,” the warning reads. Countries are advised to have the medicines removed from the shops.
Kidney problems in toddlers
The cough syrups were circulating in The Gambia, where health authorities and doctors raised the alarm in July about a sharp rise in cases of kidney problems in young children. In that month, several dozen patients were known – many under five years old – who did not survive the complaints. 66 children have now died in the West African country. Because of the “unacceptable” content of the harmful ingredient, the WHO states that the cough medicines are “potentially linked” to the acute cases.
In The Gambia, where doctors and relatives had already sought the media before, parents were already advised not to use the medicines anymore. Since then, the number of severe kidney complaints in young children has decreased drastically. Aid workers go door-to-door in some cities to empty family medicine cabinets. Police are involved in an investigation into the deaths.
The WHO announced in the warning that it has still not received guarantees from the manufacturer to substantiate safety and quality control of the medicines.
Generic drugs
The four drugs were only exported from India to The Gambia, according to both Indian authorities and the manufacturer. The WHO is concerned that the cough syrup has been resold from that country, for example through informal traders.
Manufacturer Maiden Pharmaceuticals said in a statement this weekend “shocked by the media reports” and “sad” about the dead. However, the company is said to have only been made aware of the problems with the cough syrup by partners in The Gambia after last week’s WHO warning.
Maiden is based in the northern Indian state of Haryana. The Indian pharmaceutical sector is growing rapidly and is one of the largest worldwide. Many manufacturers focus on the production of generic and therefore cheaper medicines that can be sold internationally. For example, the discredited company states that it “an international presence” has in Africa, South and Central America and Asia.
Also complaints in India
Certain criteria apply to exports. It is unclear where in the chain this supervision has fallen short of the four poisonous syrups. Both the company and the authorities did not respond to questions asked about it. Including the publications India Today and Economic Times to make A number of recent problems surrounding the manufacturer on Saturday: Maiden also appears to have been criticized several times in his own country, in the states of Bihar, Gujarat and Kerala, for supplying batches of bad medicines. Vietnam even blacklisted the company for several years for failing to provide quality control. In Indian media, therefore, questions are now not only being asked about the actions of Maiden Pharmaceuticals, but also about the role and possible negligencefrom the regulator, Drugs Controller General of India.
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