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Haryana firm flagged by WHO after 66 child deaths in Gambia stops making ‘contaminated’ syrups

After an inspection, the Haryana government finds 12 flaws in the manufacturing facility; ‘Action will be taken,’ says Home and Health Minister Anil Vij.

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New Delhi: The Haryana government has stopped the production of cough syrups by a Sonepat pharmaceutical company after the World Health Organisation (WHO) flagged the manufacturer, following the deaths of 66 children in The Gambia.

Haryana Home and Health Minister Anil Vij said Wednesday that samples of the cough syrups manufactured by Maiden Pharmaceuticals Limited have been sent to the Central Drug Laboratory in Kolkata. “The reports are not in yet. We shall take action after seeing them,” Vij said, as quoted by news agency ANI.

The minister added that 12 flaws had been found after the Central and Haryana State drugs departments jointly inspected the company’s manufacturing facility. “Keeping this in mind, it has been decided that total production should be stopped. A notice has also been issued to them,” Vij added.

The World Health Organisation last week issued an alert for four “contaminated” medicines manufactured by the Indian pharmaceutical company that were “potentially linked” with acute kidney injuries and 66 deaths among children in the tiny West African country.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters that the medicines were cough and cold syrups produced by Maiden Pharmaceuticals Limited. “WHO is conducting further investigation with the company and regulatory authorities in India,” he said, adding that the loss of young lives due to the products was “beyond heart-breaking for their families”.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The world health body said the manufacturer “to date has not provided guarantees to WHO on the safety and quality of these products”.

The WHO chief said while the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO has recommended that all countries detect and remove these products from circulation to prevent further harm to patients.

WHO said substandard medical products are those that fail to meet either their quality standards or specifications. Therefore, they are “out of specification”, the health body said.

Laboratory analysis of samples of each of the four products confirmed that they contain unacceptable amounts of contaminants diethylene glycol and ethylene glycol.

WHO said diethylene glycol and ethylene glycol are toxic to humans when consumed and could prove fatal.

“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” it said.

Medical officers in Gambia raised the alarm in July, after dozens of children fell ill with kidney problems. The deaths confounded medics before a pattern emerged: children younger than five were falling ill three to five days after taking a locally-sold paracetamol syrup.

Gambia’s director of health services, Mustapha Bittaye, said similar problems have been detected in other syrups but that the ministry was awaiting confirmation of the results.

He said the number of deaths has lessened in recent weeks and that the sale of products made by Maiden Pharmaceuticals was now banned. However, until recently, some of the syrups were still being sold in private clinics and in hospitals, he said.

According to its website, Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically as well as exporting them to countries in Asia, Africa and Latin America.

Also read: “Shocked to hear…” Maiden Pharma breaks silence on cough syrup deaths in Gambia


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