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The company’s presence has an intense concentration in Africa, including countries such as Algeria, Senegal, Nigeria, Cameroon, Kenya and Tanzania.
Digital Desk: The World Health Organization issued an alert on October 5, which came as a shocker to the Indian Pharmaceutical Industry, claiming that four cough syrups made by Maiden Pharmaceuticals Limited, based in Sonepat, Haryana, may have been ''contaminated'' and ''substandard'', which may have contributed to the deaths in the Gambia, a country in West Africa.
Anil Vij, the Health Minister of Haryana, announced that samples of the four cough syrups had been sent for testing to the Central Drugs Laboratory in Kolkata a day after the alarm.
Medical officers in Gambia raised the alarm in July after dozens of children began falling ill with kidney problems. The deaths confounded medics before a pattern emerged: dozens of patients 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 is awaiting confirmation of the results.
How did Maiden Pharma respond to WHO's allegations?
Breaking the silence on the controversy four days after WHO’s alert, Maiden Pharma said it has valid drug approvals for the export of the products in question and is not selling anything in the domestic market.
"We declare that we have afterward purchased the raw ingredients from certified and reputable companies," it continued.
According to the company, "We are shocked to hear the media reports regarding the deaths and deeply saddened by this incident, but we received the official information from our agent at the Gambia on October 5, 2022, and on the following date, a World Health Organization alert was issued against us."
Most of Maiden Pharmaceuticals' global operations are in South East Asia, South America, and Africa. According to its website, the company has two manufacturing facilities in Haryana, one in Kundli and the other in Panipat, as well as its corporate office in Pitampura, the National Capital. It claims to be a pharmaceutical company with WHO-GMP and ISO 9001-2015 certifications.
The company’s presence has an intense concentration in Africa, including countries such as Algeria, Senegal, Nigeria, Cameroon, Kenya and Tanzania.
In South East Asia, it has a presence in countries such as Laos, Vietnam, Thailand, Cambodia, the Philippines, Malaysia, and Indonesia, among others. The company’s footprints in South America include Ecuador, Chile, Venezuela, Surinam, and Paraguay, among others. It is also present in Russia, Poland and Belarus.
Experts flag missing links
The WHO’s recent alert linking cough syrups manufactured by an Indian pharmaceutical firm to the deaths of children in the Gambia is "alarming" and there are some missing links that need to be investigated an expert said on Saturday.
"There are, however, some missing links that need to be carefully ascertained and investigated," said Professor Y K Gupta, a senior pharmacologist and vice chairman of the Standing National Committee on Medicines (SNCM). Dr. Gupta said the first death suspected to be due to the same reason was noted in July.
He pointed out that the license for manufacture and sale was given by the state drug controller, and the company was licensed to export only to this one country and not to any other country or the Indian domestic market.
The other missing link is that of the 23 samples that WHO tested, ethylene glycol was found in only four samples, Dr. Gupta said, adding, "This is perplexing and needs clarification."
"Also, the importing country gets it tested as per defined standards or their pharmacopeia. It seems this was somehow missed," he added.
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