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Search resuls for: "Medicines Control Agency"


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[1/2] Logo of the Maiden Pharmaceuticals Ltd. company is seen on a board outside their office in New Delhi, India, October 6, 2022. REUTERS/Anushree Fadnavis/File PhotoCompanies Maiden Pharmaceutical Ltd FollowBANJUL, July 21 (Reuters) - Gambia's government is "far advanced" in exploring avenues for potential legal action against Indian drugmaker Maiden Pharmaceuticals and a local distributor over toxic cough syrups believed to have killed dozens of children, it said on Friday. The small West African country has hired a U.S. law firm to explore legal action, the justice minister previously told Reuters. The Indian drugmaker Maiden Pharmaceuticals has denied wrongdoing, and the Indian government says that tests it conducted on the drugs showed they were not contaminated. The World Health Organization said last year that the India-made cough syrups contained lethal toxins ethylene glycol and diethylene glycol – commonly used in car brake fluid and other products not fit for human consumption.
Persons: Anushree, syrups, Pap, Nellie Peyton, Louise Heavens, Matthew Lewis Organizations: Maiden Pharmaceuticals Ltd, REUTERS, Maiden Pharmaceutical, Indian, Pharmaceuticals, Medicines Control Agency, MCA, Reuters, Atlantic Pharmaceuticals, Government of, World Health Organization, World Bank, Thomson Locations: New Delhi, India, BANJUL, Gambia, Government of India, Banjul
Three Gambian lawyers said this is the highest profile case of its kind against the nation's health ministry and the drug regulator, as well as against Maiden itself. It adds that the regulator and the health ministry failed to ensure that drugs were prescribed "with the expected standard of care." Gambia's health ministry did not respond to requests for comment. By this stage, the Gambian health ministry had sent samples of the Maiden syrups abroad for testing. The drugs regulator, the Medicines Control Agency, which is part of the health ministry, did not respond to a request for comment for this story.
Persons: syrups, Maiden, vomited, Amie Jammeh, Mafugi Jassey, Mafugi, Jammeh, Loubna Farage, Jude Nwokike, Markieu Janneh Kaira, Kaira, Edward McAllister, Michele Gershberg, Sara Ledwith Organizations: Suit, Reuters, World Health Organization, WHO, Pharmaceuticals, EG, World Bank, Medicines, Pharmacopeia, Medicines Control Agency, Thomson Locations: Serekunda, Gambia, India, DAKAR, Indonesia, Uzbekistan, Senegal, Africa
The new rule highlights how governments are reassessing their reliance on India's $42 billion pharmaceutical industry since the contamination came to light last year. India's industry supplies nearly half of the pharmaceuticals used in Africa. In April, India’s government said its officials had held meetings in Africa to ensure its drug exports did not suffer after at least 70 children died in Gambia after ingesting the cough syrup last year. "Quntrol shall conduct document verification, physical inspection of the consignment and sampling, for laboratory testing for each shipment," the letter said. Since June 1, India has made tests mandatory for all cough syrups before they are exported.
Persons: India’s, Janneh Kaira, Rajeev Singh Raghuvanshi, Raghuvanshi, Krishna N, Aurora Ellis Organizations: Reuters, Medicines Control Agency, MCA, Quntrol Laboratories, Bank, World Health Organization, Thomson Locations: DELHI, Gambia, India, Africa, Mumbai
The World Health Organization said last year the syrups, made by Indian manufacturer Maiden Pharmaceuticals Ltd, contained lethal toxins ethylene glycol (EG) and diethylene glycol (DEG) – used in car brake fluid. "If you ask and you don't get informed, it's a dead end," Rutendo Kuwana, the WHO's team lead for incidents with substandard and falsified medicines, told Reuters in an interview on March 31. Drug inspectors found a dozen violations at Maiden last October related to the production of the cough syrups sold to Gambia, a government document showed. Among these, some of the COAs of raw ingredients used in making the syrups, including propylene glycol, were missing batch numbers. Kuwana said the WHO was sure of its own cough syrup test results from two separate independent laboratories, both of which showed contamination.
BANJUL, Oct 31 (Reuters) - Gambia has not yet confirmed that toxic cough syrup was the cause of the deaths of 70 children from acute kidney injury, a representative of the country's Medicines Control Agency said on Monday. The small West African state has been investigating a mysterious slew of child deaths in recent months, which police said in a preliminary investigation was linked to four cough syrups made in India. The spike in cases of acute kidney injury among children under the age of five was detected in late July. By October, the number of deaths had risen to 70, out of 82 children reported to have acute kidney injury. Indonesia has also recorded a spike in child deaths from acute kidney injury in recent months, and is investigating paracetamol syrups as a possible cause.
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