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☆ Gambia 'advanced' in exploring legal action over toxic Indian cough syrup
▼ + stars: | 2023-07-21 | by ( Pap Saine | ) www.reuters.com time to read: +2 min

[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

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.

☆ As African kids died, doctors fought for ban on toxic Indian syrup
▼ + stars: | 2023-03-10 | by ( ) www.reuters.com time to read: +5 min

Maiden Managing Director Naresh Kumar Goyal told Reuters he had "not done anything wrong" and did not respond to further questions. In December, India’s health regulator said it did its own tests and found no toxins in the syrups. Yet even as the doctors’ evidence of toxins mounted, Gambian government officials told Reuters they wanted more proof. “We took their histories and asked them if they took the drugs, and we just knew” that the syrup was the culprit. If tests for toxins had been done in late July or early August, a sales ban could have saved dozens of children, she said.

☆ FDA says no indication contaminated cough syrups have entered U.S. supply chain
▼ + stars: | 2023-03-03 | by ( ) www.reuters.com time to read: +1 min

March 3 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday there was no indication that contaminated cough and paracetamol syrups that caused deaths of children in Gambia last year have entered the U.S. drug supply chain. This comes after an investigation led by the U.S. Center for Disease Control and Prevention and Gambian scientists reported on Thursday that these medicines contaminated with toxic levels of diethylene and ethylene glycol led to acute kidney injury among 78 children in Gambia. "We will continue to monitor the situation and keep the public and health care professionals updated of any changes in status to the U.S. market," Patrizia Cavazzoni, director for FDA's Center for Drug Evaluation and Research, said in a tweet. In October, the World Health Organization sent out an alert saying four cough syrups containing toxic levels of diethylene and ethylene glycol made by India's Maiden Pharmaceuticals Ltd should be withdrawn. Reporting by Mariam Sunny in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.

☆ US CDC concludes cough syrups likely to blame for children's deaths in Gambia -report
▼ + stars: | 2023-03-02 | by ( Jennifer Rigby | ) www.reuters.com time to read: +2 min

The links between the children's deaths and contaminated medicines first came to light in October, when the World Health Organization sent out an alert saying four cough syrups made by India's Maiden Pharmaceuticals Ltd contained toxic levels of diethylene and ethylene glycol and should be withdrawn. The new investigation "strongly suggests" that medicines contaminated with the toxins, imported into Gambia, led to the cluster of acute kidney injury among 78 children. Maiden has denied its drugs were at fault for the deaths in Gambia, and the Indian government has said the syrups showed no contamination when it tested them. "This likely poisoning event highlights the potential public health risks posed by the inadequate quality management of pharmaceutical exports," the report said. Since the deaths in Gambia, 201 children have also died in Indonesia, and 19 in Uzbekistan, linked to different manufacturers' contaminated cough syrups.

☆ Indian maker of cough syrup linked to Uzbekistan deaths halts production
▼ + stars: | 2022-12-30 | by ( ) www.reuters.com time to read: +2 min

NEW DELHI, Dec 30 (Reuters) - The Indian maker of a cough syrup that was linked to the death of 19 children in Uzbekistan said on Friday that it had halted production of all medicines after an inspection by the drug regulator. Indian media reported that the inspectors had found deviation from rules on manufacturing at one of Marion Biotech's units. Uzbekistan's health ministry said at least 18 children died in Samarkand city after consuming Marion Biotech's Dok-1 Max syrup. Hasan Harris, Marion Biotech's legal head, told Reuters partner ANI, "We await the reports, the factory was inspected. The Uzbekistan case follows deaths of at least 70 children in Gambia that had been linked to cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals Ltd.

☆ Indian maker of syrup linked to Uzbekistan deaths halts production; facility inspected
▼ + stars: | 2022-12-29 | by ( ) www.reuters.com time to read: +2 min

REUTERS/Anushree FadnavisNEW DELHI, Dec 29 (Reuters) - India's drug regulator said on Thursday that it had inspected Marion Biotech's production facility and promised more action based on the probe report after the company's cough syrup was linked to death of 18 children in Uzbekistan. A legal representative of Marion Biotech said the Indian maker of pharmaceuticals and cosmetics regretted the deaths and the company has halted production of the Dok-1 Max syrup. The drug regulator reviewed the company's Noida facility in the Uttar Pradesh state and is in regular touch with its Uzbekistan counterpart, the Indian health ministry said in a statement. "The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing," the ministry said. Uzbekistan's health ministry said on Wednesday that at least 18 children in the country died after consuming the syrup, manufactured by the Indian drugmaker.

☆ Uzbekistan says 18 children die after consuming India-made syrup
▼ + stars: | 2022-12-28 | by ( ) www.reuters.com time to read: +2 min

NEW DELHI, Dec 28 (Reuters) - Uzbekistan's health ministry has said at least 18 children have died after consuming a medicinal syrup manufactured by Indian drugmaker Marion Biotech Pvt Ltd. The ministry said 18 out of 21 children who took the Doc-1 Max syrup while suffering from an acute respiratory disease died after consuming it. The syrup was imported into Uzbekistan by Quramax Medical LLC, the ministry said in its statement released on Tuesday. An Indian government source said the health ministry was looking into the matter. The Uzbek health ministry said it had dismissed seven employees for negligence for not analysing the deaths in a timely manner and not taking the necessary measures.

☆ India inspects drug factories as Gambia controversy lingers
▼ + stars: | 2022-12-27 | by ( ) www.reuters.com time to read: +2 min

India is known as the "pharmacy of the world" and its pharmaceuticals exports have more than doubled over the past decade to $24.5 billion in the past fiscal year. The deaths of at least 70 children in Gambia has dented the industry's image, though India says the drugs made by New Delhi-based Maiden Pharmaceuticals Ltd were not at fault. "Joint inspections are being conducted all over the country as per standard operating procedures," the Ministry of Health and Family Welfare said in a statement. Some health experts say India's drug regulations are lax, especially at the level of states where thousands of factories operate. But India's main drugs officer told the World Health Organization this month that tests of samples from the same batches of syrups that Maiden sent to Gambia were compliant with government specifications.

☆ Maiden Pharma hopes to reopen plant as Indian lab clears syrups suspected by WHO in Gambia deaths
▼ + stars: | 2022-12-16 | by ( Krishna N. Das | ) www.reuters.com time to read: +2 min

I have not done anything wrong," Maiden Managing Director Naresh Kumar Goyal told Reuters. "We will now try to request the authorities to reopen the factory. Somani, said that tests on samples of Maiden's products had "been found to be complying with specifications" and no ethylene glycol or diethylene glycol was detected in them. A spokesperson for India's health ministry did not respond to a request for comment. The tests were carried out by the state-run Regional Drug Testing Laboratory in the northern city of Chandigarh, the government said earlier.

☆ Gambia says it has not yet confirmed cough syrup as cause of child deaths
▼ + stars: | 2022-10-31 | by ( Pap Saine | ) www.reuters.com time to read: +2 min

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.

☆ Indonesia finds some medicines with ingredients linked to fatal child kidney injury
▼ + stars: | 2022-10-20 | by ( ) www.reuters.com time to read: +1 min

JAKARTA, Oct 20 (Reuters) - Some medicinal syrups available in Indonesia contained ingredients linked to fatal acute kidney injury (AKI) in children, its health minister said on Thursday, as it investigates a spike in cases and 99 child deaths this year. Indonesia has temporarily banned sales of all syrup-based medications and has been looking closely at paracetamol syrups used locally to treat fever in children that contain diethylene glycol and ethylene glycol. Gambia's government is also investigating child AKI deaths linked to paracetamol syrups after 70 fatalities there. As of Thursday, Indonesia has identified 206 AKI child cases of which 99 were fatalities this year. A health ministry spokesperson declined to say in how many child AKI patients the ingredients were detected, citing the ongoing investigation.

☆ Indonesia says 74 children have died from acute kidney injury this year
▼ + stars: | 2022-10-19 | by ( ) www.reuters.com time to read: +2 min

JAKARTA, Oct 19 (Reuters) - More than 70 children in Indonesia have died from acute kidney injury (AKI) since January this year, a health ministry official said on Wednesday, as a team of experts investigates the spike in cases. The development comes as health officials in Gambia said nearly 70 children had died from AKI after taking a locally sold paracetamol syrup used to treat fever. Health ministry official Siti Nadia Tarmizi said the ministry had identified 189 cases of AKI among Indonesian children, most aged under five years old, with 74 fatalities recorded since January. The health ministry has said it is talking to experts from the WHO that are investigating the cases in Gambia. The health ministry is expected to provide further details later on Wednesday.

☆ Gambia says child deaths linked to cough syrup have risen to 70
▼ + stars: | 2022-10-14 | by ( ) www.reuters.com time to read: +1 min

BANJUL, Oct 14 (Reuters) - Gambia's government on Friday said the number of child deaths from acute kidney injury, thought to be linked to Indian-made cough syrups, has risen to 70 from a previous toll of 69. President Adama Barrow gave the update at an emergency cabinet meeting which he convened on Thursday to discuss the crisis, according to a presidency statement. The syrups were found to be made by New Delhi-based Maiden Pharmaceuticals Ltd, which has since had one of its factories shut down in northern India as health authorities there investigate. Gambia is also investigating the deaths and this week set up a new commission of inquiry to deal with them, the statement said. Register now for FREE unlimited access to Reuters.com RegisterReporting by Pap Saine; Writing by Nellie Peyton; Editing by Chris ReeseOur Standards: The Thomson Reuters Trust Principles.

☆ India tells Gambia it is probing childrens' deaths linked to India-made drugs
▼ + stars: | 2022-10-13 | by ( ) www.reuters.com time to read: +2 min

Logo of the Maiden Pharmaceuticals Ltd. company is seen on a board outside their office in New Delhi, India, October 6, 2022. The matter "is being seriously investigated by appropriate authorities," India's foreign minister S Jaishankar said in a tweet. Known as a "pharmacy of the world", India supplies 45% of all generic medicines to Africa. The WHO issued a medical product alert last week asking regulators to remove Maiden goods from the market. The U.N. health agency said that laboratory analysis of four Maiden products - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - had "unacceptable" amounts of diethylene glycol and ethylene glycol, which can be toxic and cause acute kidney injury.

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