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<ul><li>Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference. </li><li>It is a practice that the importing country tests the products for quality before sanctioning their usage there.</li><li>Four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated.</li></ul> A probe has been initiated by India's drug regulator after the <keyword id="6366244" type="General" weightage="20" keywordseo="who" source="Orion">WHO</keyword> issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The <keyword id="162357" type="General" weightage="20" keywordseo="Gambia" source="Orion">Gambia</keyword>, official sources said. The World Health Organisation (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by <keyword id="15173890" type="General" weightage="20" keywordseo="Maiden-Pharmaceuticals-Limited" source="Orion">Maiden Pharmaceuticals Limited</keyword> based in Haryana's Sonepat could be the reason for the deaths in the West African nation. The sources said the exact "one-to-one causal relation of death" has neither been provided by the <keyword id="10118578" type="General" weightage="20" keywordseo="United-Nations-Health-Agency" source="Orion">United Nations Health Agency</keyword> nor the details of labels and products been shared by it with the <keyword id="170943" type="General" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organisation" source="Orion">Central Drugs Standard Control Organisation</keyword> (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products. "Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana. "While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," the sources said. According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia. It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested. The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority. A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained. From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products. "The company has manufactured and exported these products only to The Gambia so far," the source said. It is a practice that the importing country tests the products for quality before sanctioning their usage there. As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India. "At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products," the official source stated. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/indias-service-sector-activity-falls-to-6-month-low-in-sep-amid-inflation-competition-pmi/articleshow/94675187.cms">India's service sector activity falls to 6-month low in Sep amid inflation, competition: PMI</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/taj-mahal-will-be-open-for-night-viewing-during-sharad-purnima-for-four-nights/articleshow/94672935.cms">Taj Mahal will be open for night viewing during 'Sharad Purnima' for four nights</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/rupee-falls-4-paise-to-81-66-against-us-dollar-in-early-trade/articleshow/94672726.cms">Rupee falls 4 paise to 81.66 against US dollar in early trade</a>

Indian drug regulator kicks off probe on cough syrup linked to deaths of Gambian children

<ul class="summary-list"><li>Seventy children died in Gambia, and their deaths have been linked to contaminated cough syrup.</li><li>The victims' families were offered a combined $20,000 in compensation, or about $285 per victim.</li></ul>The families of 70 deceased Gambian children — whose deaths are believed to be linked to consuming cough syrup imported from India — were offered a combined $20,000 in compensation, the <a href="https://www.bbc.com/news/live/world-africa-62845587?ns_mchannel=social&amp;ns_source=twitter&amp;ns_campaign=bbc_live&amp;ns_linkname=6368ecce49d9ef23494b98d0%26Gambia%20families%20reject%20%2420%2C000%20for%20cough%20syrup%20deaths%262022-11-07T13%3A11%3A28.704Z&amp;ns_fee=0&amp;pinned_post_locator=urn:asset:87309ef4-be69-4711-b51a-c36e5a3062ee&amp;pinned_post_asset_id=6368ecce49d9ef23494b98d0&amp;pinned_post_type=share">BBC</a> reported. This amounts to about $285 per victim.Ebrima Sanyang, the chairperson of the grieving families, told the BBC the money was "an insult to the victims," and the families have rejected the offer. Taking the money would mean that they were not fighting for justice for their children, he said.The West African state is probing a slew of child deaths that have occurred over the past months, Adama Barrow, the president of Gambia, said in a <a href="https://www.op.gov.gm/sites/default/files/articles/H.E%20Statement%20-%20ACUTE%20KIDNEY%20INJURY%20OUTBREAK%20100922.pdf">statement</a> in early October.Beginning in July, the country's Ministry of Health "detected an unusual rise in the number of cases of diarrhea and vomiting among children under the age of five," Barrow said. Many of those children would go on to develop Acute Kidney Injuries, or AKI's, that resulted in their deaths.Preliminary investigations indicate that the deaths are linked to the consumption of four cough syrups that were made in India, the Gambian police said in a report in mid-October, per <a href="https://www.reuters.com/world/africa/gambia-police-link-child-deaths-cough-syrup-imported-by-us-firm-2022-10-11/">Reuters</a>.The World Health Organization, or WHO, is working with the Gambian government in the investigation. The organization issued a <a href="https://www.who.int/news/item/05-10-2022-medical-product-alert-n-6-2022-substandard-(contaminated)-paediatric-medicines">health alert</a> after it found the four cough products contain "unacceptable amounts of diethylene glycol and ethylene glycol as contaminants."According to the WHO statement, consumption of diethylene glycol and ethylene glycol can prove fatal. Effects include abdominal pain, vomiting, diarrhea, and "acute kidney injury which may lead to death."The organization listed India-based company Maiden Pharmaceuticals Limited as the manufacturer. Maiden Pharmaceuticals did not immediately respond to Insider's request for comment.The Ministry of Health and Family Welfare in India released a <a href="https://pib.gov.in/PressReleasePage.aspx?PRID=1865655">statement</a> saying that while the four drugs Maiden Pharmaceuticals produced "are not licensed for manufacture and sale in India," the company has permission to manufacture them "for export only."Since October, 41,500 out of 50,000 bottles of contaminated cough syrup have been recalled, but the rest are still unaccounted for, the Gambian police told <a href="https://www.nytimes.com/2022/11/03/world/asia/india-gambia-cough-syrup.html">The New York Times</a> in early November.The country's Medicines Control Agency — a national regulatory institution — has not been able to definitively conclude that the cough syrups were the culprit, Tijan Jallow, an official, said at a news conference on October 31, per <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/gambia-says-it-has-not-yet-confirmed-cough-syrup-cause-child-deaths-2022-10-31/">Reuters</a>. The country is still in the process of trying to establish what each child took, he added. The Medicines Control Agency and the Gambian police did not immediately respond to Insider's requests for comment.

Gambia offered $285 to the families of 70 children whose deaths have been linked to contaminated cough syrup. The families say the offer is 'an insult to the victims.'

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Indian drug regulator kicks off probe on cough syrup linked to deaths of Gambian children

PTI

Gambia offered $285 to the families of 70 children whose deaths have been linked to contaminated cough syrup. The families say the offer is 'an insult to the victims.'

Amanda Goh

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