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Uzbekistan deaths: Marion Biotech asked to halt production of all drugs due to deviations from rules

healthcare | Dec 29, 2022 4:26 PM IST

Uzbekistan deaths: Marion Biotech asked to halt production of all drugs due to deviations from rules

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Uzbekistan deaths: The central and state drug regulatory authorities conducted a joint inspection of Marion Biotech on December 27. The second inspection was conducted on Thursday. Here's what the government and the World Health Authorities said on the incident.

Under scanner over deaths of 18 children in Uzbekistan, Marion Biotech has been asked to stop all productions at its manufacturing facility in Noida, Union Health Minister Mansukh Mandaviya said on Friday. "...in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday (December 29) night, while further investigation is ongoing."

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Citing reason for this halt,  sources told CNBTV-18, "Drug regulatory authorities from central and state governments found deviations from rules and regulations on manufacturing practices."
After conducting inspections, the Uttar Pradesh government has sought a reply from the company over these "deviations". Sources said, "The records weren't produced by Marion Biotech. (Therefore,) drug regulators have sought details of all documents." Meanwhile, the production has been stopped till test reports of the collected samples of cough syrup, allegedly responsible for 18 deaths, are received.
Hasan Harris, the legal representative of the company, said on Thursday Marion Biotech has stopped manufacturing cough syrup that allegedly led to the death of 18 children in Uzbekistan, . "The production has been stopped and samples have been collected...We regret the deaths and the probe is on...We will act as per the report, whenever it comes," he said.
Drug regulatory bodies conduct inspection
The central and state drug regulatory authorities conducted a joint inspection of Marion Biotech on December 27. They collected some samples for analysis. Now, the Uttar Pradesh Drug Regulatory Authority is awaiting reports from the central government to take further action.
The second inspection of Marion Biotech was held on Thursday. "Centre and state officials visited the office of Marion Biotech to collect some information," said government sources. Authorities carried out a minute inspection of the company's records.
It is suspected that the Uttar Pradesh may consider suspending the license or production of cough syrups depending on the inspection and reports of the central government.
Indian health ministry sources said earlier the cough syrup under question is not sold in India.
Marion Biotech has been manufacturing cough syrups since 2012. It "is a licensed manufacturer and holds licence for manufacturing of Dok1 Max syrup and Tablet for export purpose granted by Drugs Controller, Uttar Pradesh", the government said.
The certificate accessed by CNBC-TV18 showed that Uttar Pradesh authority had issued a licence to the company. The certificate was labelled to be valid up to October 2021.
What happened in Uzbekistan?
Uzbekistan has claimed that 18 children died in the country after consuming medicines manufactured by Noida-based Marion Biotech. As per reports on a local Uzbek news website, the Uzbek government said that 21 kids were hospitalised with acute respiratory diseases. It was said to be a side-effect of consuming the cough syrup Dok-One Max, which Marion Biotech allegedly manufactures. Eighteen of these children have died.
According to the Uzbek health ministry, primary laboratory studies showed the presence of ethylene glycol in the syrup. Ethylene glycol is toxic and found in industrial-grade glycerine which should not be used in pharmaceutical products. Uzbekistan's statement said the tablets and syrups being marketed under the Dok-One brand have since been withdrawn from sale in all pharmacies in the country.
The statement further said the children who died took between 2.5 and 5 millilitres of the cough syrup at home for three to four times a day, which was higher than the standard dose of the drug.
How Indian govt responded?
The government responded to the claims, saying, "...the Central Drugs Standard Control Organisation (CDSCO) is in regular contact with the national drug regulator of Uzbekistan regarding the matter...". It further informed that "samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing".
Meanwhile, the Ministry of External Affairs noted "Uzbek authorities have not formally taken up the matter with India". It said the Indian embassy is in touch with Uzbekistan authorities. "Legal action has been initiated against Indian representatives of the company in Uzbekistan and we are providing consular assistance," the ministry added.
Besides this, the government also issued Ethylene Glycol (Quality Control) Order, 2022 which will come into force on March 28, 2023. It directs companies required to follow provisions under the Bureau of Indian Standards Act, 2016. The order applies to Ethyle Glycol and not to goods or articles meant for export.
What did WHO say?
The World Health Organization (WHO) responded to CNBC-TV18's query on the incident, saying that it is in contact with health authorities in Uzbekistan. It has added that its teams stand ready to assist Uzbekistan in further investigations.
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