All manufacturing activities at Marion Biotech’s Noida unit have been stopped in view of reports of contamination of its cough syrup Dok-1 Max, Union Health Minister Mansukh Mandaviya said on Friday, 30 December.
Further investigation in connection with the death of 18 Uzbek children, allegedly after consuming the cough syrup is going on, he said in a tweet.
After the Central Drugs Standard Control Organisation (CDSCO) began a probe in connection with the death of 18 children in Uzbekistan, allegedly linked to pharma firm Marion Biotech’s Dok-1 Max, manufacturing of the cough syrup has been stopped “for now”, the company’s legal representative said on Thursday, 29 December.
Marion Biotech does not sell Dok-1 Max in India and its only export has been to Uzbekistan, an Uttar Pradesh government official said as inspection began at the company’s office in Noida on the outskirts of the national capital on Thursday morning.
According to Union Health Minister Mansukh Mandaviya, the CDSCO has been in regular contact with the national drug regulator of Uzbekistan regarding the matter since 27 December.
While Mandaviya said further action would be taken based on the inspection of the pharma company, which has been under a cloud since the Uzbekistan Health Ministry’s alleged that the children died after consuming Dok-1 Max.
Samples of the cough syrup have been taken from the manufacturing premises in Noida and sent to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh for testing, Mandaviya said, a day before stopping the production of the syrup.
Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing.
— Dr Mansukh Mandaviya (@mansukhmandviya) December 30, 2022
“Immediately on receipt of information, joint inspection of the Noida facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report,” Mandaviya said in a series of tweets.
India is in touch with the Uzbek authorities
The Ministry of External Affairs (MEA) said India is in touch with the Uzbek authorities and has sought details of their investigation into the matter. MEA spokesperson Arindam Bagchi also said consular assistance is being provided to some people linked to the company who are facing legal action there.
Noting that the Uzbek authorities have not formally taken up the matter with New Delhi, he said, “Nevertheless, our embassy has contacted the Uzbek side and is seeking further details of their investigation.”
Marion Biotech is a licensed manufacturer and holds the licence for manufacturing Dok-1 Max syrup and tablets for export purpose granted by the Drugs Controller, Uttar Pradesh, the Health Ministry said in a statement.
The governments of both countries are looking into the matter, said Hasan Harris, the legal representative of the Noida-based Marion Biotech.
“There is no problem from our end and no issue in testing. We have been there for the past 10 years. Once the government report will come, we will look into it. For now the manufacturing has stopped,” Harris told PTI.
Before Uzbekistan’s claims, there were reports linking the deaths of 70 children in Gambia to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals earlier this year. The Drugs Controller General of India claimed the WHO drew a premature link.
Sources said the DCGI has sought more information from the Uzbek regulator regarding the latest allegation.
According to the Uzbek ministry, the chemical ethylene glycol was found in a batch of Dok-1 Max syrup during laboratory tests.
Noida-based Marion Biotech is the flagship firm of the Emenox group which also has a presence in real estate and hospitals.
The privately held firm has a range of products spanning pharmaceuticals, nutraceuticals, herbals, and cosmetic products.
Founded in 1999, the company is understood to have a presence in Central Asian countries, Central and Latin America, South East Asia, and Africa. It claims to be the brand leader in the categories that it sells in these markets.
Marion Biotech is a licensed manufacturer and holds the license to produce Dok-1 Max syrup and tablets for exports granted by the Drugs Controller, Uttar Pradesh. It does not sell the Dok-1 Max syrup in India.
The company has a division, Emenox Healthcare which is into pharmaceutical manufacturing.
The Emenox group was founded by its Chairman Sachin Jain. It undertakes real estate development under its division Emenox Infratek, which was established in 2006.
(With PTI inputs)