The Indian authorities have started investigating the Uttar Pradesh-based pharmaceutical company after its cough syrup was connected by Uzbek authorities to deaths of 18 children.
The Uzbek Health Ministry has alleged that UP's Noida-based Marion Biotech's cough syrup Dok-1 is behind deaths of 18 children in Uzbekistan. The news comes just two months after cough syrup from another Indian company was linked to deaths of 66 children in Africa's Gambia.
Marion has stopped the manufacturing of the syrup in question for now as UP and Centre investigate it jointly.
Samples of the syrup have been taken and sent for testing in a government laboratory, according to Union Health Minister Mansukh Mandaviya.
What we know of cough syrup's link to deaths in Uzbekistan
Uzbekistan's authorities said 18 of the 21 children who took the cough syrup died.
Reuters reported the authorities as saying that they found ethylene glycol in the syrup. Ethylene glycol is a toxic substance and can cause death, according to US Centers for Disease Control and Prevention (US CDC).
"Ethylene glycol breaks down into toxic compounds in the body. Ethylene glycol and its toxic byproducts first affect the central nervous system (CNS), then the heart, and finally the kidneys. Ingesting enough can cause death. Ethylene glycol is odorless," says US CDC.
Reuters further reported, "It also said the syrup was given to children at home without a doctor’s prescription, either by their parents or on advice of pharmacists, with doses that exceeded the standard for children. It was not immediately clear whether all or any of the children had consumed the suspect batch or consumed more than the standard dose, or both, and when the syrup was given to them."
How has India responded to allegations?
The Union and UP governments have launched a joint investigation into the allegations, according to Mandaviya.
He added that samples have been taken and sent to Regional Drugs Testing Laboratory, Chandigarh for testing.
Mandaviya said on Twitter, "Regarding reports from Uzbekistan concerning contaminated cough syrup made by Indian company Marion Biotech, Noida, Uttar Pradesh, the Central Drugs Standard Control Organisation (CDSCO)is in regular contact with the national drug regulator of Uzbekistan since 27th December.
"Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by UP Drug Control and the CDSCO team. Further action as appropriate would be initiated based on the inspection report. The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory, Chandigarh for testing."
The Marion Biotech has said it has for now stopped manufacturing the cough syrup.
Marion Biotech does not sell Dok-1 Max in India and its only export has been to Uzbekistan, an Uttar Pradesh government official said.
Marion Biotech is a licensed manufacturer and holds the licence for manufacturing Dok-1 Max syrup and tablet 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, 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.
Sources said the Drugs Controller General of India (DCGI) has sought more information from the Uzbek regulator regarding the latest allegation.
Uzbekistan yet to raise issue formally: MEA
The Ministry of External Affairs (MEA) has said that the Uzbek authorities are yet to take up the case formally.
MEA spokesperson Arindam Bagchi also said consular assistance is being provided to some 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 ... We understand that legal action has been initiated by the Uzbek authorities against some people, including the local representative of the company there. And in that context, we are extending necessary consular assistance to those individuals or individual."
Company accused of deaths in Gambia complied with standards: India
India's drug regulator told the World Health Organization (WHO) earlier this month that the global health body drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe.
In a letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, DCGI Dr V G Somani said a statement issued by the global health body in October in the wake of the deaths "was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products".
In the letter, Somani said the samples of the cough syrups were tested in a government laboratory in the country and found to be complying with specifications.
The DCGI had said that India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics.
(With PTI inputs)