Noida/Geneva, The production licence of Noida-based pharmaceutical firm Marion Biotech, allegedly linked with the deaths of children in Uzbekistan, has been suspended while the test results of its controversial cough syrup are awaited, an Uttar Pradesh drug official said Thursday. A team of central agencies and the Uttar Pradesh drug department on Thursday carried out a fresh inspection at Marion Biotech’s office here, a day after the World Health Organisation (WHO) issued a medical product alert on Ambronol and Dok-1 Max syrups, both manufactured by the firm.
India’s central regulatory body for pharmaceuticals and medical devices, the Central Drugs Standard Control Organisation (CDSCO), had in December initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to Marion Biotech’s cough syrup.
The health ministry of Uzbekistan claimed these children had consumed the cough syrup.
The central and state teams had earlier carried out an inspection at the firm’s office on December 29 and taken six samples of Dok-1 Max for testing, while on Thursday they took four samples of Ambranol, the official said.
During the December 29 inspection, the firm representatives could not produce documents related to the production of ‘Dok-1 max’ cough syrup, prompting the government to order halting of its production immediately, Gautam Buddh Nagar Drug Inspector Vaibhav Babbar said.
“The production licence of the firm remains suspended, as was ordered on December 29. Now the suspension order has been issued in writing to the firm on January 10 and has been acknowledged by the firm,” Babbar told PTI.
“On Thursday a fresh inspection was done during which four samples of Ambranol cough syrup taken for testing. Documents related to Ambranol production were also examined,” he said.
On the status of the test results, the officer said the samples were taken by the central agencies and their results are yet to arrive.
Marion Biotech did not sell ‘Dok-1 Max’ and Ambronol in India and its only export has been to Uzbekistan, Babbar said and estimated that the company exported around 1 lakh Dok-1 Max syrups in 45 days.
On Wednesday, the WHO also issued a ‘medical product alert’, referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.
According to WHO, substandard medical products are those that fail to meet quality standards or specifications and are therefore “out of specification.”
“The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the WHO stated.
“Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants,” it said.
The global health body said that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” it said.
The WHO also noted that both of these products “may have marketing authorizations” in other countries in the region. “They may also have been distributed, through informal markets, to other countries or regions.”
Hasan Harris, a legal representative of Marion Biotech, had earlier said that the governments of both countries are looking into the matter.
The company had stopped production of the cough syrup after the case came to light.