A joint team of central and state drug regulators was inspecting Marion Biotech's unit in Uttar Pradesh’s Noida on January 12, a day after the World Health Organisation (WHO) flagged two of its cough syrups as contaminated, sources said.
The WHO's move, the second such alert against an Indian pharma company in the last three months, comes after one of the cough syrups made by the Noida-based pharma firm was linked to the death of 18 children in Uzbekistan.
Officials from the Central Drug Standard and Control Organisation (CDSCO) and the Uttar Pradesh Food Safety and Drug Administration Department (UPFSD) were visiting the plant after WHO issued a "medical product alert" for two substandard (contaminated) products, the sources said.
“The two products mentioned by WHO are Ambronol syrup and Dok-1Max syrup. The samples of Dok-1Max cough syrup are already in the lab for testing. The samples of Ambronol syrup will be collected today,” an official told Moneycontrol on the condition of anonymity.
Also read: UP suspends manufacturing license of drug maker Marion Biotech
The official said neither Ambronol nor Dok-1Max syrup, which was linked to the deaths in Uzbekistan, was sold in India.
In a release issued on December 27, Uzbekistan’s health ministry claimed that 18 out of 21 children with acute respiratory disease died after taking Dok-1 Max syrup.
"It was found that the deceased children, before admission to hospital treatment, took this drug at home for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children,” the ministry said. Laboratory studies showed that Doc-1 Max syrup supplied in the country contained ethylene glycol, the release added.
Also read: Drug contamination reports hurt Indian pharma, government must find a way
On the delay in the results of the samples sent to the Central Drug Testing Lab in Chandigarh, the official said it would take some time as more than 30 to 32 samples of Dok-1Max syrup were collected.
“The Ambronol syrup samples will also be sent for testing for di- ethylene glycol and ethylene glycol,” he added.
The Drug Controller General of India didn't respond to Moneycontrol's queries on Marion Biotech's product being flagged by the WHO.
The UP FSDA suspended the production licence of Marion Biotech January 9. “We have suspended the drug manufacturing licence of Marion Biotech. The company hasn’t responded to the show-cause notice issued by us on the reason for manufacturing violations at the production plant in Noida,” an official at the department told Moneycontrol.
Also read: Pharmexcil suspends membership of Marion Biotech
According to the official, Marion Biotech founders had two licences to manufacture different types of drugs at Noida, its only manufacturing facility.
The WHO had in late 2022 issued an alert for four “contaminated medicines” identified in The Gambia that were potentially linked to acute kidney injuries and 66 deaths among children. The world health body recommended that all countries remove the four cough syrups from circulation to prevent further harm.
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