The manufacturing licence of Noida-based pharmaceutical firm Marion Biotech was cancelled on Wednesday by Uttar Pradesh authorities, according to officials.
Marion Biotechs cough syrup Dok-1 was linked with the death of 18 children in Uzbekistan. The incident which happened last December had prompted central and state drug authorities in India to launch a probe into the matter.
“The firm’s licence was under suspension since January after which a detailed inquiry was initiated. Now the licence of the firm has been cancelled by the Uttar Pradesh Drugs Controlling and Licensing Authority. The firm can no longer manufacture the syrup,” a government official said.
On March 3, the Noida Police had arrested three employees of Marion Biotech from its office in Sector 67 while a lookout notice was issued for two of its directors after an FIR was lodged against all of them, the official said.
The FIR had come in the wake of investigations finding that samples of Marion Biotechs drugs were “adulterated” and “not of standard quality.”
The samples were sent to the government’s regional drug testing laboratory in Chandigarh and 22 of them were found to be not of standard quality (adulterated and spurious), according to the FIR.
The FIR has been lodged under Indian Penal Code sections 274 (adulteration of drugs), 275 (sale of adulterated drugs), 276 (sale of drug as a different drug or medical preparation) as well as under Section 17 (misbranded drugs) and related violations of the Drugs and Cosmetics Act, 1940. Marion Biotech had come under the scanner in December last year for its cough syrup Dok-1 that is suspected to have led to the death of 18 children who consumed it in Uzbekistan after which the CDSCO launched a probe into the matter.
The production licence of the firm was suspended in January after inspections at its site by the central and the state drug authorities in the wake of the controversy. On January 12, the World Health Organization (WHO) had also issued a medical product alert, referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022.
“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 had stated then.
“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 had noted.
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