According to officials, the Uttar Pradesh authorities have revoked the manufacturing licence of Marion Biotech, a pharmaceutical company situated in Noida.
The cough medication Dok-1 manufactured by Marion Biotech has been linked to the deaths of 18 children in Uzbekistan. The occurrence in India last December prompted the country’s government and state narcotics authorities to investigate the situation.
“The company’s licence was suspended in January, after which a thorough investigation was launched. The Uttar Pradesh Drugs Controlling and Licensing Authority has now revoked the organization’s licence. “The company can no longer produce the syrup,” a government representative said on Wednesday.
The officer stated that on March 3, the Noida Police arrested three employees of Marion Biotech from its office in Sector 67 and issued a lookout notice for two of its directors after filing an FIR against them all.
The FIR was filed after investigations revealed that Marion Biotech’s medicine samples were “adulterated” and “not of standard grade.” According to the FIR, 22 of the samples sent to the government’s regional drug testing laboratory in Chandigarh were determined to be “not of standard grade” (adulterated and counterfeit).
The FIR was filed under Indian Criminal Code sections 274 (adulteration of drugs), 275 (selling of adulterated drugs), and 276 (sale of the drug as distinct drug or medical preparation), as well as Section 17 (misbranded drugs) and associated offences of the Drugs and Cosmetics Act, 1940.
In December of last year, Marion Biotech came under scrutiny for its cough medication Dok-1, which is believed to have caused the deaths of 18 children in Uzbekistan. As a result, the CDSCO initiated an investigation into the case.
In January, the company’s production licence was stopped following inspections at its location by central and state narcotics authorities in response to the scandal.
The World Health Organization (WHO) issued a “medical product alert” on January 12 about two substandard (contaminated) items discovered in Uzbekistan and reported to it on December 22, 2022.
Ambronol syrup and DOK-1 Max syrup are the two items in question. MARION BIOTECH PVT LTD is listed as the manufacturer of both goods (Uttar Pradesh, India). The manufacturer has not yet supplied WHO with assurances regarding the safety and quality of these items, the WHO stated at the time.
“Laboratory analysis of samples of both goods, conducted by the national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan, revealed that both products contained prohibited levels of diethylene glycol and/or ethylene glycol as contaminants,” the report stated.
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