The Uttar Pradesh state drug controller has ordered Marion Biotech to completely halt the production all drugs in its Noida unit. According to the officials involved in the inspection of plants at Noida, a deviation from Schedule M for Good Manufacturing Practices was observed at Marion's plant and the regulators have asked the company to stop the total production at this unit.
The inspection got completed at the midnight and after inspecting the plant the decision has been taken to completely halt the drug production, an official told Moneycontrol.
Also read: Exclusive | Uzbek Cough Syrup row: Drug regulators inspect Marion Biotech's manufacturing site
A Central Drug Regulator official told that the company may be served a show cause notice as per the observations of inspection report.
"They will have to clarify their position on flouting the norms of GMP practices," he added.
When asked if the company's license would be suspended, the official said, the investigation in this matter is ongoing.
The decision to ban the production at Marion Biotech's plant was taken after two separate inspections were conducted by joint team of Central Drug regulator and Uttar Pradesh Drugs Controlling and Licensing Authority, top government sources told Moneycontrol.
Health Minister Mansukh Mandaviya announced the ban and posted the official announcement on Twitter. ''Following inspection by CDSCO
team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing,'' he tweeted.
"We regret deaths, govt is conducting enquiry. We'll take action as per report. Samples were collected. Manufacturing of that product has been halted as of now & other processes are underway," stated Hasan Raza, Marion Biotech Pharma Company legal head on syrup deaths in Uzbekistan
The samples of Doc 1-Max cough syrup have been sent for testing to regional testing lab in Chandigarh for contamination as it was done in the case of Gambia.
Uzbekistan’s Health Ministry has claimed that at least 18 children with acute respiratory disease died after drinking a cough syrup manufactured by Noida-based Marion Biotech.
“To date, 18 out of 21 children with acute respiratory disease have died as a result of taking the Doc-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 Health Ministry of Uzbekistan said in a release.
The Ministry of Health of Uzbekistan said that preliminary laboratory studies have shown that this series of Doc-1 Max syrup contained ethylene glycol.
Union health minister Mansukh Mandaviya yesterday said Indian drug regulator had been in regular contact with the drug regulators of Uzbekistan.
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