The Department of Food Safety and Drug Administration of Uttar Pradesh, India, has suspended Marion Biotech Pvt., the manufacturer of Dok-1 Max. Ltd.’ production license. This was reported by Moneycontrol.
The suspension of the license is directly related to the death of 20 children in Uzbekistan after taking the drug "Dok-1 Max".
“We have suspended the drug manufacturing license 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.
The founders of Marion Biotech had two licenses: Form 25 and Form 28, to manufacture different types of drugs at their Noida plant.
"The company had two types of licenses to manufacture biologics and non-biologics, and both have been suspended until further notice," it said.
On December 30th, the directors of Marion Biotech were sent a formal notice and were ordered to respond by January 5th. The regulator delayed the license suspension after the company failed to respond by January 5. This is because the company is waiting for the results of the cough syrup tests.
"We gave more time, but the company did not respond and after assessing the irregularities found in the factory during the inspection, a decision was taken to suspend the manufacturing license," said the Uttar Pradesh Food Safety and Drug Administration. department of means management.
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