- Friday, April 19, 2024
By: Shubham Ghosh
The Food Safety and Drug Administration Department of the northern Indian state of Uttar Pradesh has suspended the production license of Marion Biotech Pvt Ltd, a drug manufacturer based in Noida in the state that produced a cough medicine which was linked to deaths of 18 children in the central Asian country of Uzbekistan.
Moneycontrol, which reported about the development quoted an official of the department as saying that while the drug-manufacturing license of Marion Biotech was suspended, the latter was yet to respond to the show-cause notice that was served by the authorities “on the reason for manufacturing violations” at the production plant in Noida.
The official also said that Marion Biotech’s founders had two licenses — Form 25 and Form 28 — for manufacturing different types of drugs at the Noida factory, the report added.
“The company possessed two types of licenses for production of biological and other-than-biological drugs and both have been suspended until further notice,” he added.
All production was stopped at the manufacturing facility of pharmaceutical company Marion Biotech late on December 29 following a joint inspection by the apex drug regulator and state drug controllers which reportedly found “deviations” from good manufacturing practices.
The drive came after the government of Uzbekistan linked the children’s deaths in the country.
“Following inspection by the CDSCO (Central Drugs Standard Control Organisation) 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,” Indian health minister Mansukh Mandaviya said in a Twitter post on December 30.
The order to stop all manufacturing, “in public interest”, was given to the firm on the spot by drug controllers after the second day of the inspections, officials said.
According to them, the drug controllers had taken control samples (samples of the same batch that was exported and stored by the company for quality-control), along with samples of other medicines manufactured at the facility in Noida, on December 27, soon after Uzbekistan’s health ministry linked the deaths of the children to the Dok1 Max syrup.
