Marion Biotech, the Noida-based firm which is being linked to the deaths of 18 children in Uzbekistan allegedly due to contaminated cough syrups, has been asked to completely halt production activities at its plant. The decision was taken by the Uttar Pradesh state drug controller after it wrapped up an inspection at the company's Noida plant at midnight.
According to reports, a deviation from schedule M of Good Manufacturing Practice (GMP), a system for ensuring that products are consistently produced and controlled according to quality standards, was observed at Marion's plant. The Central Drug Controller may serve the company a show cause notice as per the observations of the inspection report, NDTV reported.
“All manufacturing activities of Marion Biotech, in Noida, stopped in view of reports of contamination in cough syrup Dok1 Max,” Union Health minister Mansukh Mandaviya tweeted.
Uzbekistan’s Health Ministry has claimed that at least 18 children with acute respiratory disease died after drinking a cough syrup manufactured by Marion Biotech. According to the ministry, chemical ethylene glycol was found in a batch of syrup during laboratory tests. India has sought more details from the Uzbek drug regulator, and a probe was jointly launched by the central drugs regulatory team of north zone and the UP state drugs regulatory team.
The samples of the cough syrup have been taken from the manufacturing premises and sent to the Regional Drugs Testing Laboratory, Chandigarh for testing.
"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," Uzbekistan’s Health Ministry said in a press release. As of now, Doc-1 Max tablets and syrups have been withdrawn from all pharmacies in the country.
In a similar case earlier this year, Haryana-based Maiden Pharmaceuticals was red-flagged by the World Health Organisation after it was allegedly linked to the death of over 80 children in the west African country of Gambia. However, earlier this month, the samples tested in a government lab in India were found to be complying with quality specifications. India's drug regulator told the WHO that the global health body drew a premature link between the deaths of children in Gambia and the four India-made cough syrups, which adversely impacted the image of the country's pharmaceutical products across the globe.
-with agency inputs
