“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,” Union Health Minister Mansukh Mandaviya said on Friday in a Twitter post.
The order to stop all manufacturing, “in public interest”, was handed to the firm on the spot by drug controllers after the second day of the ongoing inspections, officials said. According to the officials, drug controllers had taken control samples (samples of the same batch that was exported, stored by the company for quality control purposes), along with samples of other medicines manufactured at the Noida facility, on Tuesday soon after Uzbekistan’s ministry of health linked the deaths of the children to the Dok1 Max syrup.
The samples have been sent to Regional Drugs Testing Laboratory, Chandigarh for testing.
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Thursday’s inspection revealed lapses in good manufacturing practices as listed in Schedule M of the Drugs and Cosmetics Act, 1940. “There are certain specifications for conducting tests that were not followed. There are areas where pressure differences needed to be maintained, but weren’t. Some of the magnehelic gauges (used to record pressure differences) were not working. All the deviations were tabulated and given to the company,” a senior official with knowledge of the matter said.
A showcause notice has been issued to the company on Friday.
“Further action as appropriate will be initiated based on the inspection report,” the Union Health Minister had said on Thursday.
Officials said there was no need for further inspection of the facility as of now.
According to a statement by Uzbekistan’s ministry of health, at least 18 children who had consumed the Dok-1 Max syrup reported sick to hospitals in the Uzbek city of Samarkand and died of kidney failure. The statement said that preliminary laboratory tests of the syrup revealed the presence of the contaminant ethylene glycol, and that the affected children had consumed the syrup without a prescription and in higher doses than recommended for their age.
The World Health Organisation had on Wednesday told The Indian Express that the “WHO is in contact with health authorities in Uzbekistan and is ready to assist in further investigations”.
Arindam Bagchi, spokesperson of the Ministry of External Affairs spokesperson, on Thursday said, “The Uzbek authorities have not formally taken up the matter with us. But our embassy has contacted the Uzbek side and is seeking further details of their own investigation.”
Last week, The Indian Express reported that a select committee of the Gambian National Assembly had concluded that the deaths of 70 children due to acute kidney injury were linked to their consumption of four contaminated syrups made by Indian pharma firm Maiden Pharmaceuticals. The committee, in its report, recommended that Maiden be blacklisted, its products banned in the Gambian market and legal action be pursued against the company.
The Gambia incident had prompted the CDSCO earlier this month to starting a nation-wide inspection of manufacturing units considered to be at risk of manufacturing products that are adulterated, spurious, or not upto standard.
“It is unfortunate this happened, but it has helped us realise the gaps. Fortunately, oversight is being increased at a time when the pharma industry in the country is growing,” an official said.
This content was originally published here.
