Late Thursday night, Marion Biotech’s manufacturing plant in Noida was shut down due to “deviations” from good manufacturing procedures discovered during a joint inspection by the supreme drug regulator and state drug controllers. The examination occurred when the government of Uzbekistan linked the deaths of 18 infants to a cough medication manufactured by the firm.
“Following an inspection by the CDSCO (Central Drugs Standard Control Organisation) team in response to reports of contamination in cough syrup Dok1 Max, all manufacturing activities at Marion Biotech’s Noida unit were halted last night,” tweeted Union Health Minister Mansukh Mandaviya on Friday. “An investigation is ongoing,” he added.
The order to cease all production “in the public interest” was issued on the spot by drug controllers on the second day of continuing inspections, according to officials. According to the officials, drug controllers took 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, shortly after Uzbekistan’s health ministry linked the deaths of the children to the Dok1 Max syrup.
The samples have been forwarded for testing to the Regional Drugs Testing Laboratory in Chandigarh.
Thursday’s examination discovered violations of the 1940 Drugs and Cosmetics Act’s Schedule M good manufacturing practices. “There are precise requirements for conducting testing that were not met. There are locations where pressure differences should have been maintained, but they were not. A few of the magnehelic gauges (used to record pressure variations) were malfunctioning. All deviations were compiled and provided to the corporation, according to a senior person with knowledge of the situation.
On Friday, a show-cause notice was issued to the corporation.
On Thursday, the Union Health Minister had stated, “Further action, as needed, will be taken based on the inspection findings.”
Officials stated there is currently no need for a further inspection of the plant.
According to a statement by the Uzbek ministry of health, at least 18 youngsters who had taken Dok-1 Max syrup in the city of Samarkand died of kidney failure. Initial laboratory testing on the syrup confirmed the presence of the pollutant ethylene glycol, and the affected youngsters ingested the syrup without a prescription and in higher dosages than recommended for their age.
The World Health Organization informed The Indian Express on Wednesday that it is in contact with Uzbek health authorities and is prepared to assist with further investigations.
Thursday, Arindam Bagchi, a spokesperson for the Ministry of External Affairs, stated, “The Uzbek authorities have not formally raised the issue with us. However, our embassy has contacted the Uzbek side and requested additional information about their probe.”
The Indian Express reported last week that a committee of the Gambian National Assembly had found that four tainted syrups manufactured by the Indian pharmaceutical company Maiden Pharmaceuticals were responsible for the deaths of 70 children owing to acute kidney damage. In its findings, the committee suggested that Maiden be placed on a blacklist, that its products be prohibited from the Gambian market, and that legal action be taken against the company.
The event in Gambia prompted the CDSCO to initiate a nationwide inspection of manufacturing facilities deemed at risk of producing contaminated, counterfeit, or substandard products earlier this month.
“It is regrettable that this occurred, but it has helped us identify the holes. “Fortunately, oversight is being expanded as the pharmaceutical business in the United States expands,” a government official stated.