18 Uzbekistan kids dead: Samples from Noida pharma firm sent to lab for tests

The government said a joint inspection was conducted by the country’s apex drug regulator and the UP drug controller at the manufacturing facility of the company in Noida on Tuesday and Thursday. Samples of the cough syrup have been taken from the manufacturing premises and sent to the Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing. It said “further action as appropriate would be initiated based on the inspection report”.

Union Health Minister Mansukh Mandaviya said Thursday that the Central Drugs Standard Control Organisation was in touch with the drug regulator in Uzbekistan.

A statement from the Health Ministry said, “There have been reports from Uzbekistan concerning contaminated cough syrup Dok1 Max made by Indian company Marion Biotech, Noida, Uttar Pradesh. Under direction of the Union Minister of Health & Family Welfare and Chemicals & Fertilizers, Dr Mansukh Mandaviya, the Central Drugs Standard Control Organisation (CDSCO) has been in regular contact with the national drug regulator of Uzbekistan regarding the matter since 27th December, 2022.”

“Immediately on receipt of the information, joint inspection of the Noida facility of the manufacturer, Marion Biotech, was carried out by the UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report,” it stated.

“Marion Biotech is a licensed manufacturer and holds a licence for manufacturing of Dok1 Max syrup and tablet for export purposes granted by the Drugs Controller, Uttar Pradesh. The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing,” the Health Ministry said.

Responding to questions from reporters, Arindam Bagchi, spokesperson for the Ministry of External Affairs, 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.”

“We understand that legal action has been initiated by the Uzbek authorities against some people including the local representative of the company there. And in that context, of course, we are extending necessary consular assistance to those individuals or individual,” he said.

In Noida Thursday, the gates of the Emenox Group, of which Marion Biotech is a part, remained closed while the inspection was underway.

Hasan Harris, from the legal team of the company, said, “We regret the deaths… but why the deaths happened is being investigated by the government. There was no problem from our end, what happened there we cannot say. All the processes are underway.” He said the company has been exporting the medicine for almost 10 years.

Uzbekistan said Wednesday that at least 18 children died in Samarkand after allegedly consuming Dok-1 Max.

According to a statement by the Uzbekistan Health Ministry, laboratory tests of the preparation found presence of the contaminant ethylene glycol. It said the medicine was consumed without prescription and in a higher dose by the children affected.

The statement said the substance is toxic and consuming 1-2ml/kg of 95% concentrated solution can cause vomiting, fainting, convulsions, cardiovascular problems and acute kidney failure.

Ethylene glycol was also one of the contaminants found in four India-manufactured syrups that were linked to the deaths of 70 children in The Gambia earlier this year.

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.

Between June and November this year, 82 children were confirmed to have suffered acute kidney injury in The Gambia. Of them, 70 died.

Maiden denied the allegations. Its manufacturing unit in Sonepat was shut down by the CDSCO for alleged irregularities in processes.