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Health

Uzbekistan Child Deaths: Three of Noida-Based Firm Arrested for Contaminated Medicines

Noida drug inspector confirms to The Wire that a highly toxic industrial chemical, diethylene glycol (DEG), was found in the control samples of the batch of drugs that were exported to Uzbekistan.

Note: This article was originally published at 8:10 pm on March 2, 2023 and was republished at 3:20 pm on March 9, 2023 with the DGCI’s alert on raw materials.

New Delhi: Three people of Noida-based Marion Biotech were arrested on Friday, March 3, in a case regarding the exporting of contaminated paediatric medicines to Uzbekistan which allegedly resulted in the deaths of 18 kids in the country, in December 2022. 

Talking to The Wire, Noida drug inspector, Vaibhav Babbar, said on March 3, the three arrested people are the plant’s head, the manufacturing chemist, and the person who was responsible for testing and quality control. He added that the owners of the Noida-based firm, Sachin Jain and Jaya Jain, have also been named in the FIR lodged at a police station in Noida. “However, the owners are yet to be arrested, as they are not here [at Noida],” Babbar said. 

Babbar confirmed that the toxin diethylene glycol (DEG) has been confirmed in 22 samples collected from the plant where the said medicines – Ambronol cough syrup and Dox-1 Max syrup – were manufactured. He could not share in what proportion they were found in the samples collected. The World Health Organisation (WHO) had issued a product alert against these two medicines on January 11, linking them to the deaths.  

DEG is an industrial chemical which is highly toxic and is banned for usage in drugs. In drug manufacturing, propylene glycol (PG) is to be used as a solvent. But if enough attention is not paid to test raw materials for impurities, DEG can get mixed in finished products. Or, the manufacturer may also end up buying DEG-mixed PG in order to reduce the making expenditure.  

“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” the WHO had said in the alert.  

Besides the chemical impurities in the products of the Noida-based firm, which were exported to Uzbekistan, some of the samples also failed the assay test – the drugs were found to be containing their active ingredients not in the amounts that they were supposed to have – Babbar told The Wire.

In a similar case, DEG-contaminated paediatric drugs, made by another Indian firm, Maiden Pharmaceuticals, have allegedly been linked with 70 children in Gambia. However, Indian authorities had cleared the name of this firm in the incident saying their lab investigation did not reveal any sort of contamination in the control samples of the same batch exported to Gambia – even though WHO had found large amounts of DEG in the four products. 

Uzbekistan had first raised an alarm against these products on December 27, 2022. The WHO in its alert had also said that the Noida-based firm had failed to provide “guarantees to WHO on the safety and quality of these products”.  

Following the red flag from Uzbekistan, a team from the Central Drugs Standard Control Organisation (CDSCO) inspected the plant. Subsequently, the production was completely suspended in January as the manufacturer failed to provide the authorities with the documents that they sought during the inspection.

News18.com had reported that the drug inspectors had found shocking irregularities at the plant itself ranging from seeping walls, rusted equipment, unhygienic premises and missing batch numbers of the products, among others. What is, however, not known, is if this plant was surveyed earlier also by the drug authorities, as they are supposed to regularly do, for all drug manufacturing units. 

The Pharmaceuticals Export Promotion Council of India, a body that functions under the Union commerce ministry, suspended the licence of Marion Biotech after the Uzbekistan incident, in December. 

According to media reports published on March 9, the drug controller has now instructed state drug control authorities to ask drug manufacturers under their respective jurisdictions not to use propylene glycol supplied by a firm, Maya Chemtech – which had supplied the raw material to Marion Biotech. The drug controller has also asked the state authorities to maintain a strict vigil on this matter.