Uzbek deaths: Centre's drug regulatory team inspects Noida firm, takes samples
Aditi Tandon
New Delhi, December 29
India on Thursday began probing Uzbekistan health ministry’s statement linking the death of 18 children in the country to cough syrup and tablets exported by Noida-based Marion Biotech, with officials of the apex drug regulatory body and Uttar Pradesh Government inspecting the company’s premises.
Further action after probe report
Immediately on receipt of information, joint inspection of Marion Biotech was carried out by UP drug control and CDSCO team. Further action as appropriate would be initiated based on the inspection report. Mansukh Mandaviya, Health Minister
Sought probe details: MEA
- India is in touch with the Uzbek authorities and has sought details of their probe into the death of 18 kids, the MEA has said
- Indian embassy in Tashkent extended its condolences to family members of the victims
- MEA spokesperson Arindam Bagchi said consular assistance is being provided to some linked to the firm, including an Indian who has been reportedly arrested in Uzbekistan
- Bagchi said Uzbek authorities have not formally taken up the matter with India but “our embassy has contacted the Uzbek side and is seeking further details of their probe”
Not sold in india
Like Sonepat-based Maiden Pharma, which was ‘linked’ by WHO to Gambian deaths, Noida-based Marion Biotech too had a manufacturing licence to export Dok-1 Max. It does not sell Dok-1 Max in India and exports the drug to just Uzbekistan. — UP official
Samples with Chd lab
Uzbekistan Govt has claimed the presence of ethylene glycol in Marion Biotech export consignment, a claim India has begun probing by sampling the product from Noida and sending it to Regional Drugs Testing Laboratory (RDTL) in Chandigarh.
Drug inspectors have taken specimens of control samples (the same batch as exported) of the drug in question, Dok-1 Max, and sent it for testing to the Regional Drugs Testing Laboratory (RDTL) in Chandigarh.
The firm, meanwhile, has halted the production of the drug. Health Minister Mansukh Mandaviya said India’s apex drug regulator, Central Drugs Standard Control Organisation (CDSCO), had been in touch with the Uzbek counterpart over the matter since December 27.
“Immediately on receipt of the information, a joint inspection of Marion Biotech’s Noida facility was carried out by the UP Drug Control team and the CDSCO. Further action as appropriate would be initiated based on the inspection report. The samples of the cough syrup have been taken from the manufacturing premises and sent to the RDTL, Chandigarh, for testing,” Mandaviya said.
Marion Biotech has a licence granted by UP Drugs Controller to manufacture Dok-1 Max. The product is not meant for sale in India, much as the case was with the Sonepat-based Maiden Pharma which had a manufacturing licence to export four cold and cough syrups. The firm was mentioned in WHO’s October 5 global alert over the death of nearly 70 Gambian children.
Gambia had alleged the presence of contaminants diethylene glycol and ethylene glycol (EG) in the Maiden Pharma export consignment. The CDSCO has, however, contested the WHO alert and sought evidence of a causal relationship between the Indian drug and Gambian child deaths, saying lab reports at home revealed no contamination. Uzbekistan has now again claimed the presence of ethylene glycol in Marion Biotech export consignment, a claim India has begun probing by sampling the product from Noida today and sending it for tests. Hasan Harris, legal representative of Marion Biotech, today said the firm had no issues with testing and had been around for 10 years. “Once the government report comes, we will see. For now the production of the drug has been stopped,” he said.
With the matter under investigation, the Congress and the BJP clashed on the issue today after AICC general secretary Jairam Ramesh said, “Made-in-India cough syrups seem to be deadly. First it was the deaths of 70 kids in Gambia and now it is that of 18 children in Uzbekistan. Modi sarkar must stop boasting about India being a pharmacy to the world and take strictest action.”
BJP spokesperson Sudhanshu Trivedi hit back terming Ramesh’s comments “most unfortunate”. “The truth is that the children unfortunately died because of taking non-prescribed medicines. The Congress remarks are an attack on the Indian pharma industry, which stood its ground during Covid and when Chinese drug exports fell 64%…,” Trivedi said.
BJP’s IT cell chief Amit Malviya said the death of Gambian children “had nothing to do with the consumption of cough syrup made in India”. “The matter has been clarified by the Gambian authorities and the DCGI, both,” Malviya said.
Importantly, India ordered joint inspection of “identified drug factories” by Central and state authorities two days ago, the same day as Uzbekistan health ministry linked the deaths of 18 children to the Marion Biotech-made drug.
Uzbekistan said parents of deceased kids had administered high doses of the syrups mistaking the anti-cold medicine for paracetamol.
