The Uttar Pradesh Drugs Controlling and Licensing Authority on March 4 said estranged pharma firm Marion Biotech, which had supplied the cough syrups that reportedly caused the deaths of children in Uzbekistan, will be asked to recall its products from abroad and an alert for the same may be issued soon.
Vaibhav Babbar, drug inspector, Noida told Moneycontrol that the state drug regulator will also be issuing orders for cancellation of the manufacturing license of Marion Biotech.
“Total 22 out of 36 samples of drugs from Marion Biotech have been found adulterated with Ethylene Glycol and Di-ethylene Glycol, contaminants linked to deaths of children in Uzbekistan,” he added.
News agency ANI also reported that the Union government has recommended the state drug authority to cancel Marion Biotech's manufacturing licence.
Uzbekistan cough syrup matter | Centre recommends the State Drug Controller Authority to cancel manufacturing licence of Marion biotech after 22 out of 36 samples taken for testing from it were found adulterated with Ethylene glycol: Gautam Budh Nagar Drug inspector, UP pic.twitter.com/A0noSUnwRF— ANI (@ANI) March 4, 2023
The development comes after 22 out of 36 samples collected by the joint team of Central Drugs Standard Control Organization and Uttar Pradesh’s drug regulator were declared on March 3 as ‘Not of Standard Quality’ (Adulterated and Spurious).
ALSO READ: Killer Cough Syrup: Marion Biotech used untested ingredients procured from unapproved vendors
The state Drugs Controlling and Licensing Authority had already suspended the manufacturing license of the company after the World Health Organisation issued a medical alert on two drugs manufactured by them.
“Since it has been found that the company’s drug manufacturing practices were compromised, they will have to recall the product from the market. They don’t supply drugs in the Indian market, they will have to recall the product from the countries they have supplied,” Babbar told Moneycontrol.
“The company will be ordered to recall the product, but they may also challenge it, since adulteration has been confirmed, it’s unlikely that they will get any breather,” Babbar, meanwhile, said.
The analysis was done by government analysts in the Regional Drugs Testing Laboratory, Chandigarh.
Ashish Kondal, Drug Inspector, CDSCO, North Zone, Ghaziabad had filed a complaint for registering an First Information Report (FIR) against five officials of Marion Biotech for manufacturing and selling adulterated and spurious drugs.
Three officials from Marion Biotech have been arrested by Noida Police for selling adulterated medicine.
Kondal accused the Noida based company for allegedly disposing-off the materials and records related to drugs manufacturing.
The Noida police arrested Tuhin Bhattacharya, Head Operation; Atul Rawat, Manufacturing Chemist; and Mool Singh, Analytical Chemist under different sections of Indian Penal Code.
Meanwhile, company founders Sachin Jain and Jaya Jain are still at large and haven’t been arrested yet.
Marion Biotech, which has been a registered business entity in Uzbekistan since 2012, exported AMBRONOL syrup and Dok-1 Max cough syrup to Uzbekistan.
The government officials have said that the cough syrups haven’t been sold and consumed in India.
After the report of the death of 18 children in Uzbekistan, the CDSCO ordered an inspection and testing of the drug manufacturing facility.
The Health Ministry of Uzbekistan its complaint had said that “Both the syrups contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants.”
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