The batches of cough syrup linked to the deaths of 18 kids in Uzbekistan had been exported by Noida-based Marion Biotech to the central Asian country in May 2021, and the company at present was not producing the drug.
Top sources in the central and state drug regulatory authorities who are carrying out a joint probe at the drug manufacturer’s plant said that the government may pass an order to stop category-wise production of the medicines, based on the findings.
“We are testing the quality of the excipients and active ingredients used in all the drugs manufactured in the plant, as well as probing whether the proper process of documentation, as prescribed in the Good Manufacturing Practices certification, has been followed,” said a senior official.
“In the next few hours, we may decide on whether the production of specific categories of drugs — such as liquid-based medicines and tablets — should be totally suspended,” the official also said, adding on December 28 and 29 production of drugs at the plant remained mostly suspended.
When Moneycontrol visited the company on December 29, the joint inspection by the drug regulatory authority was still underway, while its campus remained tightly shut for visitors. Not even the police, when they arrived, were allowed to enter the company premises.
Uzbekistan’s health ministry, on December 28, had said in a statement that DOK-1 Max, a cough syrup supplied by Marion Biotech, was found contaminated with ethylene glycol, a toxic substance, in the initial laboratory investigations and said it had killed 18 kids.
India’s health ministry, meanwhile, confirmed that joint inspection of the drug manufacturing unit was carried out by Uttar Pradesh Drug Administration and Central Drugs Standard Control Organisation (CDSCO) team and the samples of the cough syrup have been taken from the manufacturer’s premises and sent to Regional Drugs Testing Laboratory, Chandigarh, for testing.
“Marion Biotech is a licensed manufacturer and holds license for manufacturing of DOK-1 Max syrup and tablet for export purpose granted by Drugs Controller, Uttar Pradesh,” it said.
‘No problem from our side’
Meanwhile, Hasan Harris, legal head of Emenox Group, the parent company of Marion Biotech, said that the firm regrets the incident and action would follow the government enquiry report, but maintained that “there is no problem on the company’s part”.
Also read | Exclusive | Uzbekistan Cough Syrup Case: Drugs sold by Marion Biotech in India under scanner
“We regret the deaths; the government is conducting an enquiry. We’ll take action as per the report; there is no problem on our part,” Harris told mediapersons on December 29.
Meanwhile, government officials said that Marion Biotech’s unit in Noida has the World Health Organisation (WHO) GMP certification and several of its product, including DOK-1 Max syrup and tablets, have the Certificate of Pharmaceutical Product (CoPP) granted by the drug regulators in India.
Experts say that CoPP is often seen as a guarantee by importing countries that the imported drug is of the relevant standard in terms of quality, safety and efficacy, and has undergone rigorous testing and inspection in the exporting country.
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