INDIA – Marion Biotech has lost its licenses to both manufacture and sell its cough syrup, Dok-1 MAX, which is suspected to have led to the death of 18 children who consumed it in Uzbekistan.
The news comes after authorities ordered Marion Biotech to halt production at its main plant in Noida in India’s northern state of Uttar Pradesh.
The contaminated products, Ambronol syrup, and DOK-1 Max syrup were identified in Uzbekistan and reported to the WHO on Dec. 22 of last year.
WHO said the products, manufactured by India’s Marion Biotech, were “substandard” and that the firm had failed to provide guarantees about their “safety and quality.”
What’s more, all participants in the drug supply chain called on stakeholders to take immediate coordination measures and Uzbekistan banned the import and sale of DOK-1 Max.
Marion Biotech’s licence was under suspension since January 2023 and a detailed inquiry was initiated under three articles of the Criminal Code.
Uttar Pradesh Drug Controller Authority cancelled the manufacturing licence of the firm after investigations found that samples of its drugs were “adulterated” and “not of standard quality”.
The investigations revealed that highly toxic substances, Ethylene glycol (EG) and diethylene glycol (DEG,) were found in the preparations DOK-1 MAX and Ambronol produced by Marion Biotech.
Diethylene glycol and ethylene glycol are toxic to humans and, if consumed, can be fatal.
The drug samples were sent to the government’s regional drug testing laboratory in Chandigarh and 22 of them were found to be “adulterated and spurious”, according to the First Information Report (FIR).
The FIR has been lodged under Indian Penal Code sections 274 (adulteration of drugs), 275 (sale of adulterated drugs), 276 (sale of a drug as a different drug or medical preparation) as well as under Section 17 (misbranded drugs) and related violations of the Drugs and Cosmetics Act, 1940.
The regulatory decision comes shortly after the Indian government pushed back allegations that cough syrups made by another Indian company, Maiden Pharmaceuticals, led to tragic fatalities.
The WHO linked New Delhi-based Maiden Pharmaceuticals cough syrups to a spate of child deaths in Gambia.
The Gambia’s medical authorities discovered an increase in cases of acute kidney injury among children under the age of five in late July. The government later stated that 69 children had died as a result of these injuries.
The alerts over Indian medicines are a blow to the reputation of one of the country’s top industries. India produces one-third of the world’s medicines, the majority of which are generic drugs.
The country is known as the “world’s pharmacy” and meets a large portion of the medical needs of African nations. It is home to some of the fastest-growing pharmaceutical companies.
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