India investigates drugs linked to the deaths of more than 60 children

New Delhi, Oct 6 (EFE).- The Indian government said Thursday that regulatory bodies were investigation into several medicines for children produced in the Asian country, after the World Health Organization (WHO) associated it with the death of more than 60 children in the Gambia.

The drug regulatory body of India, CDSCO, has launched a “detailed investigation” to “ascertain the facts/ details in the matter” the Health Ministry said in a statement.

On Sep.29, WHO informed the Indian authorities of suspected contaminants in four medicines manufactured in India that could be a contributing factor in the deaths, and the matter was addressed immediately, it added.

The four products are promethazine oral solution, Kofexmalin and Makoff cough syrups, and Magrip N cold syrup, all pediatric medicines distributed in Gambia and manufactured by the Indian firm Maiden Pharmaceuticals Limited.

According to WHO, some tests have detected “unacceptable” amounts of diethylene glycol and ethylene glycol.

The use of these substances can cause abdominal pain, vomiting, diarrhea, inability to urinate, headache, altered mental state and acute kidney injury that can cause death, WHO explained.

WHO chief Tedros Adhanom Ghebreyesus said Wednesday in a statement that these four medicines were potentially linked to acute kidney injury and 66 deaths among children.

While the Indian government said that Maiden Pharmaceutical’s four drugs are manufactured for export only, and for the time being these four have only been found in Gambia, WHO has warned that they may have been distributed, through informal markets, to other countries or regions as well.

India, which has not confirmed the link between these drugs and the deaths, has underlined the need for the importing country to carry out adequate testing and ensuring the quality of products before allowing their consumption.

Maiden Pharmaceuticals, which has been operating for more than 30 years, has two plants in the country, both in the northern state of Haryana, for the production of capsules, injections, liquid syrup, ointments and tablets that are sold in countries in Asia, Africa, and Latin America, according to the company.

According to government records, the pharmaceutical company has been questioned on at least six occasions between 2008 and 2022 over batches of medicines that did not meet the required quality standards.

The large scale production of low-cost generic drugs and bulk active components has made India known as “the pharmacy of the world,” with the largest number of production plants approved by the Food and Drug Administration (FDA), after the United States. EFE


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