New Delhi, Oct 12 (EFE).- The Indian authorities have ordered the suspension of drug production at a factory, which the World Health Organization (WHO) has associated with the death of more than 60 children in the Gambia, officials said Wednesday.
The move comes after after regulatory authorities, together with regional bodies, inspected one of the manufacturing centers of the plant belonging to Maiden Pharmaceuticals Limited in the state of Haryana, regional health minister Anil Vij told ANI news agency.
During the joint inspection, the authorities discovered numerous lapses in good practices and decided to stop total production and issued a warning to that effect, he said.
According to Vij, the authorities have also taken samples of the three medicines produced at the Sonipat plant, and sent them to the Central Drugs Laboratory in the city of Kolkata, the government research center for drug quality control.
The WHO last week reported suspicions of “unacceptable” amounts of diethylene glycol and ethylene glycol, two toxic agents, in four drugs manufactured by Maiden Pharmaceuticals.
The four products are promethazine oral solution, Kofexmalin and Makoff cough syrups, and Magrip N cold syrup, all pediatric medicines distributed in Gambia.
The WHO said the contaminants in these drugs are potentially linked to acute kidney injury and at least 66 children deaths.
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