.... “Laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal,” WHO said.
Dr. Wilhelmina S. Jallah, Liberia’s Health Minister, has warned the general public to be on the alert for four contaminated medicines (cough syrups) linked to the deaths of 66 children in The Gambia. According to her, the Gambian authorities, on July 20, 2022, discovered increased cases of acute kidney injuries among children after sending samples to Senegal and Ghana.
Making the disclosure on October 10, following the celebration of World Mental Health Day, Jallah informed the general public that the World Health Organization (WHO) has issued a global alert (N0. 6/2022) that four contaminated medicines are potentially linked to acute kidney injuries.
According to the WHO, the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.
“Laboratory analysis of samples of each of the four products confirm that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal,” WHO said.
Even worse, these contaminants are odorless and colorless and are not listed on the packaging of the respective cough medicines. This makes them impossible to detect, without detailed laboratory analysis or until the toxic effects start to manifest. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.
The WHO’s intervention came after medical authorities in The Gambia — a popular tourist destination in West Africa — detected an increase in cases of acute kidney injury among children under the age of five in late July.
The Gambian government has since suspended the use of all paracetamol syrups and has urged people to use tablets instead.
Jallah said upon hearing about the contaminated cough syrups, she immediately contacted the Liberia Medicines and Health Products Regulatory Authority (LMHRA) with details of medicines and health products. She said the LMHRA leadership officially informed the MOH that none of the products in question were registered by the LMHRA in its database.
She also indicated that the MOH is working in collaboration with the Pharmacy Board of Liberia and professional health bodies to widely disseminate the WHO alert.
The Health Minister, who could not confirm whether these contaminated medical products are in Liberia, disclosed that the adverse reactions to said products include but are not limited to toxic effects, abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental states, and acute kidney injury that may lead to death. According to her, the WHO recommended that countries including Liberia take these products out of circulation to prevent further harm.
“The MOH has informed the 15 county health teams to further inform all health service delivery points (hospitals, health centers, clinics, and community health teams),” she said.
Jallah further advised the general public to report any other named products to the LMHRA to intervene to remove and dispose of them.
Over the weekend, Maiden Pharmaceuticals said it was “shocked to hear the media reports regarding the deaths and [is] deeply saddened on this incident but we received the official information from our agent at the Gambia on October 5, 2022, and on the subsequent date, World Health Organization alert was issued against us.”
In an official statement, the company’s director, Vivek Goyal, said, “We are in the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General (India) and the State Drugs Controllers, Haryana,” the statement said.
“The government agencies visited our factory on October 1 and October 3, October 6 and 7 October and the samples were drawn by the Central Drugs Standard Control Organisation (CDSCO) along with all relevant documents in question in presence of our directors," Goyal said in the statement.
However, major Indian news media outlet, India Today, reported that Maiden Pharmaceuticals Limited has a track record of producing substandard drugs and that the company “flouted norms in four states” in India. The article also highlights public concerns about the functioning of India’s national pharmaceutical regulator, Central Drugs Standard Control Organization (CDSCO), as well as the pre-qualification process of the WHO.
“To date, these four products have been identified in The Gambia, but may have been distributed, through informal markets, to other countries or regions,” WHO says.
Maiden Pharmaceuticals currently exports to six West African countries, including Côte d’Ivoire, Senegal, Benin, Niger, Nigeria, Burkina Faso.
India is the largest provider of generic drugs globally and is known for its affordable vaccines and generic medications. Generic drugs account for 20% of the country’s global export in terms of volume, making India the largest provider of generic medicines globally.
Generic medicines help save patients and hospitals billions of dollars every year, equivalent to at least two-thirds of prescription costs, according to WebMD. This is where India has positioned itself as a major contributor to the objective of reducing healthcare costs in regions like Africa and Latin America.
The Indian Pharmaceutical industry is currently ranked third in pharmaceutical production by volume in 2022, exporting to more than 200 countries in the world, with the U.S. being the key market, according to the India Brand Equity Foundation (IBEF). IBEF is a Trust established by the Department of Commerce, Ministry of Commerce and Industry, Government of India. IBEF's primary objective is to promote and create international awareness of the ‘Made in India’ label in markets overseas and to facilitate the dissemination of knowledge of Indian products and services.