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India investigates cough syrups after child deaths in Gambia

A cameraman takes visuals outside the office of Maiden Pharmaceuticals Ltd. company, in New Delhi, India, October 6, 2022. (Photo by Reuters)

Indian authorities have launched investigation into cough syrups made by a local pharmaceutical company after the World Health Organization blamed them for the deaths of 66 children in the West Africa country of Gambia.

The death of 66 children in the Gambia could deal a major blow to the credibility of medicines produced in India, a country known as the "pharmacy of the world".

The WHO announced this week that laboratory tests on four products by Indian pharmaceutical company Maiden - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup - found unacceptable levels of diethylene glycol and ethylene glycol, which can be toxic and contain lead that can cause severe kidney injury.

Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and some other industrial applications. But these items can also be used as a cheaper alternative in some pharmaceutical products instead of glycerin, a solvent or thickening agent in many cough syrups.

India's Health Ministry has announced that samples of all four cough syrups exported to Gambia have been sent to a federal laboratory for further investigation, and the results can clarify the recent reports of the World Health Organization.

It asked the WHO to share its report on establishing a cause-and-effect relationship with deaths from the medical products in question.

Margaret Harris, spokesperson of the World Health Organization, said that the reports of the director of the Central Agency for Drug Control and Standards of India and Maiden show that officials have visited the factories of the company to investigate various aspects of the incident, and the WHO is waiting for the results of their findings.

Anil Vij, health minister of Haryana state, where the cough syrup factory is located, has warned of strict action if any mistake is found after the tests.

WHO Director-General Tedros Adhanom Ghebreyesus told reporters on Wednesday that the agency is investigating the causes of death from acute kidney injury caused by the use of Indian drugs.

The agency notified India's Drug Controller General of the deaths late last month, after which the regulator launched an investigation with government officials along with the WHO.

Naresh Kumar Goyal, a Maiden director, said the company heard the news of the children's deaths on Thursday morning and was investigating to find out the details of the incident.

"We are trying to find out the situation because it cropped up only today," he said.

"We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India." He declined to speak further.

India's Health Ministry said that Maidan Pharmaceutical Company, which started its activity in the field of drug production in November 1990, manufactures and exports the cough syrups only to Gambia.

This Indian pharmaceutical company has the annual production capacity of 2.2 million bottles of syrup, 600 million capsules, 18 million injections, 300,000 tubes of ointment and 1.2 billion tablets.

Maiden wrote on its website that it sells its products domestically and exports them to countries in Asia, Africa and Latin America. But Goyal said they were currently not selling the products within India.

India's Health Ministry announced that countries that import pharmaceutical products usually conduct necessary tests on them before granting permission to use a drug.

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