Indian medicine manufacturer Maiden Pharmaceuticals should be held responsible for exporting the cough syrups linked to the deaths of over 66 children in The Gambia, a select committee set up by the West African country’s Parliament said in a report on Tuesday.
“The government should pursue legal action against Maiden Pharmaceuticals for exporting contaminated drugs to The Gambia with the Atlantic brand name,” the panel told Parliament, known as the National Assembly in The Gambia, after conducting an investigation into the deaths.
The panel also recommended that the Indian drug maker should be blacklisted and its products be banned in The Gambia.
The development came two months after the World Heath Organization issued a global alert for four cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by Maiden Pharmaceuticals.
Authorities in the West African country had linked the deaths of over 66 children, most of them due to acute kidney failure, to these medicines.
In its report to the National Assembly, the panel said that the Maiden Pharmaceuticals’ four cough syrups imported by Atlantic Pharmaceuticals were analysed in Switzerland by the global body and found to “contain unacceptable levels of diethylene glycol and ethylene glycol”. Diethylene glycol and ethylene glycol are common impurities in cough syrups.
“These contaminates are toxic and have been linked to the acute kidney injury that killed the 66+ children,” the report said.
The panel, however, ruled out Atlantic Pharmaceuticals’ role in the deaths, stating that the investigation showed the company followed all regulations for importing medicines, including the batch that had the contaminated syrups.
According to the report, the contaminated products were imported in June, the same month the outbreak of the acute kidney injury started.
For its inquiry, the panel spoke to 16 organisations and experts, including the drug regulator, pharmaceutical council, press union, medical consultants and the pharmacy college. It also conducted spot checks of 16 medicine importers, including Atlantic Pharmaceuticals.
“It is a quality assurance failure on the part of the manufacturer,” said an expert team of the West African Post Graduate College of Pharmacists.
The team said that raw materials are quarantined upon arrival in factories and released following quality control inspection. It said that the samples are further tested for quality before final product is certified again with a label indicating contents and quantities.
“It is obvious this was not done for the contaminated products,” the team said, according to the report. “The manufacturer did not follow Good Manufacturing Practice.”
The panel also said that it tried contacting Maiden Pharmaceuticals, but the company did not respond to calls or emails.
In India, however, the testing of the samples of the cough syrups had found the drugs were not contaminated with diethylene glycol or ethylene glycol, according to a letter written by Drugs Controller General of India VG Somani to Rogerio Gaspar, the director (regulation and prequalification) at the World Health Organization, on December 13.
According to the letter, India had sought details from the World Health Organization about the causality relationship between drugs manufactured in the country and the deaths in The Gambia but no information has been exchanged so far.
Following this development, Maiden Pharmaceuticals had said on December 16 that it would seek permission to reopen its factory in Sonepat.
The Haryana government had suspended drug manufacturing at Maiden Pharmaceuticals’ Sonipat unit soon after the global health body’s alert, following a joint inspection by the Central and state drug departments that found 12 flaws in the medicines and their manufacturing process.
However, on December 16, Union Minister of State for Health and Family Welfare Bharati Pravin Pawar had told Parliament that Maiden Pharmaceuticals manufacturing operations will remain shut for now due to other violations.