Gambia has hired a US law firm to explore legal action after a government-backed investigation found that contaminated medicines from India were “very likely” to have caused the deaths of children last year, the justice minister said.
At least 70 children in Gambia, most under fiver years old, died from acute kidney injury between June and October.
Local doctors suspected cough syrups imported from India were the likely culprit, Reuters reported earlier this year, and tests by the World Health Organization (WHO) confirmed the presence of lethal toxins, sparking a global hunt for contaminated medicines.
Gambian justice minister Dawda Jallow said legal action was one option under consideration by the government, the first sign of potential international litigation over the deaths. Jallow did not say who would be the target of potential legal proceedings or name the law firm hired to help.
The medicines linked to the children’s deaths were made by Indian drug maker Maiden Pharmaceuticals, which denied wrongdoing.
Tests by the WHO found that the Maiden cough syrups contained the lethal toxins diethylene glycol (DEG) and ethylene glycol (EG), used in car brake fluid. India’s government has said its own tests on the drugs found no toxins.
India’s health ministry and Maiden did not respond to requests for comment on Gambia’s possible legal action. The WHO declined to comment.
Indian officials have said the WHO failed to prove a causal link to the Gambia deaths, accusing the agency of denigrating its $41 billion pharmaceutical industry. However, cough syrups made by a second Indian drugmaker have been linked to the deaths of 19 children in Uzbekistan. India has since made drug testing mandatory for cough syrups before export.
Gambia’s justice ministry is considering its options after completion of a new government-commissioned causality assessment by a panel of international experts, Jallow said.
Reuters has seen a copy of the report, which was presented to President Adama Barrow in April but has not been made public.
In it, experts said they analysed 56 of the cases of acute kidney injury. Of those, they found 22 were “very likely” to have died from DEG or EG poisoning after taking Maiden products.
The panel could not confirm the cause of death in another 30 cases but said it was “highly suggestive” they were killed by DEG and EG. It said there was not enough evidence in four other cases.
Doctors were able to carry out autopsies on just two of the patients. The pathology from both was consistent with DEG and EG poisoning, the report said. Of all the medicines tested after the deaths, only Maiden’s were shown to be toxic, it said.
DEG and EG can be used by unscrupulous actors as a cheap substitute for propylene glycol, a key ingredient in syrupy medicines, according to several pharmaceutical manufacturing experts.
Reuters could not determine if Indian authorities had seen the causality report.
It is the latest piece of a months-long investigation into the deaths, which raised concerns among global health officials about lax regulation in India’s drug sector and oversight of pharmaceutical raw materials worldwide. Many of the countries India supplies, including Gambia, have no means of testing imported drugs.
The WHO has said it is continuing to investigate the source of contaminated cough syrups in Gambia, Uzbekistan and several other countries, but has been frustrated by a lack of information regarding Maiden’s drugs. A key middleman in the supply chain of those medicines is still unknown.
Gambia’s minister Dawda said the causality assessment and the justice ministry’s recommendations would be made public within six months.
Gambia is planning to build a testing facility for imported drugs with support from the World Bank, the bank said.