IN the wake of a government-backed investigation revealing that contaminated medicines from India were ‘very likely’ responsible for the deaths of at least 70 children last year, Gambia has engaged the services of a US law firm to assess potential legal action, according to Justice Minister Dawda Jallow, in an exclusive statement provided to Reuters. The move marks the first indication of possible international litigation relating to the tragic deaths. Minister Jallow did not disclose the target of any potential legal proceedings or the identity of the law firm involved.
Earlier this year, local doctors in Gambia expressed suspicions that cough syrups imported from India were the probable cause of the fatalities, predominantly affecting children under the age of five. Tests conducted by the World Health Organisation (WHO) subsequently confirmed the presence of lethal toxins, prompting a worldwide investigation into contaminated medicines. The justice minister revealed that legal action was among the options under consideration by the Gambian government.
The medicines implicated in the children’s deaths were manufactured by Indian drug maker Maiden Pharmaceuticals, which has vehemently denied any wrongdoing. WHO tests revealed that the Maiden cough syrups contained diethylene glycol (DEG) and ethylene glycol (EG), toxic substances typically found in car brake fluid. The Indian government stated that its own tests on the drugs did not detect any toxins.
Requests for comment regarding Gambia’s potential legal action from India’s health ministry and Maiden Pharmaceuticals went unanswered. The WHO declined to provide a statement on the matter.
Indian officials have previously challenged the WHO’s assertion of a causal link between the deaths in Gambia and India’s pharmaceutical industry, accusing the agency of undermining the nation’s $41bn drug sector. However, another Indian drug manufacturer’s cough syrups were implicated in the deaths of 19 children in Uzbekistan. Subsequently, India introduced mandatory drug testing for cough syrups prior to export.
Gambia’s justice ministry is currently evaluating its options following the completion of a newly commissioned causality assessment by an international panel of experts, Minister Jallow confirmed. Although the report has not been made public, Reuters has obtained a copy. The assessment examined 56 cases of acute kidney injury, concluding that 22 of them were ‘very likely’ caused by DEG or EG poisoning resulting from the consumption of Maiden products. In an additional 30 cases, the panel found evidence ‘highly suggestive’ of DEG and EG as the cause of death. Insufficient evidence was available for four other cases. Autopsies were conducted on only two patients, both of which showed pathology consistent with DEG and EG poisoning. The report further revealed that among all the medicines tested after the deaths, only Maiden’s products exhibited toxicity.
Several experts in pharmaceutical manufacturing noted that unscrupulous actors may employ DEG and EG as a cheap substitute for propylene glycol, a crucial ingredient in syrup-based medications.
The involvement of Maiden’s drugs in the deaths sparked an extensive investigation into India’s drug sector and the oversight of pharmaceutical raw materials on a global scale, raising concerns among international health officials about lax regulation. Many countries, including Gambia, which receive supplies from India lack the means to test imported drugs.
The WHO continues to investigate the origin of contaminated cough syrups in Gambia, Uzbekistan, and other countries. However, the lack of information regarding Maiden’s drugs has hindered progress. Reuters discovered that a crucial middleman in the supply chain for these medicines remains unidentified.
Minister Dawda stated that the causality assessment and the recommendations from the justice ministry would be made public within six months. Gambia plans to establish a drug testing facility for imported medicines with the support of the World Bank, as confirmed by the bank to Reuters.