New Delhi: An US Centers for Disease Control and Prevention (CDC) investigation has now found that contaminated medications made by India-based Maiden Pharmaceuticals were “associated” with the deaths of 70 children in Gambia that took place between August and December last year. The US-CDC report was published on March 3.
This is the third report to link the four cough syrups to the acute kidney injuries among children of the West African country last year. These injuries led to their deaths. Earlier, The Wire had reported that the WHO had found diethylene glycol (DEG) and ethylene glycol (EG), two industrial chemicals, in huge quantities in the four paediatric formulations — ranging from 1.0%-21.30%.
A Gambian parliamentary probe had concluded that Maiden Pharmaceuticals was ‘culpable’ of the deaths and ‘should be held accountable’.
The Indian government, had, however, cleared the name of the firm in the incident after testing control samples of the same batch that was exported to Gambia. It found no contamination in them. However, the WHO had refused to accept this report and issued a renewed alert against the four products in question, in January this year. It had issued the first product alert last October.
The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The US-CDC report now says, “This investigation strongly suggests that medications contaminated with DEG or EG imported into The Gambia led to this AKI [acute kidney injury] cluster among children.”
One of the authors of this report, Peter Adewuyi, told The Wire, “If the Indian government thought that the report coming from the Gambian parliament was a political one, here is another scientific piece of report that has come from the US-CDC.”
He added, “We hope that the India government reconsiders its stand and reopens the investigation into the case so that culprits are punished.” Adewuyi is a member of the Gambian Field Epidemiology Training Program and African Field Epidemiology Network.
There has been no response from the Indian health ministry since the publication of the US-CDC report. In December 2022, India’s health minister Mansukh Mandaviya had called the reports pointing out the contamination a bid to sully India’s image as the ‘pharmacy of the world’.
The CDC report also has another important finding. It says that while mass DEG poisoning incidents have happened in the past in places like Panama, Nigeria, India, and Haiti, but in all these past events, the suspected drug(s) were made in these respective countries itself.
“Among reports of AKI associated with DEG-contaminated medical products, this is the first in which DEG-contaminated medications were imported into a country, rather than being domestically manufactured,” the report said.
The authors, quoting some previous analyses, said this incident highlighted the failures of the regulatory system to monitor the quality of drugs meant for export. The regulatory authority in this case is India’s drug regulator Central Standards Drugs Control Organisation (CDSCO).
“Medications for export might be subject to less rigorous regulatory standards than those for domestic use,” the report said. Incidentally, Maiden Pharmaceuticals has been flagged earlier also for exporting substandard medicines. Vietnam had blacklisted the firm in January 2011, and also 45 other Indian companies, allegedly over substandard quality of medicines.
The US CDC report added, “Inadequate regulatory structures make the sale of medications from international markets an especially high-risk activity in low-resource settings [like Gambia]…Simultaneously, low-resource countries might not have the human and financial resources to monitor and test imported drugs.”
The US-CDC team found from treating physicians at the teaching hospital that caregivers had administered paracetamol and promethazine to their children before the kids developed of kidney ailments – something that even the probe of Gambian parliamentarians had concluded.
The Indian government gave no response at all to the detailed Gambian parliamentary report which came in December last year. Itwas prepared by speaking to 16 stakeholders, including Gambian and other African scientific institutions.
To rule out any other causes, the US-CDC team asked the caregivers not just about the recent medical history but also other possible exposures, including “medications, foods, and experience of flooding, among others” that might have led to the poisoning. The team reached the conclusion that the four Maiden Pharmaceuticals-made medicines were associated with the deaths.
A little less than half of the interviewees told the US-CDC team that their children had consumed four or more medications before hospitalisation. Though many of the interviewees were not able to recall the names, half of them identified the manufacturer of at least one of the medications administered.
The US-CDC team consisted of an epidemiologist, an anthropologist, an infectious disease physician, and an environmental health scientist. The team conducted interviews of the parents whose kids succumbed to kidney injuries and also reviewed medical records of the patients.
While talking to The Wire on March 3, Adewuyi repeated his claim that he had made to us in December last year. “The time the cough syrups were withdrawn from the market [in October] and house-to-house recall initiated, the number of deaths started stabilising [which were increasing on a weekly basis otherwise].”
Asked how one could reconcile the findings of the Gambian parliamentary report and the WHO-commission lab investigation which found large-scale contamination to the Indian government’s findings that there was none, Adewuyi said that this was something that the Indian government had to look into.
“How is it possible that the samples tested by a WHO-accredited lab found toxins and for the same batch the Indian investigation did not? Did the Indian government inspectors collect the samples from the same batch [which were sent to Gambia and tested by the WHO],” he questioned.