Contaminated drugs in Gambia: the scandalous Indian denial

After the death of 69 Gambian children contaminated by a cough medicine imported from India, New Delhi declines all responsibility, based on highly questionable reports.

At the beginning of last October, the World Health Organization (WHO) launched an “alert” concerning four medical products “of inferior quality”, that is to say that do not meet quality standards. Among these are two cough syrups for babies. All produced by the Indian laboratory Maiden Pharmaceuticals Limited. “To date, the declared manufacturer has not provided any guarantee to the WHO on the safety and quality of these products”, indicated the world organization at the time.

And for good reason: at the end of July, The Gambia detected a strange increase in cases of acute kidney injury in children under 5 years old. The toll had been terrible: 69 children had died of these injuries, according to official figures. Perhaps much more in reality.

India reacted immediately by announcing the opening of an investigation into the products concerned. Imposing also the cessation of production from its factory to the laboratory. Before assuring the WHO that the samples tested had not revealed any contamination. A group of Indian experts was then mandated to continue the analyses.

The WHO will not publish its reports

Finally, the report of these experts went in the same direction as that of the Indian government. Not satisfactory for the WHO, which decided to refute the conclusions of the experts: the Drugs Controller General of India (DCGI) saw the report arrive on his desk on January 24, stating that there was no demonstrated link between the deaths of Gambian children and the products pointed out by the WHO. . But neither the Indian government nor the DCGI want to communicate the results of the analyzes.

However, the conclusions contradict the tests ordered by the WHO, which revealed contamination of the drugs sold by Maiden by two toxins – diethylene glycol (DEG) and ethylene glycol (EG) – concerning four samples out of the 23 tested. 

Glycol is a viscous liquid typically used for cooling systems, such as radiators. Similar cases of the presence of glycol in drugs have been recorded previously in India, the United States, Bangladesh and Panama. In Africa, Nigeria has also had to deal with such a scandal. India sees, in the Gambian case, "an attempt to tarnish the image of India" and its pharmaceutical sector.

The liability of Maiden Pharmaceuticals in question

But why the WHO, with the exception of having reiterated its warning against the drugs produced by Maiden, does not publish the results of these tests?

according to The Wire, the WHO is accused of not making sure to prove the link of cause and effect in this case. The global institution relies on “the International Health Regulations”, indicating that if it provides “technical support” in the investigations, it will not publish the results “without the authorization of the government of Gambia”. And the WHO to refer the responsibility for this clinical evaluation to the Gambian Minister of Health.

It is therefore, for two weeks, the total imbroglio in this file: the Indian government claims to have had no report on the causal links between Maiden's drugs and the deaths of Gambian children. But the WHO tells him that it is by contacting the Gambian government that he will find the answers to his questions. Finally, a report by a Gambian parliamentary commission attributes responsibility for the deaths to Maiden Pharmaceuticals.

Recently, in Uzbekistan, 18 children are said to have died after consuming drugs made in India. Again, India had demanded evidence and reports, ensuring not to be responsible.

The complaint against Maiden Pharmaceuticals does not see the light of day

Still, Maiden Pharmaceuticals is not at its first scandal: the Indian laboratory was already on several blacklists, in India, but also internationally – in Vietnam for example – for not having met the standards in force. Drugs from the laboratory have also repeatedly failed quality control tests.

Several months after the start of the case in The Gambia, where are we? The parliamentary report believes that "the government must take legal action against Maiden Pharmaceuticals for exporting contaminated drugs to The Gambia". The Gambian President, Adama Barrow, assured that he wanted to "shed light" on the responsibilities. But a complaint would not be in the pipes. The presidency would like to create a “national laboratory for the quality control of medicines and food safety”. But, as Médecins sans frontières (MSF) warns, the responsibility should not lie exclusively with importing countries. However, the Indian authorities are today in denial, despite the death of several dozen Gambian children.