Explained: Gambian Committee¡¯s Findings On India¡¯s Drug Controller General¡¯s Claims

Indian pharmaceutical company, Maiden Pharmaceutical, has come under intense criticism after reports of its alleged link with the death of 70 children in the Gambia have come to the fore.

The opprobrium generated by the deaths of the children has caused the Indian government to take cognizance of the situation, act on it and for the Gambia to strengthen, inspect and regulate imported medicines.

The ¡®substandard¡¯ product

The World Health Organization(WHO) has stated that the India-manufactured cough syrup was ¡®substandard¡¯ and ¡®out of specification¡¯. The WHO further wrote- on 5th October 2022 when 66 deaths were recorded-¡¯the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products.¡¯

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The deaths in October led WHO Director-General Tedros Adhanom Ghebreyesus to conduct ¡¯further investigation with the company and regulatory authorities in India¡¯.

The Indian report

On December 16th, Hindustan Times wrote about the submission of the drug tests to the WHO by the drugs controller general of India, VG Somani. ¡®As per the test reports received from the government laboratory, all the control samples of the 4 products have been found to be complying with specifications.¡¯ Hindustan Times quoted Somani.

Somani further mentioned in the letter to WHO,¡¯ India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics.¡¯

The Indian investigation found no ¡®contaminants¡¯ allegedly mixed with the syrup. The contaminants being ethylene glycol and diethylene glycol in the exported batches.

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The Gambian report

But the analysis of the cough syrup samples in Switzerland had contaminants which exceeded the permissible levels and dismissed the claims made by Somani. ¡®We have received communication from India that they have done quality control testing for some of these medicines and they have found them fit. ¡­ but the tests that were done by the Gambia government with the help of WHO was done at WHO accredited labs and we hold by that.¡¯ said Amadou Carara, chairperson of a committee constituted by the Gambian government to look into the matter. The Indian Express reported.

The Gambian findings

The committee reported that children below the age of 3 figured 83% of the 82 reported cases of severe kidney injury. And almost 61% of the affected children were male.

The common symptom exhibited in the toddlers¡¯ was the inability to urinate despite lack of dehydration.
The paediatrician involved during the treatment observed a direct link between the period of consuming the cough syrup and the inability to urinate: the average period was three days.

The submission of the children¡¯s samples

The initial submission of the children¡¯s samples did reveal the presence of E.Coli. E.Coli, accordion to the WHO, is ¡®a bacteria that is commonly found in the lower intestine of warm-blooded organisms.¡¯ and ¡®affects young children and the elderly.¡¯

But, the deaths pinned on the solitary presence of the bacteria were rubbished by an expert who said that E.Coli cannot explain the sheer number of deaths. And ¡®lab reports showed very high levels of creatinine, liver enzymes, and uric acid inconsistent with children under the age of two.¡¯ Furthermore, the moment the syrups were discontinued, ¡®the cases stopped coming.¡¯ The Indian Express reported.

The suggestions of the committee

In the wake of the children¡¯s deaths, the Gambian committee, stressed,¡¯ the urgent need for a functional National Medicines Quality Control Laboratory¡¯; perform a thorough inspection of imported medicines; set up a vigilance unit dedicated to pharmaceuticals and undertake site visits of manufacturers.