The Gambian deadlock: India's drug authority rejects Gambia panel's claim of child deaths from Maiden Pharma drug

A Parliamentary panel of the National Assembly of Gambia has reiterated the accusation that consumption of contaminated medicines sourced from India's Maiden Pharmaceutical Ltd is linked to acute kidney injury related deaths of at least 70 children in that country. However, it adds that the factual cause of death of these children is still under scientific investigation as causality tests are currently being undertaken by the Ministry of Health and partners.

The inquiry report of the Select Committee on Health, Disaster, Refugees and Humanitarian Relief, of Gambia's Parliament was released on December 20, days after the Drugs Controller General of India (DCGI) ruled out contamination possibilities in the four products Maiden Pharma supplied to Gambia.

The inquiry report points out that the preliminary test reports of 9 drug samples tested, found that 8 samples (89%) had propylene glycol detected, 2 (22%) contained Ethylene glycol (EG) and 1 sample (11%) contained Diethylene glycol (DEG). Further analysis from the Switzerland laboratory showed the proper quantities of these compounds (which turned out to be unacceptably high), the report says.

The report accused Maiden Pharma of not following the good manufacturing practices (GMP). "It is a quality assurance failure on the part of the manufacturer. All raw materials for production on arrival in a factory are quarantined and released only when quality control certifies the material as having met the required standard. Sampling is carried out at every stage of the production process for quality control till the final product. The final product is certified again with a label indicating contents and quantities. It is obvious this was not done for the contaminated products. The manufacturer did not follow Good Manufacturing Practice (GMP)," the report said. The Select Committee further said it is convinced that Maiden Pharmaceuticals Ltd is culpable and wanted the company to be held accountable for exporting the contaminated medicines that linked to the death of at least 70 children in The Gambia in 2022.

Meanwhile, in a letter to the World Health Organisation (WHO) on December 13, India's drug regulator DCGI stated that the sample of all four products in question was sourced from Maiden Pharma and sent for quality testing to government laboratory. The results said that the products were found to be complying with all specifications. "DEG and EG were not found to be detected in these products," it said. As regards to the use of propylene glycol, DCGI said the sample of this expedient available at the manufacturing site at the time of inspection was also sampled and tested and found to be complying with quality specifications. The DCGI letter suggests that these medicines would not have been the primary cause of death.

The shadow of doubts will remain until Gambian health authorities publishes the causality test results that throws more light on the actual cause of deaths.