Gambia tightens quality checks on medicines from India

The drug regulator of The Gambia, the Medicines Control Agency (MCA), has tightened the quality inspection mechanism for imported medicines in the wake of child deaths due to the consumption of contaminated cough syrups. The cough syrups were shipped to The Gambia from India by Delhi-based Maiden Pharmaceuticals.

The agency has introduced the regulation of pre-shipment document verification, physical inspection, quality control testing, and issuance of Clean Report of Inspection and Analysis (CRIA) for pharmaceuticals to address issues related to substandard and falsified (counterfeit) medicines entering the country, Markieu Janneh Kaira, executive director, MCA, informed.

The regulation will be implemented from July 1. All shipments arriving into The Gambia with a bill of lading dated on or after that date will be required to provide the CRIA for customs clearance at the Porls of Entry in The Gambia.

In a letter to the Drugs Controller General of India Dr Rajeev Singh Raghuvanshi, Kaira said this regulation requires all imported pharmaceutical products to be inspected and sampled for testing to ensure conformity to quality standards prior to shipment from India.

The MCA has appointed Quntrol Laboratories Private Limited, an independent verification, inspection, and testing company, to carry out the process and issue CRIA for all shipments. An importer will require a CRIA issued by Quntrol to clear their goods at the Ports of Entry in The Gambia, the letter informed.

Last year, the inquiry report of the Select Committee on Health, Disaster, Refugees and Humanitarian Relief of the Gambia’s Parliament had said that Maiden Pharmaceuticals Ltd should be held accountable for exporting the contaminated medicines that were linked to the death of at least 70 children in The Gambia 2022.

Early this year, the US Food and Drug Administration (USFDA) recommended testing of samples from all containers of all lots of high-risk drug components like glycerin and propylene glycol before it is used in the manufacture or preparation of drug products. The advisory comes after dozens of deaths were reported from Gamiba and Uzbekistan after children consumed cough syrups with high levels of diethylene glycol (DEG) and ethylene glycol (EG) that were supplied by some Indian manufacturers.