Gambia will enforce new regulations starting July 1, requiring all pharmaceuticals products from India to undergo rigorous inspection and testing prior to shipment.
This decision is a response to the deaths of numerous children linked to Indian-manufactured cough syrups. It signifies a broader trend among governments reevaluating their reliance on India’s $42 billion pharmaceutical industry since the contamination scandal emerged last year. Notably, India supplies nearly half of the pharmaceuticals used in Africa.
In a letter dated June 15, Markieu Janneh Kaira, the executive director of Gambia’s Medicines Control Agency (MCA), conveyed the country’s intention to address issues related to substandard and counterfeit medicines.
Kaira stated, “This is to address issues related to substandard and falsified (counterfeit) medicines entering the country.” The letter was addressed to India’s drug controller general, Rajeev Singh Raghuvanshi.
The letter further revealed that the MCA had enlisted the services of Quntrol Laboratories, an independent inspection and testing company based in Mumbai. Kaira explained, “Quntrol shall conduct document verification, physical inspection of the consignment and sampling, for laboratory testing for each shipment.” Quntrol Laboratories will be responsible for issuing a Clean Report of Inspection and Analysis (CRIA) for all shipments from India.
Kaira emphasized that if the products meet the required standards at all levels, Quntrol will issue the mandatory CRIA document. However, if any non-compliance is detected regarding product quality, the shipment will be quarantined or seized by the MCA, and appropriate regulatory actions will be taken.
Markieu Janneh Kaira confirmed that these rules currently only apply to India. He stated, “This applies to India for now only.” From June 1, India has already made it mandatory for all cough syrups to undergo tests before being exported.
Rajeev Singh Raghuvanshi, the Indian drug controller general, has yet to respond to Reuters’ request for comment. However, he did address Indian state regulators in a letter posted on the website of India’s Central Drugs Standard Control Organisation, urging them to take note of Gambia’s new guidelines. Raghuvanshi stated, “This is for your information and immediate action.”
Gambia, with its population of 2.5 million, is one of Africa’s smallest and poorest countries. Although a testing laboratory funded by the World Bank is being established in Gambia, it is not yet operational.
The letter specified that Quntrol would send samples for testing to an analytical laboratory approved by the MCA, without indicating whether the laboratory would be based in India or elsewhere.
In 2022, a tragic incident occurred in Gambia, where at least 70 children, mostly under the age of five, lost their lives due to acute kidney injury caused by contaminated cough syrups from India.
The World Health Organization reported that these India-made cough syrups contained lethal toxins, including ethylene glycol and diethylene glycol, substances commonly found in car brake fluid and unsuitable for human consumption.
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Manufacturing experts explained that unscrupulous actors could use these toxic ingredients as substitutes for propylene glycol, a key component of syrupy medicines. They noted that the motivation behind this substitution is the significantly lower cost of ethylene glycol and diethylene glycol, which can be less than half the price of propylene glycol.
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