Gambia Implements Stricter Rules for Indian Drugs Following Cough Syrup-Related Deaths

Wed Jun 21 2023
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BANJUL: The Gambian government has introduced new regulations requiring mandatory inspection and testing of all pharmaceutical products from India before shipment, starting from July 1 this year.

These restrictions, outlined in Gambian government documents, as reported by Reuters, are the first known measures taken by a country to limit national exports following the deaths of numerous children connected to Indian-made cough syrups.

The move highlights a growing concern among governments about their reliance on India’s $42 billion pharmaceutical industry since the contamination issue emerged last year. India currently supplies nearly half of the pharmaceuticals utilized in Africa. In response to the deaths of at least 70 children in Gambia last year due to consuming the contaminated cough syrup, India’s government held meetings in Africa in April to ensure the continuity of its drug exports.

Gambia Aims to Control Counterfeit Medicines

Gambia’s decision to tighten regulations aims to address issues related to substandard and counterfeit medicines entering the country, according to a letter dated June 15 from Markieu Janneh Kaira, the executive director of Gambia’s Medicines Control Agency (MCA), to India’s drug controller general, Rajeev Singh Raghuvanshi. The MCA has appointed Quntrol Laboratories, an independent inspection and testing company based in Mumbai, to issue a Clean Report of Inspection and Analysis (CRIA) for all shipments from India.

The letter states that Quntrol will conduct document verification, physical inspection of the consignment, and sampling for laboratory testing of each shipment. If conformity with quality standards is established, Quntrol will issue the mandatory CRIA document. However, if conformity is not established, the shipment will be quarantined or seized by the MCA, and appropriate regulatory actions will be taken.

While the new rule currently applies to India only, as confirmed by Janneh Kaira, India has already made testing mandatory for all cough syrups exported since June 1. Rajeev Singh Raghuvanshi has requested Indian state regulators to take note of Gambia’s guidelines, as mentioned in a letter posted on the Central Drugs Standard Control Organisation’s website on Wednesday.

Gambia, with a population of 2.5 million, is one of Africa’s smallest and poorest countries. The World Bank is funding a testing laboratory in Gambia, which is currently under construction.

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