Exclusive: Gambia tightens rules for Indian drugs after cough syrup deaths


From July 1, Gambian government documents reviewed by Reuters will require all Indian pharmaceutical products to be inspected and tested before shipment, the first known export restrictions following the deaths of dozens of children linked to Indian cough syrups.

Since last year’s pollution, nations are reassessing their dependence on India’s $42 billion pharmaceutical business, as shown by the new rule. India supplies approximately half of Africa’s medications. After at least 70 Gambia children died from cough syrup last year, India’s government held meetings across Africa to protect its medication exports in April.

Gambia’s Medicines Control Agency (MCA) executive director, Markieu Janneh Kaira, wrote to India’s drug controller general, Rajeev Singh Raghuvanshi, on June 15 to “address issues related to substandard and falsified (counterfeit) medicines entering the country.” The letter stated that the MCA had hired Mumbai-based Quntrol Laboratories, an independent pharmaceutical inspection and testing organization, to issue a Clean Report of Inspection and Analysis (CRIA) for all Indian imports.

“Quntrol shall conduct document verification, physical inspection of the consignment and sampling, for laboratory testing for each shipment,” the letter stated. Control will issue the CRIA if all levels are compliant. The MCA will quarantine or seize the package if the product quality does not meet standards.

Janneh Kaira told Reuters the law “applies to India for now only.” Before exporting cough syrups, India has required testing since June 1.

Raghuvanshi did not respond to an after-hours request for comment.

Gambia is Africa’s smallest and poorest nation, with 2.5 million people. Gambia’s World Bank-funded testing lab is incomplete. The letter stated that control would submit samples to “one of the analytical laboratories approved by MCA” for testing. The lab’s location was unknown.

Last year, Indian cough syrups caused acute renal disease in at least 70 Gambia children, most under 5. Last year, the WHO found fatal ethylene glycol and diethylene glycol in India-made cough syrups.

Manufacturing experts say unscrupulous actors can use these substances to replace propylene glycol, a fundamental foundation of syrupy medicines because they cost half as much.


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