Gambia tightens rules for Indian drugs after cough syrup deaths

Months after made-in-India cough syrups killed children in Gambia, the health authorities in the African nation have decided to test all Indian medicine consignments before exports to ensure supply of good quality drugs.

The Gambian authorities informed that they appointed a firm to do the inspection and checking for all pharmaceutical consignments from July 1.

This will be in addition to the quality control mechanism set up by CDSCO last month to check the quality of medicines exported to other countries.

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In a letter to the DCGI, the Medicines Control Agency of The Gambia said it introduced a new set of regulations of pre-shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis for pharmaceuticals to address issues related to substandard and counterfeit medicines entering the country.

The new 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, an independent verification, inspection and testing company in Mumbaj to carry out the process and issue clean certificates for all shipments.

"All shipments arriving in Gambia with the bill of lading on or after July 1, 2023 will be required to provide the CRIA for customs clearance at the ports of entry in The Gambia" said the letter sent to Rajeev Singh Raghuvanshi, Drugs Controller General of India last week.

Gambia is the first country to demand such a pre-shipment certification from an independent agency without relying solely on the CDSCO.

This comes just a month after the Union government revised a section of the export policy making it compulsory for cough syrups to be cleared for export only after a screening test and production of a certificate of analysis from one of the laboratories identified by the government.

India's industry supplies nearly half of the pharmaceuticals used in Africa. In April, India said its officials had held meetings in Africa to ensure its drug exports did not suffer after at least 70 children died in Gambia after consuming the cough syrup last year

In recent months, there have been multiple World Health Organisation alerts in which the UN body red flagged contamination by diethylene glycol and ethylene glycol, chemicals that are toxic to humans when consumed and can prove fatal.

Such contaminated syrups, made by Indian pharmaceutical companies, were reportedly linked to children’s deaths in The Gambia in October and Uzbekistan in December. Last month, the WHO reported made-in-India cough syrups being sold in Marshall Islands and Micronesia with an “unacceptable level” of two contaminants that are not safe for human consumption.