All pharmaceutical products from India exported to The Gambia will have to undergo document verification, physical inspection and quality control testing before shipment from July 1, reported Reuters.
The new inspection rules, which only applies to India for now, comes after at least 70 children had died in the West African country last year due to acute kidney injury, which the doctors had linked to adulterated cough syrups from India.
In October, the World Heath Organization had issued a global alert for four cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by Haryana-based Maiden Pharmaceuticals.
The world health body had said that its laboratory analysis of the syrups confirmed that they contained dangerous levels of toxins known as diethylene glycol and ethylene glycol.
In December, a parliamentary report submitted by The Gambia’s government had confirmed that Maiden’s syrups were linked with acute kidney failure in children.
On June 15, the executive director of The Gambia Medicines Control Agency, Markieu Janneh Kaira, wrote to India’s drug controller general Rajeev Singh Raghuvanshi, saying that the latest move is to “address issues related to substandard and falsified [counterfeit] medicines entering the country”, reported Reuters.
The Gambian drug controller has appointed Quntrol Laboratories, an independent inspection and testing company for pharmaceuticals based in Mumbai, to issue a Clean Report of Inspection and Analysis for all shipments from India.
Quntrol Laboratories will conduct document verification, physical inspection of the consignment and analysis of the samples, according to the new rules.
“If conformity is established at all levels, Quntrol shall issue the mandatory CRIA [Clean Report of Inspection and Analysis] document,” the letter said. “If conformity is not established with regards to the quality of the product, the shipment will be quarantined or seized by the MCA [Medicines Control Agency] and the necessary regulatory actions shall be taken.”
The new guidelines also require pharmaceutical firms to register as exporters to The Gambia by filing out company details, providing a copy of manufacturing licence along with a copy of World Health Organization’s Good Manufacturing Practices certificate, reported The Indian Express.
The companies will also have to provide information of the Gambian importer, get their manufacturing and warehouse sites inspected, and pay a one-time non-refundable fee of Rs 20,000.