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Gambian drug regulator to mandate pre-shipment inspection and certification for pharma products from India
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Gireesh Babu, New Delhi
June 22 , 2023
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The Medicines Control Agency (MCA), the national drug regulatory body of the West African nation the Gambia, is introducing a regulation of pre-shipment verification, inspection, quality testing and a clean report from a designated agency for pharmaceuticals from India to address issues related to substandard and falsified or counterfeit medicines entering the country, mandatory from July 1, 2023.
The move comes after the health authorities in the Gambia and the World Health Organisation (WHO) alleged last year that four cough syrups manufactured in India, for which the manufacturer is Haryana-based Maiden Pharmaceuticals, were linked with acute kidney injuries and death of 66 children.
MCA said that it has introduced the regulation of pre-shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis (CRIA) for the pharma exports to the Gambia to address the issue.
“This regulation requires all imported pharmaceutical products to be inspected and samples for testing to ensure conformity to quality standards prior to shipment from India,” said MCA in a letter issued to Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India on June 15, 2023.
The regulation will be implemented from July 1, 2023 and all shipments arriving into the country with a bill of lading dated on or after the date will be required to provide the clean report for customs clearance at the Ports of Entry in the Gambia, it added.
The regulatory agency has appointed Mumbai-based Quntrol Laboratories Pvt Ltd, an independent verification, inspection and testing company for pharmaceuticals, to carry out the process and issue CRIA for all shipments. The importer shall require a CRIA issued by Quntrol to clear their goods at the Ports of Entry in the Gambia, it added.
“Without this mandatory CRIA document, goods will not be accepted in the importation process,” it said. If confirmity is established at all levels, Quntrol shall issue mandatory CRIA documents and if conformity is not established with regards to quality of the product, the shipment will be quarantined or seized by the MCA and the necessary regulatory actions shall be taken, it is informed.
The DCGI has in turn referred the latter along with the guidance document from MCA to all State and Union Territory Drugs Controllers, manufacturers’ associations and Pharmaceuticals Exports Promotion Council (Pharmexcil) and for reference and immediate action.
According to the guidance document issued by the MCA, the exporter needs to first carry out one-time mandatory registration with Quntrol and raise an inspection request to the company online.
Quntrol will verify the documents related to the exports, conduct physical inspection and sampling on site, and testing of samples at MCA approved lab, before issuing CRIA for conforming the shipments. The importer needs to present the CRIA for import into the Gambia.
The exporters from India need to upload a copy of valid manufacturing license, WHO Good Manufacturing Practices (GMP) and WHO GMP certificates for the manufacturing sites along with product information. Once Quntrol checks information and approves the registration, the export shall pay a one-time non-refundable registration fee of Rs. 20,000 along with applicable taxes.
The CRIA once issued shall be valid for a period of 90 (ninety) days from the date of issuance and therefore the shipment of the said consignment must be performed during this validity period. In case, the goods are not shipped within this period, the exporter will have to re-apply for the pre-shipment inspection and testing process.
This process may be revised from time to time and the same will be communicated to you as and when the changes are implemented.
The timeline for the process may vary from within 24 hours for response to emails and document verification and 24-48 hours for scheduling the inspection upon request from the company. For analysis of medicines it would take between 6 to 15 days. The guidance document released by MCA also has various information including the product labelling requirements, quantity of sample required for testing, among other details.
In the wake of the adverse events reported related to the over-the-counter cough syrups with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG) the WHO has earlier released an urgent call to action to countries and the stakeholders to prevent, detect and respond to incidents of substandard and falsified medical products.
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