Western African nation The Gambia, where the deaths of at least 66 children last year was linked to an Indian cough syrup, has introduced a pre-shipment inspection and testing for Indian pharmaceuticals.
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In place since July 1, the requirement follows the country’s Medicines Control Agency (MCA) regulation mandating pre-shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis (CRIA) for pharmaceuticals. The country expects the proposal to address issues related to substandard and counterfeit medicines entering the country.
Also read: The lowdown on ‘substandard’ cough syrups
“This regulation requires all imported pharmaceutical products to be inspected and sampled for testing to ensure conformity to quality standards prior to shipment from India,” Indian pharma exporters body Pharmexcil said in a communication to its members.
The MCA has appointed independent verification, inspection and testing company Quntrol Laboratories to carry out the process and issue CRIA for all shipments. An importer will require a CRIA issued by Quntrol to clear their goods at the ports of entry in The Gambia.
Every country has its own systems in place to ensure quality, Pharmexcil Director General Ravi Uday Bhaskar said, pointing out that Nigeria has been for many years now following something similar.
Indian cough syrups also were under scanner last year following the death of 18 children in Uzbekistan. With effect from June 1 India is allowing export of cough syrup only after the sample is tested and a certificate of analysis (CoA) issued by one of the specified central governments labs as a measure to check quality,
Mr. Bhaskar said with more tests translating into additional time to exports “it is the responsibility of the manufacturer to release the product to the market by meeting all the desired and required parameters.” The need is to undertake a root cause analysis and identify the sources from where they are procuring material for the syrup.