Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has determined to insist on pre-shipment clearance for pharma exports from India.
Consignments with out the Clean Report of Inspection and Analysis (CRIA) issued by businesses authorized by the regulator won’t be allowed from November 1, sources in Pharmaceuticals Export Promotion Council of India mentioned after a gathering with NAFDAC officers on May 31.
As many as 100 pharmaceutical corporations and pre-shipment businesses attended the assembly convened by Pharmexcil within the wake of the Nigerian drug regulator just lately accusing India pharmaceutical producers/exporters of indulging in unethical and unprofessional practices. Both sides approached the assembly looking for options, sources mentioned, including at $588.59 million exports, Nigeria was the fifth-largest marketplace for Indian prescription drugs.
The assembly was held to know the alleged violations and the plan of action Nigeria intends to take if it persists. NAFDAC had final month flagged the problem of exporters, in connivance with importers in Nigeria, not conforming to the product bundle design norms. “Several prescription medicines manufactured in India and registered in Nigeria are being exported with outrageous unapproved pictorial representation and change in product formulations. It is also observed that it is done in connivance with Nigerian importers leading to a situation where importers, exporters and manufacturers alter the approved product formulation, colour and package design in order to improve the pictorial appeal of prescription medicines to patients,” NAFDAC had alerted Pharmexcil.
In an announcement just lately, NAFDAC mentioned “clearance of products from China and India is contingent upon processing and issuance of CRIA issued by NAFDAC approved CRIA agents. Any regulated product from these countries without CRIA will be “On Hold” and sampled for laboratory evaluation in Nigeria. Full launch is barely consequent on a passable laboratory evaluation no matter how lengthy it takes to conclude the laboratory evaluation and different regulatory actions.”
Any violative product boarded on airways or delivery vessels from November 1, 2022 will likely be confiscated upon arrival in Nigeria and erring importer and producer/exporter will likely be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting, it mentioned.
Source: www.thehindu.com
