The Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) has decided to insist on pre-shipment customs clearance for pharmaceutical exports from India.
Shipments without the Clean Report of Inspection and Analysis (CRIA) issued by agencies approved by the regulator will not be allowed from November 1, sources from the Pharmaceuticals Export Promotion Council of India said after a meeting with officials from the NAFDAC on May 31.
As many as 100 pharmaceutical companies and pre-shipment agencies attended the meeting called by Pharmexcil following the Nigerian drug regulator’s recent accusations against Indian pharmaceutical manufacturers/exporters of engaging in practices unethical and unprofessional. Both sides approached the meeting looking for solutions, sources said, adding that with $588.59 million in exports, Nigeria was the fifth largest market for Indian pharmaceuticals.
The meeting was held to understand the alleged violations and the course of action Nigeria intends to take if it persists. NAFDAC had flagged the problem last month of exporters, colluding with Nigerian importers, who were not complying with product packaging design standards. “Several prescription drugs manufactured in India and registered in Nigeria are exported with outrageous unapproved pictorial representation and changes in product formulations. It is also observed that this is done in collusion with Nigerian importers leading to a situation in which importers, exporters and manufacturers change the formulation, color and package design of the approved product to improve the visual appeal of prescription drugs for patients,” NAFDAC had alerted Pharmexcil.
In a recent statement, NAFDAC stated that “Customs clearance of products from China and India is dependent on the processing and issuance of CRIAs issued by NAFDAC-approved CRIA agents. Any regulated product from these countries without CRIA will be “on hold” and sampled for laboratory analysis in Nigeria. Full release is only following satisfactory laboratory analysis, regardless of the time it takes to conclude laboratory analysis and other regulatory activities.
Any offending product taken on board airlines or vessels from 1 November 2022 will be confiscated upon arrival in Nigeria and the offending importer and manufacturer/exporter will be subject to strict penalties, delisting of the product and the resulting blacklisting, he said.