Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) has decided to insist on pre-shipment clearance for pharma exports from India.
Consignments without the Clean Report of Inspection and Analysis (CRIA) issued by agencies approved by the regulator will not be allowed from November 1, sources in Pharmaceuticals Export Promotion Council of India said after a meeting with NAFDAC officials on May 31.
As many as 100 pharmaceutical companies and pre-shipment agencies attended the meeting convened by Pharmexcil in the wake of the Nigerian drug regulator recently accusing India pharmaceutical manufacturers/exporters of indulging in unethical and unprofessional practices. Both sides approached the meeting seeking solutions, sources said, adding at $588.59 million 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 last month flagged the issue of exporters, in connivance with importers in Nigeria, not conforming to the product package 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 a statement recently, NAFDAC said “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 analysis in Nigeria. Full release is only consequent on a satisfactory laboratory analysis regardless of how long it takes to conclude the laboratory analysis and other regulatory activities.”
Any violative product boarded on airlines or shipping vessels from November 1, 2022 will be confiscated upon arrival in Nigeria and erring importer and manufacturer/exporter will be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting, it said.
