Nigeria’s medicines regulator, NAFDAC, has accused Indian pharmaceutical manufacturers and exporters of engaging in unethical and unprofessional practices to condone Nigerian importers and has warned them of harsh measures.
In a warning to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), the National Agency for Food and Drug Administration and Control (NAFDAC) claimed that the manufacturers from India are acting in an unethical and unprofessional manner when it comes to the design of product packaging and the formulation of medicines Practices resort to export of prescription drugs.
“It is widespread as several prescription drugs manufactured in India and registered in Nigeria are exported with outrageous, unauthorized pictorial representations and changes in the product formulations. This is also observed to be happening in collusion with Nigerian importers, resulting in importers, exporters and manufacturers changing the approved product formulation, color and packaging design to improve the visual appeal of prescription medicines to patients,” Pharmexcil said Warning from the Nigerian regulator to its members.
risk to public health
NAFDAC said the consequences are self-medication, drug abuse, as well as public health risks and national security challenges. It has issued a series of compliance and compliance decisions/instructions to all manufacturers and exporters of India, including ensuring strict adherence to NAFDAC registration guidelines, labeling and Good Manufacturing Practice regulations when registering the products.
“All prescription drugs and other categories of pharmaceutical products must strictly conform to NAFDAC-approved formulations and packaging designs. Manufacturers have been authorized a six-month moratorium to delete any shipment violating the approved formulations and packaging designs,” Pharmexcil’s statement said. The moratorium ends on October 30.
The Nigerian Authority said: “Any violating product taken on board by airlines or ships from November 1, 2022 will be confiscated upon arrival in Nigeria and any defective importer and manufacturer/exporter will be subject to severe penalties, sanctions, product de-registration and subject to the Black List.”
Urge member companies to comply with NAFDAC guidance for hassle-free exports to Nigeria, Pharmexcil Director General. Ravi Uday Bhaskar said the council also proposes to hold a meeting to understand the guidelines formulated by NAFDAC.