Accusing Indian pharmaceutical manufacturers and exporters of indulging in unethical and unprofessional practices in connivance with Nigerian importers, Nigeria’s drug regulator NAFDAC has warned them of stringent action.
In an alert to Pharmaceuticals Export Promotion Council of India (Pharmexcil), the National Agency for Food and Drug Administration and Control (NAFDAC) alleged that the manufacturers from India are resorting to unethical and unprofessional practices with regards to product package design and drug formulation for prescription only medicines exports.
“It has become rampant as 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,” Pharmexcil said conveying the alert of the Nigerian regulator to its members.
Public health risk
NAFDAC said the consequences would be self-medication, drug abuse as well as public health risk and national security challenges. It has notified a set of decisions/directions to all manufacturers and exporters of India, for adherence and compliance, including ensuring strict compliance to NAFDAC registration guidelines, labelling and Good Manufacturing Practice regulations as the products were registered.
“All prescription only medicines and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs. A moratorium of six months has been approved for manufacturers to clear every consignment that violate the approved formulations and package designs,” the Pharmexcil communication said. The moratorium ends on October 30.
The Nigerian agency has said “any violative product that is boarded on airlines or shipping vessels from November 1, 2022 will be confiscated upon arrival in Nigeria and any erring importer and manufacturer/exporter will be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting.”
Urging the member companies to adhere to NAFDAC directions for hassle free exports to Nigeria, Pharmexcil Director-General. Ravi Uday Bhaskar said the Council is also proposing to hold a meeting to understand the guidelines framed by the NAFDAC.