The National Agency for Food and Drug Administration and Control (NAFDAC), in an alert to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), alleged that Indian manufacturers are resorting to unethical and unprofessional practices with regard to product package design and drug manufacturing . Export of prescription drugs only.
“This has become widespread as many drugs manufactured in India and registered in Nigeria are being exported with derogatory rejected graphical representations and changes in product formulations. It has also been observed that this is done in connivance with Nigerian importers, leading to a situation where importers, exporters and manufacturers have changed the approved product formulation, color and color to improve the pictorial appeal of prescription drugs for patients. The package design has changed. Nigerian regulator’s warning to its members.
NAFDAC said the consequences would be self-medication, drug abuse as well as public health risks and national security challenges. It has notified a set of decisions/directives for all manufacturers and exporters in India to follow and comply with, including ensuring strict compliance of NAFDAC registration guidelines, labeling and good manufacturing practice rules as the products were registered.
“All prescription only drugs and other categories of pharmaceutical products must strictly adhere to the formulation and package design approved by NAFDAC. Manufacturers have been given a moratorium of six months to approve every consignment that violates the approved formulation and package design. “The moratorium ends on October 30,” said Pharmexil Communications.
The Nigerian agency has stated, “With effect from November 1, 2022, any infringing product on board airlines or shipping vessels shall be confiscated upon arrival in Nigeria and any wrongful importer and manufacturer/exporter shall be subject to strict penalties, sanctions, product de-registration and The result will be subject to blacklisting.”
Urging the member companies to follow the NAFDAC directives for hassle free exports to Nigeria, the Director General of Pharmexcil. Ravi Uday Bhaskar said that the council is also proposing to hold a meeting to understand the guidelines framed by NAFDAC.
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